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FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/97ISR Number: 100000196Report Type:Expedited (15-DaCompany Report #97-10-0745 Age:40 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening PT Report Source Product Role Manufacturer Route Heart Rate Decreased Hypotension Consumer Baclofen Tablets PS Zenith Goldine Pharm. ORAL Manufacturer Route 10MG Q4-6HRS ORAL Tylenol C Date:11/10/97ISR Number: 100000225Report Type:Expedited (15-DaCompany Report #97F--10891 Age:37 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization DAILY, ORAL Initial or Prolonged PT Report Source Product Role Agitation Foreign Lioresal PS Clonic Convulsion Confusional State Hallucination Overdose Health Professional Other ORAL Date:11/12/97ISR Number: 3000337-7Report Type:Expedited (15-DaCompany Report #970566 Age:35 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Required DAY Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Bradycardia Hypertonia Mydriasis Foreign Health Professional Lioresal Inthrathecal (Balcofen Injection) PS Pulmonary Oedema Respiratory Arrest Manufacturer Route Date:11/19/97ISR Number: 3038112-XReport Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #97USA10819 PT Report Source Product Paraesthesia Oral Health Lioresal Parosmia Professional Role Manufacturer Route Duration Tablet PS ORAL 50 MG DAILY Date:11/19/97ISR Number: 3038114-3Report Type:Periodic Age:42 YR Gender:Male I/FU:I Outcome Dose 20 MG, TID PT Report Source Product Role Urticaria Consumer Lioresal Tablet PS 6 Route ORAL YR Company Report #97USA11792 PT Report Source Product Role Pulmonary Congestion Health Lioresal Tablet PS Manufacturer Route Duration PO Professional 22-Aug-2005 Page: 1 Manufacturer Duration Date:11/19/97ISR Number: 3038117-9Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Company Report #97USA10944 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/97ISR Number: 3038120-9Report Type:Periodic Age:16 MON Gender: I/FU:I Outcome Dose PT Report Source Product Role Impaired Gastric Emptying Health Professional Lioresal Tablet PS 10 MG, TID 20 MG, QID ORAL Company Report #96USA14950 PT Report Source Product Role Dizziness Nausea Vomiting Health Professional Baclofen Tablet PS Manufacturer Route ORAL Company Report #96USA14306 PT Report Source Product Role Coordination Abnormal Health Lioresal Tablet PS Dizziness Fatigue Hypoaesthesia Multiple Sclerosis Nausea Palpitations Sedation Vision Blurred Professional Manufacturer Route Duration 12 Company Report #96USA14623 PT Report Source Product Role Abdominal Pain Consumer Lioresal Tablet PS Duration 2 ORAL YR Date:11/19/97ISR Number: 3038605-5Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Route Duration Date:11/19/97ISR Number: 3038596-7Report Type:Periodic Age:59 YR Gender:Female I/FU:I Outcome Dose Manufacturer Duration Date:11/19/97ISR Number: 3038122-2Report Type:Periodic Age:16 YR Gender:Female I/FU:I Outcome Dose Company Report #97USA11812 YR Dermatitis Manufacturer Route Dysgeusia Insomnia Nasal Congestion Oedema Peripheral Vision Blurred Date:11/19/97ISR Number: 3038607-9Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #96USA14953 PT Report Source Product Role Alopecia Health Lioresal Tablet PS Manufacturer Route Duration ORAL PO Professional Date:11/19/97ISR Number: 3038608-0Report Type:Periodic Age:40 YR Gender:Male I/FU:I Outcome Dose Company Report #97USA10672 PT Report Source Product Role Confusional State Health Lioresal Tablet PS Hypertonia Professional Nortriptyline Tablet C 20 MG, TID 22-Aug-2005 Page: 2 Manufacturer Route Duration 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/97ISR Number: 3038611-0Report Type:Periodic Age:42 YR Gender:Male I/FU:I Outcome Dose Company Report #97USA10750 PT Report Source Product Role Urticaria Health Lioresal Tablet PS Manufacturer Route Duration 20 MG, TID 6 ORAL YR Professional Date:12/03/97ISR Number: 3004006-9Report Type:Expedited (15-DaCompany Report #970568 Age: Gender:Male I/FU:I Outcome Dose Death INTRATHECAL PT Report Source Product Role Company Lioresal Intrathecal PS Manufacturer Route Manufacturer Route Duration Blood Pressure Increased UNKNOWN Cardiac Disorder Representative DOSE/FREQUENC Faecaloma Y; Hyperthermia Malignant INTRATHECAL Hypertonia ROUTE Myocardial Infarction Pyrexia Date:12/03/97ISR Number: 3006825-1Report Type:Direct Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Bradycardia INTRAVENOUS 10 MG IV Q6 Initial or Prolonged Diplopia HOURS Other Lethargy Mental Disorder Date:12/09/97ISR Number: 3006598-2Report Type:Direct Age: Gender: I/FU:I Company Report # Report Source Product Role Baclofen PS Company Report # Outcome Dose PT Report Source Product Role Condition Aggravated Baclofen PS Drug Ineffective Baclofen SS Manufacturer Route Manufacturer Route Duration 20MG -5/DAY 20MG -5/DAY Hypertonia Date:12/24/97ISR Number: 3012858-1Report Type:Expedited (15-DaCompany Report #97F-10699 Age:19 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization DAILY, ORAL 6 WK Initial or Prolonged PT Report Source Product Role Leukopenia Foreign Lioresal PS Thrombocytopenia Health Professional Methotrexate Fraxiparine C C Date:12/24/97ISR Number: 3049149-9Report Type:Periodic Age:48 YR Gender:Male I/FU:I Outcome Dose Other PER ORAL 22-Aug-2005 Page: 3 ORAL Company Report #ZANA0319970300 PT Report Source Product Role Hepatitis Health Zanaflex PS Pyrexia Sedation Professional Baclofen Prozac Wellbutrin SS C C Manufacturer Route Duration 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/31/97ISR Number: 3013611-5Report Type:Expedited (15-DaCompany Report #97-10-0745 Age:40 YR Gender:Male I/FU:F Outcome Dose Duration Life-Threatening Hospitalization 10 MG Q4-6HRS Initial or Prolonged PT Report Source Product Role Manufacturer Route Heart Rate Decreased Hypotension Consumer Health Baclofen PS Zenith Goldline Pharm. ORAL Professional Tylenol Manufacturer Route Manufacturer Route C Date:01/02/98ISR Number: 3013617-6Report Type:Expedited (15-DaCompany Report #970579 Age:66 YR Gender:Male I/FU:I Outcome PT Dose Duration Required Asthenia INTRATHECAL 30.000MCG Intervention to Coma INTRATHECALLY Prevent Permanent Diplopia Impairment/Damage Dyspnoea Hypotension Medication Error Overdose Paralysis Flaccid Vision Blurred Report Source Product Role Literature Lioresal PS Health Professional Date:01/16/98ISR Number: 3016556-XReport Type:Expedited (15-DaCompany Report #98HQ-10019 Age:72 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 30MG DAILY Initial or Prolonged PT Report Source Product Role Confusional State Foreign Lioresal PS Depressed Level Of Consciousness Muscle Twitching Urinary Incontinence Literature Health Professional Hemodialysis C Date:01/23/98ISR Number: 3018003-0Report Type:Expedited (15-DaCompany Report #970581 Age:68 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization INTRATHECAL Initial or Prolonged PT Report Source Product Role Accidental Overdose Foreign Lioresal PS Dyspnoea Health Professional Manufacturer Route Manufacturer Route Manufacturer Route Date:01/27/98ISR Number: 3020705-7Report Type:Expedited (15-DaCompany Report #970582 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Coma INTRATHECAL INTRATHECAL Initial or Prolonged Overdose Date:02/04/98ISR Number: 3024237-1Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 4 12:15 PM Report Source Product Role Company Lioresal PS Representative Company Report # PT Report Source Product Role Medication Error Health Professional Baclofen PS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/06/98ISR Number: 3024846-XReport Type:Expedited (15-DaCompany Report #98J-10047 Age:31 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 10 MG DAILY, PT Report Source Product Role Depressed Level Of Foreign Lioresal PS Consciousness Health Hyponatraemia Inappropriate Antidiuretic Hormone Secretion Professional Dantrolene Etizolam` Carmellose Sodium Unknown Pantethine C C Manufacturer Route ORAL ORAL Date:02/13/98ISR Number: 3063706-5Report Type:Direct Age:72 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 1300MCG/DAY PT C C Company Report # Report Source Apnoea Product Role Baclofen PS Manufacturer Route Manufacturer Route Coma IT Condition Aggravated Hypertonia Sedation Date:02/17/98ISR Number: 3029669-3Report Type:Expedited (15-DaCompany Report #98D--10123 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 10 MG TID Initial or Prolonged ORAL PT Report Source Product Role Haemorrhage Foreign Lioresal PS Hepatic Cirrhosis Health Varices Oesophageal Professional Other Non-Steroidal Anti-I C ORAL Date:02/20/98ISR Number: 3032698-7Report Type:Expedited (15-DaCompany Report #98GB-10084 Age:56 YR Gender:Male I/FU:I Outcome Dose Other 10 MG, QID, PT Report Source Product Role Blindness Transient Foreign Lioresal PS Vision Blurred Health Ibuprofen Nifedipine C C Manufacturer Route Duration ORAL ORAL Professional Other Date:02/20/98ISR Number: 3032709-9Report Type:Expedited (15-DaCompany Report #98GB-10054 Age:52 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization DAILY, ORAL Initial or Prolonged PT Report Source Product Role Convulsion Foreign Baclofen PS Hypothermia Respiratory Acidosis Respiratory Arrest Health Professional Other Tamoxifen C Manufacturer Route ORAL Date:02/24/98ISR Number: 3036481-8Report Type:Expedited (15-DaCompany Report #970584 Age: Gender: I/FU:I Outcome Dose Death INTRATHECAL PT Report Source Product Role Overdose Foreign Lioresal PS Duration Company Representative 22-Aug-2005 Page: 5 12:15 PM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/24/98ISR Number: 3036483-1Report Type:Expedited (15-DaCompany Report #970581 Age: Gender:Male I/FU:F Outcome PT Dose Duration Hospitalization Accidental Overdose INTRATHECAL DAILY DOSE Initial or Prolonged Depressed Level Of UNKNOWN Consciousness AMOUNT Dyspnoea INTRATHECAL Renal Failure Acute Report Source Product Role Foreign Lioresal Intrathecal PS Manufacturer Route Manufacturer Route Health Professional Date:02/27/98ISR Number: 3037747-8Report Type:Expedited (15-DaCompany Report #98F--10125 Age:40 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 30 MG, DAILY, ORAL 2 PT Report Source Product Role Hepatic Enzyme Increased Foreign Lioresal PS ORAL Hepatitis Health Corticoids SS ORAL YR Professional ORAL Other Date:02/27/98ISR Number: 3037749-1Report Type:Expedited (15-DaCompany Report #98F--10124 Age:67 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Alanine Aminotransferase 10 MG, BID, Initial or Prolonged Increased ORAL 11 DAY Aspartate Aminotransferase Increased Hepatitis Report Source Product Role Foreign Lioresal PS Di-Antalvic Dafalgan C C Health Professional Other Manufacturer Route ORAL Date:03/16/98ISR Number: 3056638-XReport Type:Direct Age:8 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 50 MG AM, 25 Initial or Prolonged MG PM 3-4 Company Report # PT Report Source Product Role Crying Health Topiramate PS Irritability Professional Glycopyrrolate SS Baclofen SS Manufacturer Route Manufacturer Route Oliguria MONTHS 1 MG PO, 3-4 MONTHS Date:03/17/98ISR Number: 3056245-9Report Type:Expedited (15-DaCompany Report #98GB-10188 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization DAILY, ORAL Initial or Prolonged PT Report Source Product Role Agitation Foreign Lioresal PS Brain Stem Infarction Fall Health Professional Other Sinemet Bromocriptine Oxybutynin C C C Date:03/26/98ISR Number: 3060584-5Report Type:Expedited (15-DaCompany Report #F/98/00616/CAS Age:54 YR Gender:Female I/FU:I Outcome Life-Threatening Required Intervention to 22-Aug-2005 Page: 6 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prevent Permanent Impairment/Damage PT Dose Report Source Product Role Manufacturer Multiple Sclerosis Sandocal PS ORAL Status Epilepticus Lioresal SS ORAL Topalgic SS ORAL Senokot Motilium C C Route Duration 1 G ORAL 50 MG ORAL 200 MG ORAL Date:03/30/98ISR Number: 3068899-1Report Type:Expedited (15-DaCompany Report #980310-003010863 Age:54 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 200 MG, QD, Hospitalization ORAL Initial or Prolonged ORAL PT Report Source Product Role Amnesia Foreign Topalgic PS ORAL Convulsion Health Crepitations Professional Senna SS ORAL Domperidone SS ORAL Calcium Globionate SS ORAL Baclofen SS ORAL Disorientation 40MG, Manufacturer Route QD, Loss Of Consciousness ORAL Motor Dysfunction 100MG, QD, Multiple Sclerosis ORAL Salivary Hypersecretion 50 MG, QD, Status Epilepticus ORAL Date:04/01/98ISR Number: 3065060-1Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose PT Duration Company Report # Report Source Product Role Manufacturer Route Hospitalization Lethargy INTRATHECAL 2000 MCG/ML Initial or Prolonged Mental Impairment Vomiting Baclofen PS Apap Ibuprogen C C Date:04/06/98ISR Number: 3061250-2Report Type:Expedited (15-DaCompany Report #970589 Age:63 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Hyperhidrosis INTRAVENOUS 1200 MCQ/DAY; Initial or Prolonged Muscle Spasms INTRATHECAL Pyrexia Tachycardia Tachypnoea Report Source Product Role Foreign Lioresal PS Manufacturer Route Manufacturer Route Literature Health Professional Date:04/07/98ISR Number: 3060339-1Report Type:Expedited (15-DaCompany Report #98GB -10266 Age:37 YR Gender:Female I/FU:I Outcome Dose Other 10 MG, TID, ORAL PT Report Source Product Role Agitation Foreign Baclofen PS Bronchospasm Health Disorientation Loss Of Consciousness Professional Other Duration 1 DAY Date:04/07/98ISR Number: 3063443-7Report Type:Expedited (15-DaCompany Report #970591 Age:54 YR Gender:Male I/FU:I Outcome Death 22-Aug-2005 Page: 7 PT Death 12:15 PM Report Source Foreign Literature ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Health Professional Dose INTRATHECAL Product Role Lioresal PS Manufacturer Route Manufacturer Route Manufacturer Route Manufacturer Route Duration (INJECTION) Date:04/07/98ISR Number: 3063444-9Report Type:Expedited (15-DaCompany Report #970590 Age:65 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Hyperhidrosis INTRATHECAL 1100 MCG Initial or Prolonged Muscle Spasms (INJECTION)/D Pyrexia AY Tachycardia Tachypnoea Report Source Product Role Foreign Lioresal PS Literature Health Professional Date:04/09/98ISR Number: 3073686-4Report Type:Expedited (15-DaCompany Report #970592 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Coma INTRATHECAL 2000 MCG/ML Initial or Prolonged Medication Error INTRATHECAL Required Overdose Intervention to Prevent Permanent Impairment/Damage Report Source Product Role Health Lioresal PS Professional Date:04/15/98ISR Number: 3065703-2Report Type:Expedited (15-DaCompany Report #98USA10515 Age:74 YR Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Hospitalization DAILY ORAL Initial or Prolonged Small Intestinal Health Obstruction Professional Lioresal PS ORAL Date:04/16/98ISR Number: 3070742-1Report Type:Expedited (15-DaCompany Report #970588 Age:21 YR Gender:Male I/FU:I Outcome Dose Other INTRATHECAL PT Report Source Product Role Foreign Lioresal PS Manufacturer Route Manufacturer Route Duration Haematemesis 700 MCG/DAY, Intestinal Functional Health INTRATHECAL Disorder Renal Impairment Professional Date:04/21/98ISR Number: 3065841-4Report Type:Expedited (15-DaCompany Report #98USA10556 Age:75 YR Gender:Female I/FU:I Outcome Dose Other DAILY ORAL 22-Aug-2005 Page: 8 PT Report Source Product Role Coma Health Lioresal PS Professional Lescol Atenolol Ticlid C C C Duration 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/24/98ISR Number: 3068804-8Report Type:Expedited (15-DaCompany Report #98F--10306 Age:45 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 60 MG Initial or Prolonged (TABLET), DAILY 9 PT Report Source Product Role Alanine Aminotransferase Foreign Lioresal PS Increased Health Hepatic Necrosis Professional Manufacturer Route ORAL WK Hepatitis Date:04/28/98ISR Number: 3073283-0Report Type:Expedited (15-DaCompany Report #970584 Age: Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Overdose Foreign Company Representative Lioresal PS Manufacturer Route Manufacturer Route Duration Date:04/28/98ISR Number: 3073284-2Report Type:Expedited (15-DaCompany Report #970566 Age:35 YR Gender:Female I/FU:I Outcome PT Dose Duration Death Bradycardia INTRATHECAL 250MCG/DAY/IN Hospitalization Coma TRATHECAL Initial or Prolonged Muscle Spasticity Mydriasis Pulmonary Oedema Respiratory Arrest Shock Report Source Product Role Foreign Lioresal PS Health Professional Date:04/30/98ISR Number: 3074373-9Report Type:Expedited (15-DaCompany Report #98F--10316 Age:46 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 500 MG, Initial or Prolonged ONCE,ORAL, PT Report Source Product Role Agitation Foreign Lioresal PS Coma Health Pneumonia Aspiration Professional Suicide Attempt Distributor Other Manufacturer Route ORAL TAB Date:04/30/98ISR Number: 3074374-0Report Type:Expedited (15-DaCompany Report #98USA10617 Age:80 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 5 MG, TID, PT Report Source Product Role Confusional State Health Lioresal PS Feeling Jittery Professional Manufacturer Route ORAL ORAL, TAB Status Epilepticus Tongue Discolouration Date:05/01/98ISR Number: 3073162-9Report Type:Direct Age:54 YR Gender:Male I/FU:I Outcome Dose PT Report Source Product Role Baclofen PS Duration Agitation 10 MG TID X 5 Confusional State DAYS 22-Aug-2005 Page: 9 Company Report # 12:15 PM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/05/98ISR Number: 3073588-3Report Type:Expedited (15-DaCompany Report #970588-1 Age:21 YR Gender:Male I/FU:F Outcome Dose Other INTRATHECAL PT Report Source Product Role Foreign Lioresal PS Manufacturer Route Manufacturer Route Duration Apallic Syndrome 700 MCG/DAY, Autonomic Neuropathy Health INTRATHECAL Bladder Disorder Gastrointestinal Disorder Haematemesis Professional Date:05/05/98ISR Number: 3073597-4Report Type:Expedited (15-DaCompany Report #98USA10515 Age:74 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization (TABLET) Initial or Prolonged DAILY PT Report Source Product Role Small Intestinal Health Lioresal PS Obstruction Professional ORAL Date:05/15/98ISR Number: 3079236-0Report Type:Expedited (15-DaCompany Report #970597 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization INTRATHECAL 30 MG; Initial or Prolonged MG/30 ML PT Report Source Product Role Accidental Overdose 30 Disorientation Foreign Lioresal PS Drug Withdrawal Syndrome Professional Health INTRATHECAL Hypotension Medication Error Date:05/20/98ISR Number: 3080403-0Report Type:Direct Age:72 YR Gender:Male I/FU:I Company Report # Manufacturer Route Outcome Dose Other 20 MG NG QD PT Report Source Product Role Cerebrovascular Accident Fluoxetine PS Dystonia Baclofen SS Manufacturer Route Manufacturer Route Duration 5-15 MG TID Encephalopathy NG Hallucination Hypertonia Muscle Rigidity Staring Tremor Date:05/28/98ISR Number: 3084737-5Report Type:Expedited (15-DaCompany Report #98D-10328 Age:84 YR Gender:Male I/FU:I Outcome Dose Duration Death 1 DF, BID, Life-Threatening ORAL Hospitalization 3 DE, DAILY, Initial or Prolonged ORAL PT Report Source Product Role Arrhythmia Foreign Lioresal PS ORAL Atrial Flutter Health Phlebothrombosis Professional Euglucon N SS ORAL Adumbran SS ORAL Heparin SS Sotalex SS ORAL Sotalex SS ORAL Hypnomidate Ampoule SS Pneumonia Rash Erythematous 1 DF, DAILY, Staphylococcal Sepsis ORAL Urinary Tract Infection 25000 I.E. INTRAVENOUS DAILY INTRAVENOUS 40 MG, DAILY, ORAL 2 DF, DAILY ORAL 10 MG, DAILY 22-Aug-2005 Page: 10 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tramal Drops SS Tambocor Ampoule SS Novalgin Drops SS ORAL 15 DRP, DAILY, ORAL 2 DF, DAILY ORAL 30 DRP, DAILY ORAL Date:06/04/98ISR Number: 3090258-6Report Type:Direct Age:49 YR Gender:Female I/FU:I Outcome PT Dose Duration Life-Threatening Cardiac Arrest INTRATHECAL INTRATHECAL Required Coma 10 MG Intervention to Hypotension Prevent Permanent Lethargy Impairment/Damage Company Report # Report Source Product Role Baclofen PS Asa Tylenol C C Manufacturer Route Manufacturer Route Date:06/04/98ISR Number: 3091096-0Report Type:Expedited (15-DaCompany Report #199811483HPD Age:84 YR Gender:Male I/FU:I Outcome PT Dose Duration Death Pneumonia Life-Threatening Skin Disorder 2-1-0 U QD PO Hospitalization Staphylococcal Sepsis 2-1-0 U QD PO Initial or Prolonged Stevens-Johnson Syndrome INTRAVENOUS 25000 IU/DAY Toxic Epidermal IV Necrolysis Report Source Product Role Foreign Study Novalgin Euglucon N PS SS ORAL Health Azuglucon SS ORAL Professional Heparin SS Augmentan Tramal Adumbran Lioresal Tambocor SS SS SS SS SS Sotalex Hypnomidate Sotalex Mite Dormicum Mono Embolex Zantic Acimethin Novodigal Glucobay Digostada Nizax SS SS SS SS C C C C C C C Date:06/11/98ISR Number: 3093410-9Report Type:Expedited (15-DaCompany Report #98USA10556 Age:75 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening DAILY, ORAL Hospitalization Initial or Prolonged Other PT Report Source Product Role Coma Health Liorseal PS Professional Lescol Capsule Atenolol Tablet Ticlid Tablet C C C Date:06/12/98ISR Number: 3093492-4Report Type:Expedited (15-DaCompany Report #970568 Age: Gender:Male I/FU:I Outcome Death 22-Aug-2005 Page: 11 PT Autonomic Neuropathy Faecaloma 12:15 PM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypertension Hypertonia Myocardial Infarction Dose INTRATHECAL Report Source Product Role Company Lioresal Intrathecal PS Manufacturer Route Manufacturer Route Manufacturer Route Manufacturer Route Duration Pyrexia UKNOWN DOSE Representative Date:06/24/98ISR Number: 3098110-7Report Type:Expedited (15-DaCompany Report #970600 Age: Gender:Male I/FU:I Outcome Dose PT Report Source Product Role Unevaluable Event Foreign Health Professional Lioresal PS Duration Date:06/24/98ISR Number: 3098117-XReport Type:Expedited (15-DaCompany Report #98S--10034 Age:52 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Pruritus INTRATHECAL 338 MCG, Initial or Prolonged Rash Generalised DAILY, Toxic Skin Eruption INTRATHECAL Report Source Product Role Foreign Lioresal PS Propavan C Other Date:06/24/98ISR Number: 3098123-5Report Type:Expedited (15-DaCompany Report #970602 Age: Gender:Female I/FU:I Outcome Dose PT Report Source Product Role Unevaluable Event Foreign Consumer Lioresal Intrathecal PS Duration Date:06/24/98ISR Number: 3098128-4Report Type:Expedited (15-DaCompany Report #98D--10348 Age:49 YR Gender:Female I/FU:I Outcome Dose Other INTRATHECAL PT Report Source Product Role Foreign Lioresal PS Manufacturer Route Manufacturer Route Duration Flushing 500 MCG, Suicidal Ideation Consumer DAILY, Other INTRATHECAL 5 MON Date:06/24/98ISR Number: 3098130-2Report Type:Expedited (15-DaCompany Report #98D--10348 Age:49 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization INTRATHECAL DAILY, Initial or Prolonged INTRATHECAL 5 MON Other PT Report Source Product Role Flushing Foreign Lioresal PS Hypertonia Consumer Pruritus Suicidal Ideation Date:06/26/98ISR Number: 3098736-0Report Type:Direct Age:63 YR Gender:Female I/FU:I Outcome Life-Threatening 22-Aug-2005 Page: 12 12:15 PM PT Clonic Convulsion Depressed Level Of Consciousness Pain In Extremity Company Report # FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Renal Failure Chronic Stupor Tachypnoea Dose Report Source Product Role Baclofen PS Isordil Lepovir Dorvil Estrogen Regulin Ancef C C C C C C Manufacturer Route Duration ORAL 10 MG PO 1700 AND 2300 Date:06/29/98ISR Number: 3100132-4Report Type:Expedited (15-DaCompany Report #970606 Age:71 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Atrioventricular Block INTRATHECAL 2000 MCG/DAY, Initial or Prolonged Complete INTRATHECAL 17 DAY Required Blood Pressure Decreased Intervention to Bradycardia Prevent Permanent Drug Effect Decreased Impairment/Damage Muscle Spasms Report Source Product Role Foreign Lioresal PS Atropine Diazepam Fentanyl Urapidil Midazolam Dopamine Pancuronium C C C C C C C Manufacturer Route Manufacturer Route Health Professional Date:06/29/98ISR Number: 3100466-3Report Type:Expedited (15-DaCompany Report #970609 Age:41 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Condition Aggravated INTRATHECAL 2000 MCG/DAY; Initial or Prolonged Drug Effect Decreased INTRATHECAL Required Musculoskeletal Stiffness Intervention to Sedation Report Source Product Role Foreign Lioresal PS Pancuronium Diazepam C C Literature Health Professional Prevent Permanent Impairment/Damage Trismus Flumanezil C Date:06/29/98ISR Number: 3100467-5Report Type:Expedited (15-DaCompany Report #970608 Age:52 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Hypopnoea INTRATHECAL 500 MCG/DAY, Initial or Prolonged Sedation INTRATHECAL Required Intervention to Prevent Permanent Impairment/Damage Report Source Product Role Foreign Lioresal PS Diazepam Pancuronium Flumazenil C C C Manufacturer Route Manufacturer Route Literature Health Professional Date:06/29/98ISR Number: 3100468-7Report Type:Expedited (15-DaCompany Report #970607 Age:66 YR Gender:Female I/FU:I Outcome PT Dose Duration Life-Threatening Drug Effect Decreased INTRATHECAL VARIOUS; Required Hypotension INTRATHECAL 54 DAY Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 13 12:15 PM Report Source Product Role Foreign Lioresal PS Midazolam Pancuromium Atropine C C C Literature Health Professional FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dopamine Diazepam Flumazenil C C C Date:06/29/98ISR Number: 3100948-4Report Type:Expedited (15-DaCompany Report #970605 Age:57 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening INTRATHECAL INTRATHECAL PT Bradycardia Cardiac Arrest 40 MG, DAILY, Electrocardiogram St 16 MON Segment Elevation Heart Rate Irregular Hypotension Hypothermia Hypoventilation Loss Of Consciousness Medication Error Myocardial Infarction Respiratory Failure Report Source Product Role Foreign Health Lioresal Intrathecal (Baclofen Injection) PS Aspirin Glyceril Trinitrate ??? C C C Manufacturer Route Manufacturer Route Professional Date:06/29/98ISR Number: 3100951-4Report Type:Expedited (15-DaCompany Report #98GB-10607 Age:59 YR Gender:Female I/FU:I Outcome PT Dose Duration Life-Threatening Bradycardia INTRATHECAL 40 MG DAILY Cardio-Respiratory Arrest INTRATHECAL 16 MON Heart Rate Irregular Hypotension Hypothermia Hypotonia Hypoventilation Myocardial Infarction Syncope Report Source Product Role Foreign Lioresal (Baclofen) PS Aspirin Glyceryl Trinitrate Amdur Fastin C C C C Health Professional Date:07/01/98ISR Number: 3100331-1Report Type:Expedited (15-DaCompany Report #98D-10374 Age:57 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Antinuclear Antibody Positive Foreign Health Tegretal (Carbamazepine) PS ORAL Drug Toxicity Professional Lioresal (Baclofen) SS ORAL Jarsin Sugar-Coated Dytide H C C Duration 600 MG, DAILY, ORAL 89 DAY Hepatic Haemorrhage 50 MG DAILY, Hepatic Necrosis ORAL 67 DAY Hepatotoxicity Liver Function Test Abnormal Date:07/07/98ISR Number: 3102583-0Report Type:Expedited (15-DaCompany Report #98F-10529 Age:40 YR Gender:Male I/FU:I Outcome Dose Duration Other 2.5 MG, TID, PT Report Source Product Role Coma Foreign Lioresal PS Hypoglycaemia Health Pevaryl SS Zovirax Prozac SS SS Manufacturer Route ORAL ORAL Professional TOPICAL TOPICAL/LOCAL ORAL 22-Aug-2005 Page: 14 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Parenteral Nutrition Solution C Date:07/07/98ISR Number: 3102790-7Report Type:Expedited (15-DaCompany Report #98USA10999 Age:54 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization DIALY, ORAL Initial or Prolonged PT Report Source Product Role Pyrexia Health Lioresal PS Manufacturer Route ORAL Professional Date:07/16/98ISR Number: 3105955-3Report Type:Expedited (15-DaCompany Report #98I--10029 Age:15 YR Gender:Male I/FU:I Outcome Dose PT Report Source Product Role Dermatitis Foreign Lioresal PS ORAL Pyrexia Health Tegretol SS ORAL Vancomycin SS Heparin Propranolol C C Manufacturer Route Duration 75 MG,DAILY, ORAL Professional 800 MG, Other DAILY, ORAL INTRAVENOUS 2G, DAILY Date:07/17/98ISR Number: 3106161-9Report Type:Expedited (15-DaCompany Report #98F--10565 Age: Gender: I/FU:I Outcome Dose Duration Life-Threatening 200 MG, ONCE, Hospitalization ORAL Initial or Prolonged PT Report Source Product Role Blood Creatine Foreign Lioresal PS Phosphokinase Increased Health Depressed Level Of Consciousness Professional Other Manufacturer Route ORAL Suicide Attempt Date:07/17/98ISR Number: 3106169-3Report Type:Expedited (15-DaCompany Report #970615 Age:4 YR Gender:Female I/FU:I Outcome Dose Duration Required 170MCG BOLUS, Intervention to INTRATHECAL Prevent Permanent Impairment/Damage PT Report Source Product Role Hypertension Health Lioresal PS Medication Error Professional 22-Aug-2005 Page: 15 12:15 PM Route Manufacturer Route Overdose Date:07/17/98ISR Number: 3108325-7Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 5MG 4 X DAILY Initial or Prolonged Manufacturer PT Company Report # Report Source Product Role Amnesia Baclofen PS Confusional State Coordination Abnormal Disorientation Hallucination Movement Disorder Famvir Tenormin Zestril Prevacid C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/22/98ISR Number: 3108483-4Report Type:Expedited (15-DaCompany Report #98J-10271 Age:46 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 20 MG DAILY Initial or Prolonged ORAL PT Report Source Product Role Depressed Level Of Foreign Lioresal PS Consciousness Health Respiratory Disorder Professional Manufacturer Route ORAL Date:07/27/98ISR Number: 3109297-1Report Type:Expedited (15-DaCompany Report #970617 Age: Gender:Male I/FU:I Outcome Dose Death INTRATHECAL PT Report Source Product Role Company Lioresal Intrathecal PS Manufacturer Route Manufacturer Route Manufacturer Route Duration Condition Aggravated APPROX. Hypertonia Representative 2000MCG/DAY, Procedural Site Reaction INTRATHECAL Date:07/30/98ISR Number: 3111411-9Report Type:Expedited (15-DaCompany Report #970588-2 Age:21 YR Gender:Male I/FU:F Outcome Dose Other INTRATHECAL PT Report Source Product Role Foreign Lioresal PS Duration Bladder Disorder 700 MCG/DAY, Haematemesis Health INTRATHECAL Intestinal Functional Disorder Professional Date:07/30/98ISR Number: 3111415-6Report Type:Expedited (15-DaCompany Report #970615-1 Age:4 YR Gender:Female I/FU:F Outcome Dose PT Duration Report Source Product Role Required Accidental Overdose INTRATHECAL 170 MCQ Intervention to Hypotension BOLUS, Prevent Permanent Respiratory Depression INTRATHECAL Impairment/Damage Sedation Health Lioresal PS Professional Date:07/31/98ISR Number: 3111269-8Report Type:Expedited (15-DaCompany Report #98GB-10641 Age:15 YR Gender:Unknown I/FU:I Outcome Dose Duration Hospitalization 40 MG, DAILY, Initial or Prolonged ORAL PT Report Source Product Role Hypothermia Foreign Baclofen PS Pro-Banthine Cephradine Prednisolone Ranitidine C C C C Manufacturer Route ORAL Health Professional Date:08/05/98ISR Number: 3115239-5Report Type:Expedited (15-DaCompany Report #98GB-10787 Age:49 YR Gender:Male I/FU:I Outcome Dose Duration Other 25 MG DAILY, PT Report Source Product Role Liver Function Test Foreign Baclofen PS Abnormal Health ORAL Professional 22-Aug-2005 Page: 16 12:15 PM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/05/98ISR Number: 3226195-3Report Type:Periodic Age:37 YR Gender:Male I/FU:I Outcome Dose Other Company Report #98-03-0039 PT Report Source Product Role Blood Insulin Increased Hepatic Function Abnormal Hypoglycaemia Consumer Baclofen - Zenith Goldline Pharm. Tablets PS Vicodin Tenoretic Cytotec Naproxen Tagamet C C C C C Manufacturer Route Duration ORAL 60MG/DAY ORAL Date:08/05/98ISR Number: 3226201-6Report Type:Periodic Age:61 YR Gender:Male I/FU:I Outcome Dose Other Company Report #97-10-0729 PT Report Source Product Role Muscular Weakness Pollakiuria Consumer Baclofen - Zenith Goldline Pharm. Tablets PS Prednisone Therapy C Manufacturer Route Duration ORAL 10MG 1/2QHS ORAL Date:08/05/98ISR Number: 3226206-5Report Type:Periodic Age:30 YR Gender:Male I/FU:I Outcome Dose Other Company Report #97-12-0815 PT Report Source Product Role Dizziness Headache Muscle Rigidity Consumer Baclofen - Zenith Goldline Pharm. Tablets PS Manufacturer Route Duration 10MG BID ORAL Muscle Spasms Paraesthesia Tremor ORAL Date:08/05/98ISR Number: 3226211-9Report Type:Periodic Age:37 YR Gender:Female I/FU:I Outcome Dose Other Company Report #98-04-0096 PT Report Source Product Role Heart Rate Increased Paraesthesia Sedation Consumer Baclofen - Zenith Goldline Pharm Tablets PS Paxil Flexeril Ambien Morphine Sulfate Clonidine Patch C C C C C Manufacturer Route Duration ORAL 40-60 MG/DAY Sleep Apnoea Syndrome ORAL Date:08/05/98ISR Number: 3226215-6Report Type:Periodic Age:64 YR Gender:Male I/FU:F Outcome Dose Other Company Report #97-05-0385 PT Report Source Product Role Cerebrovascular Accident Vomiting Health Professional Other Baclofen - Zenith Goldline Pharm. Tablets PS Asa Coumadin Centrum C C C 5MG TID ORAL 22-Aug-2005 Page: 17 Manufacturer Route Duration 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zoloft Date:08/05/98ISR Number: 3226758-5Report Type:Periodic Age:49 YR Gender:Female I/FU:I Outcome Dose Other C Company Report #98-01-0003 PT Report Source Product Role Manufacturer Route Asthenia Bladder Disorder Constipation Hypersomnia Consumer Other Baclofen Tablets-Zenith Goldline Pharm. PS Zenith Goldline Pharm. ORAL Duration 20MG TID ORAL Increased Appetite Muscle Spasms Urinary Retention Urinary Tract Disorder Vision Blurred Ms Contin Klonopin Soma Date:08/05/98ISR Number: 3226759-7Report Type:Periodic Age:26 YR Gender:Female I/FU:I Outcome Dose Other C C C Company Report #97-12-0818 PT Report Source Product Role Manufacturer Route Drug Ineffective Health Professional Baclofen PS Zenith Goldline Pharm. ORAL Duration 20 MG 5/DAY Other ORAL Baclofen Capsules SS ORAL 20 MG 5/DAY ORAL Date:08/07/98ISR Number: 3114212-0Report Type:Expedited (15-DaCompany Report #970621 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Respiratory Depression Sedation Foreign Health Professional Lioresal PS Manufacturer Route Date:08/07/98ISR Number: 3114361-7Report Type:Expedited (15-DaCompany Report #98D--10461 Age: Gender:Unknown I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Bradycardia Coma Hypotension Overdose Respiratory Depression Foreign Health Professional Distributor Lioresal PS Manufacturer Route Manufacturer Route Date:08/14/98ISR Number: 3117305-7Report Type:Expedited (15-DaCompany Report #98J-10271 Age:46 YR Gender:Male I/FU:F Outcome PT Dose Duration Hospitalization Depressed Level Of 20 MG DAILY Initial or Prolonged Consciousness ORAL 4 DAY Haemodialysis Hypoaesthesia Lethargy Renal Failure Chronic Respiratory Disorder 22-Aug-2005 Page: 18 12:15 PM Report Source Product Role Foreign Lioresal PS Tegretol C Health Professional ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/16/98ISR Number: 3117258-1Report Type:Expedited (15-DaCompany Report #98F-10565 Age: Gender:Female I/FU:F Outcome Dose Duration Life-Threatening 200 MG ONCE PT Report Source Product Role Blood Creatine Foreign Lioresal PS Phosphokinase Increased Health Depressed Level Of Consciousness Hypotonia Rhabdomyolysis Sedation Suicide Attempt Professional Manufacturer Route ORAL ORAL Date:08/18/98ISR Number: 3118773-7Report Type:Expedited (15-DaCompany Report #FLUV001980094 Age:30 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization PER ORAL Initial or Prolonged PER ORAL PT Report Source Product Role Manufacturer Prothrombin Time Floxyfral PS ORAL Shortened Sermion SS ORAL Lioresal SS ORAL Dantrium SS ORAL Route PER ORAL 3 DOSAGES DAILY PER ORAL Date:08/19/98ISR Number: 3118900-1Report Type:Expedited (15-DaCompany Report #99D-10374 Age:57 YR Gender:Female I/FU:F Outcome Dose Duration Other 600 MG DAILY ORAL 89 DAY PT Report Source Product Role Antinuclear Antibody Foreign Tegretal PS Positive Health Manufacturer Route ORAL Hepatic Haemorrhage Professional Hepatic Necrosis Other Lioresal SS Jarsin Sugar-Coated Tablet Dytide H C C ORAL 50 MG DAILY ORAL 67 DAY Liver Function Test Abnormal Date:08/20/98ISR Number: 3242793-5Report Type:Periodic Age:44 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged BOLUS DOSE OF Company Report #970545 PT Report Source Product Role Bradycardia Confusional State Foreign Literature Lioresal Intrathecal (Baclofen Injection) PS Dyspnoea Health Hypertonia Professional Manufacturer Route Manufacturer Route 0.2 ML OF 500 MCG/ML Hypotonia Sedation Date:08/20/98ISR Number: 3242797-2Report Type:Periodic Age:38 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 100 MCG BOLUS Company Report #970546 PT Report Source Product Role Convulsion Foreign Literature Lioresal Intrathecal (Baclofen Injection) PS Health DOSE Professional 22-Aug-2005 Page: 19 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/98ISR Number: 3242806-0Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Role Hypotonia Literature Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route Company Report #970548 PT Report Source Product Role Hypotonia Literature Health Professional Lioresal Intrathecal (Baclofen Injection) PS Company Report #970549 PT Report Source Product Role Hypotonia Literature Health Professional Lioresal Intrathecal (Baclofen Injection) PS Duration Date:08/20/98ISR Number: 3242815-1Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Other Route Duration Date:08/20/98ISR Number: 3242813-8Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Other Manufacturer Duration Date:08/20/98ISR Number: 3242810-2Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Other Company Report #970547 Company Report #970550 PT Report Source Product Role Urinary Retention Literature Health Professional Lioresal Intrathecal (Baclofen Injection) PS Duration Date:08/20/98ISR Number: 3242817-5Report Type:Periodic Age: Gender:Unknown I/FU:I Company Report #970551 Outcome Dose Other PT Report Source Product Role Urinary Retention Literature Health Professional Lioresal Intrathecal (Baclofen Injection) PS Date:08/20/98ISR Number: 3242819-9Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Other 22-Aug-2005 Page: 20 Route Manufacturer Route Manufacturer Route Company Report #970552 PT Report Source Product Role Urinary Retention Literature Health Professional Lioresal Intrathecal (Baclofen Injection) PS Duration Date:08/20/98ISR Number: 3242820-5Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Other Manufacturer Duration Company Report #970553 PT Report Source Product Role Dizziness Nausea Sedation Literature Health Professional Lioresal Intrathecal (Baclofen Injection) PS Duration 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/98ISR Number: 3242822-9Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Role Confusional State Hypotonia Foreign Literature Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route Manufacturer Route Duration Date:08/20/98ISR Number: 3242824-2Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #970554 Company Report #970555 PT Report Source Product Role Condition Aggravated Hypertonia Health Professional Lioresal Intrathecal (Baclofen Injection) PS Duration 390 MCG/DAY OF 2000 MCG/ML Date:08/20/98ISR Number: 3242826-6Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other INTRATHECAL Company Report #970556 PT Report Source Product Role Hypotonia Company Representative Lioresal Intrathecal (Baclofen Injection) PS Duration UNKNOWN; INTRATHECAL Date:08/20/98ISR Number: 3242828-XReport Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization - Company Report #970558 PT Report Source Product Hypertonia Foreign Lioresal Intrathecal Role Initial or Prolonged INTRATHECAL 250 MCG/DAY Health (Baclofen Injection) PS Professional INTRATHECAL Date:08/20/98ISR Number: 3242829-1Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other INTRATHECAL Company Report #970562 PT Report Source Product Role Urinary Incontinence Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Duration UNKNOWN DOSE, INTRATHECAL DELIVERY Date:08/20/98ISR Number: 3242831-XReport Type:Periodic Age:4 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Convulsion Initial or Prolonged INTRATHECAL 48 MCG INTRATHECAL BOLUS 22-Aug-2005 Page: 21 12:15 PM Company Report #970567 Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/98ISR Number: 3242832-1Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other INTRATHECAL PT Company Report #970569 Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route Manufacturer Route Duration Condition Aggravated Hypertonia 105 MCG/DAY, INTRATHECAL Date:08/20/98ISR Number: 3242833-3Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other INTRATHECAL PT Company Report #970570 Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Duration Condition Aggravated Hypertonia 264 MCG/DAY, INTRATHECAL Date:08/20/98ISR Number: 3242835-7Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other INTRATHECAL PT Company Report #970571 Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Duration Condition Aggravated Hypertonia 638 MCG/DAY, INTRATHECAL Date:08/20/98ISR Number: 3242837-0Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other INTRATHECAL PT Company Report #970572 Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Duration Condition Aggravated Hypertonia 161 MCG/DAY, INTRATHECAL Date:08/20/98ISR Number: 3242840-0Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other INTRATHECAL Company Report #970573 PT Report Source Product Role Hypertonia Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route Duration 508 MCG/DAY, INTRATHECAL Date:08/20/98ISR Number: 3249289-5Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #970574 PT Report Source Product Role Hypertonia Health Professional Lioresal Intrathecal (Baclofen Injection) PS Duration 831 MCG/DAY, INTRATHECAL Date:08/20/98ISR Number: 3249303-7Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Condition Aggravated Hypertonia Health Professional Lioresal Intrathecal (Baclofen Injection) PS Duration 830 MCG/DAY, INTRATHECAL 22-Aug-2005 Page: 22 Company Report #970575 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/98ISR Number: 3249307-4Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #970576 PT Report Source Product Role Condition Aggravated Hypertonia Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route Manufacturer Route Duration 260 MG/DAY, INTRATHECAL Date:08/20/98ISR Number: 3249311-6Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 400 MCG/DAY, Company Report #970577 PT Report Source Product Role Sedation Literature Health Lioresal Intrathecal (Baclofen Injection) PS Professional INTRATHECAL Date:08/20/98ISR Number: 3249353-0Report Type:Periodic Age:19 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 200 MCG/DAY, Company Report #970578 PT Report Source Product Role Sedation Literature Health Lioresal Intrathecal (Baclofen Injection) PS Professional INTRATHECAL Date:08/20/98ISR Number: 3249361-XReport Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other 500 MCG/DAY, Company Report #970580 PT Report Source Product Role Hypertonia Pruritus Health Professional Lioresal Intrathecal (Baclofen Injection) PS Duration Sedation INTRATHECAL Oral Baclofen, Dose Unknown Date:08/20/98ISR Number: 3249369-4Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged DOSE UNKNOWN, C Company Report #970585 PT Report Source Product Role Hypotonia Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route INTRATHECAL ROUTE Date:08/20/98ISR Number: 3249375-XReport Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Hypotonia Consumer Lioresal Intrathecal (Baclofen Injection) PS Duration UNK DOSE, INTRATHECAL ROUTE 22-Aug-2005 Page: 23 Company Report #970586 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/98ISR Number: 3249379-7Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #970587 PT Report Source Product Role Hypotonia Urinary Incontinence Study Health Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route Manufacturer Route Duration UNKNOWN DOSE; Professional INTRATHECAL ROUTE Date:08/20/98ISR Number: 3249383-9Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 330 MG BOLUS, Company Report #970593 PT Report Source Product Role Hypotonia Vomiting Health Professional Lioresal Intrathecal (Baclofen Injection) PS INTRATHECAL Date:08/20/98ISR Number: 3249387-6Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #970594 PT Report Source Product Role Sedation Health Professional Lioresal Intrathecal (Baclofen Injection) PS Duration UNKNOWN, INTRATHECAL Date:08/20/98ISR Number: 3249392-XReport Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization - Company Report #970595 PT Report Source Product Vomiting Company Lioresal Intrathecal Role Initial or Prolonged 87, MCG/DAY, Representative (Baclofen Injection) PS INTRATHECAL Date:08/20/98ISR Number: 3249395-5Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #970596 PT Report Source Product Role Hypotonia Sedation Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Duration UNKNOWN DOSE; INTRATHECAL ROUTE Date:08/20/98ISR Number: 3249398-0Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Convulsion Health Professional Lioresal Intrathecal (Baclofen Injection) PS Duration UNKNOWN DOSE; INTRATHECAL ROUTE 22-Aug-2005 Page: 24 Company Report #970598 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/98ISR Number: 3249402-XReport Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #970599 PT Report Source Product Role Hypotonia Study Health Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route Manufacturer Route Duration UNKNOWN DOSE; Professional INTRATHECAL ROUTE Date:08/20/98ISR Number: 3249405-5Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #970601 PT Report Source Product Role Dyspnoea Other Lioresal Intrathecal (Baclofen Injection) PS Duration 900 MG/DAY, INTRATHECAL Date:08/20/98ISR Number: 3249408-0Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #970603 PT Report Source Product Role Muscle Twitching Other Lioresal Intrathecal (Baclofen Injection) PS Duration 2 MCG/HOUR, INTRATHECAL Date:08/20/98ISR Number: 3249414-6Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #970604 PT Report Source Product Condition Aggravated Health Lioresal Intrathecal Duration Role Hypertonia Professional (Baclofen Injection) PS UNKNOWN DOSE, INTRATHECAL ROUTE Date:08/20/98ISR Number: 3249417-1Report Type:Periodic Age: Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Role Medical Device Complication Foreign Company Representative Lioresal Intrathecal (Baclofen Injection) PS Route Manufacturer Route Company Report #970611 PT Report Source Product Role Convulsion Health Professional Lioresal Intrathecal (Baclofen Injection) PS Trazadone Deserel Depakote C C C Duration UNKNOWN; INTRATHECAL 22-Aug-2005 Page: 25 Manufacturer Duration Date:08/20/98ISR Number: 3249420-1Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Death Company Report #970610 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/20/98ISR Number: 3249423-7Report Type:Periodic Age:22 YR Gender:Male I/FU:I Outcome Dose Other Company Report #970612 PT Report Source Product Role Drug Ineffective Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route Duration 375 MCG BOLUS AT TRIAL Date:08/20/98ISR Number: 3249426-2Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #970613 PT Report Source Product Role Ejaculation Disorder Erectile Dysfunction Foreign Literature Lioresal Intrathecal (Baclofen Injection) PS Duration UNKNOWN; Health INTRATHECAL Professional Date:08/21/98ISR Number: 3120458-8Report Type:Expedited (15-DaCompany Report #98F--10715 Age:30 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Prothrombin Time DAILY ORAL 4 WK Initial or Prolonged Shortened ORAL 3 MON Report Source Product Role Foreign Lioresal PS ORAL Health Sermion SS ORAL Professional Dantrium SS ORAL Floxyfral SS ORAL 300 MG DAILY ORAL ORAL Date:09/02/98ISR Number: 3125871-0Report Type:Direct Age:64 YR Gender:Male I/FU:I Company Report # Outcome Dose Other 20 MG BID, PT Report Source Product Role Manufacturer Route Baclofen PS ORAL Tegretol SS ORAL Oxycodone/Acetaminop hen Alendronate Sodium Bisacodyl C C C Duration Drug Ineffective ORAL 200 MG TID, ORAL Date:09/09/98ISR Number: 3127343-6Report Type:Expedited (15-DaCompany Report #970623 Age: Gender:Female I/FU:I Outcome PT Dose Duration Life-Threatening Confusional State INTRATHECAL INTRATHECAL Hospitalization Convulsion ROUTE Initial or Prolonged Drug Withdrawal Syndrome Hypertension Muscle Spasticity Report Source Product Role Health Lioresal Intrathecal PS Professional Date:09/11/98ISR Number: 3127618-0Report Type:Expedited (15-DaCompany Report #970626 Age: Gender:Male I/FU:I Outcome Required Intervention to Prevent Permanent 22-Aug-2005 Page: 26 12:15 PM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage Dose PT Report Source Product Role Asthenia Health Lioresal PS Drug Withdrawal Syndrome Professional Manufacturer Route Manufacturer Route Manufacturer Route Duration DOSE, INTRATHECAL Dyspnoea DELIVERY Hypertonia Medication Error Overdose Paraesthesia Pruritus Date:09/21/98ISR Number: 3133431-0Report Type:Expedited (15-DaCompany Report #98D--10461 Age:74 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Accidental Overdose Bradycardia Bradypnoea Coma Drug Level Above Therapeutic Hypotension Hypothermia Respiratory Depression Foreign Health Professional Other Lioresal Benzodiazepine PS SS Date:09/25/98ISR Number: 3135394-0Report Type:Expedited (15-DaCompany Report #96-01870 Age:65 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Abdominal Pain INTRAVENOUS 255 MG; Initial or Prolonged Asthenia INTRAVENOUS Other Deep Vein Thrombosis INTRAVENOUS 1020 MG Report Source Product Role Study Camptosar PS Adrucil SS Health Professional Hyperbilirubinaemia WEEKLY Hypotension INTRAVENOUS Pulmonary Embolism 40 MG WEEKLY INTRAVENOUS Leucovorin SS Baclofen SS ORAL Amitriptyline SS ORAL Prevacid Propulsid Carafate Paxil Megace Prilosec Axid Advil Duragesic Patch Acyclovir Indocin C C C C C C C C C C C INTRAVENOUS 10 MILLIGRAMS TID ORAL 50 MILLIGRAMS ONCE DAILY ORAL 22-Aug-2005 Page: 27 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/98ISR Number: 3136190-0Report Type:Expedited (15-DaCompany Report #98USA11417 Age:49 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Abnormal Behaviour 10MG TID ORAL 2 DAY Initial or Prolonged Mental Impairment Tremor Report Source Product Role Health Baclofen PS Professional Fosinopril Nifedipine Extended Release C Manufacturer Route ORAL C Date:09/29/98ISR Number: 3136285-1Report Type:Expedited (15-DaCompany Report #970628 Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Coma INTRATRACHEAL 229 MCG/DAY, Initial or Prolonged Dizziness INTRATHECAL Medication Error Report Source Product Role Health Lioresal PS Manufacturer Route Manufacturer Route Professional Date:10/02/98ISR Number: 3137390-6Report Type:Expedited (15-DaCompany Report #98--F10529 Age:41 YR Gender:Male I/FU:F Outcome Dose Duration Other 2.5 MG, BID, PT Report Source Product Role Coma Foreign Lioresal PS Hypoglycaemia Health Medication Error Professional Other Pevaryl Spray (Econazole Nitrate) SS ORAL ORAL TOPICAL TOPICAL/LOCAL Zovirax (Aciclovir) Prozac Drops(Fluoxetine) 10 DRP, DAILY, ORAL Parenteral Nutrition Solution(Parental SS SS ORAL Nutrition) PARENTERAL SS PARENTERAL Date:10/02/98ISR Number: 3137393-1Report Type:Expedited (15-DaCompany Report #98GB-10868 Age: Gender:Female I/FU:I Outcome Dose Other 10 MG, TID, PT Report Source Product Role Liver Function Test Foreign Lioresal PS Abnormal Health Amitriptyline Antibiotics C C Manufacturer Route Duration ORAL ORAL Professional Other Date:10/05/98ISR Number: 3138377-XReport Type:Expedited (15-DaCompany Report #970617 Age: Gender:Male I/FU:F Outcome Dose Death INTRATHECAL PT Report Source Product Role Company Lioresal PS Duration Death APPROX. 2000 Representative MCG/DAY, INTRATHECAL Date:10/15/98ISR Number: 3142510-3Report Type:Expedited (15-DaCompany Report #98J-10368 Age:63 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 28 12:15 PM PT Depressed Level Of Consciousness Report Source Foreign Health Professional Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Dose Product Role Lioresal PS Landsen Lendormin C C Manufacturer Route Duration ORAL 10 MG, DAILY, ORAL 2 DAY Date:10/22/98ISR Number: 3145451-0Report Type:Expedited (15-DaCompany Report #500691 Age:75 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 150 MG DAILY Initial or Prolonged ; ORAL PT Report Source Product Role Manufacturer Route Electroencephalogram Foreign Macrodantin PS ORAL Abnormal Health Epilepsy Professional Lioresal SS ORAL Lioresal C 20 MG DAILY ; Loss Of Consciousness ORAL Monoparesis Movement Disorder Tremor Urinary Incontinence Date:10/27/98ISR Number: 3245512-1Report Type:Periodic Age:44 YR Gender:Male I/FU:I Outcome Dose Other 50.00 MG Company Report #9830427 PT Report Source Product Role Manufacturer Route Drug Ineffective Consumer Viagra Tablets PS ORAL Baclofen SS ORAL Betaseron C Duration Erectile Dysfunction TOTAL:PRN:ORA L ORAL Amantidine Desyrel C C Date:10/28/98ISR Number: 3148398-9Report Type:Expedited (15-DaCompany Report #R98-063 Age: Gender: I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged TID PT Report Source Product Role Manufacturer Complications Of Maternal Exposure To Therapeutic Health Professional Baclofen PS Watson Laboratories Inc. Miami Hydrocortisone Tylenol #3 C C Drugs (28TH-29TH Foetal Movements WEEK -30TH Decreased WEEK OF Intraventricular PREGNANCY) Haemorrhage Neonatal Premature Baby Small For Dates Baby Date:11/04/98ISR Number: 3152136-3Report Type:Expedited (15-DaCompany Report #109/8697 Age:1 DY Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged Congenital Anomaly 22-Aug-2005 Page: 29 12:15 PM PT Complications Of Maternal Exposure To Therapeutic Drugs Foetal Movements Decreased Intraventricular Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Haemorrhage Neonatal Premature Baby Dose Report Source Product Role Health Professional Cortef Baclofen PS SS Company Representative Tylenol With Codeine SS Manufacturer Route Duration ORAL ORAL Date:11/04/98ISR Number: 3152476-8Report Type:Expedited (15-DaCompany Report #98F--10882 Age:71 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization DAILY, ORAL Initial or Prolonged PT Report Source Product Role Agitation Foreign Lioresal PS Confusional State Convulsion Health Professional Other Manufacturer Route ORAL Date:11/04/98ISR Number: 3152478-1Report Type:Expedited (15-DaCompany Report #98HQ-10387 Age:71 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 30 MG, DAILY, Initial or Prolonged ORAL PT Report Source Product Role Abdominal Pain Foreign Baclofen PS Cerebral Atrophy Literature Cerebral Infarction Confusional State Difficulty In Walking Encephalopathy Hypotonia Muscular Weakness Neurological Symptom Sedation Health Professional Other Hemodialysis C Date:11/04/98ISR Number: 3152479-3Report Type:Expedited (15-DaCompany Report #98HQ-10388 Age:69 YR Gender:Male I/FU:I Manufacturer Route ORAL Outcome Dose Duration Hospitalization 15 MG, DAILY, Initial or Prolonged ORAL PT Report Source Product Role Atrophy Foreign Baclofen PS Brain Stem Infarction Literature Cheyne-Stokes Respiration Coma Confusional State Health Professional Other Hemodialysis C Manufacturer Route ORAL Date:11/09/98ISR Number: 3153742-2Report Type:Expedited (15-DaCompany Report #98-10-0239 Age:48 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 10 MG BID PT Report Source Product Role Manufacturer Route Eye Disorder Motor Dysfunction Consumer Baclofen PS Zenith Goldline Pharm. ORAL Paralysis ORAL Darvocet-N 100 Meperidine Hydrochloride 22-Aug-2005 Page: 30 12:15 PM C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/09/98ISR Number: 3154503-0Report Type:Expedited (15-DaCompany Report #98F-10947 Age:34 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged DAILY, ORAL PT Report Source Product Role Manufacturer Route Coma Epilepsy Foreign Health Lioresal Tablet (Baclofen) PS ORAL Hypertonia Overdose Status Epilepticus Professional Vastarel Tablet (Trimetazidine Dihydrochloride) SS ORAL ORAL Suicide Attempt Date:11/09/98ISR Number: 3154708-9Report Type:Expedited (15-DaCompany Report #981104-107014347 Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Complications Of Maternal Initial or Prolonged Exposure To Therapeutic INTRA-UTERINE INTRAUTERINE Drugs Intraventricular INTRA-UTERINE INTRAUTERINE Haemorrhage Neonatal Premature Baby Report Source Product Role Health Professional Tylenol With Codeine #3 PS Hydrocortisone Baclofen SS SS Manufacturer Route Manufacturer Route Date:11/10/98ISR Number: 3155630-4Report Type:Expedited (15-DaCompany Report #500705 Age: Gender:Male I/FU:I Outcome Dose Other ORAL PT Report Source Product Role Arrhythmia Foreign Dantrium PS Health Professional Lioresal SS Duration Date:11/12/98ISR Number: 3157133-XReport Type:Expedited (15-DaCompany Report #98USA11651 Age:59 YR Gender:Male I/FU:I ORAL Outcome Dose Duration Hospitalization DAILY ORAL Initial or Prolonged PT Report Source Product Role Coma Health Baclofen PS Dyspnoea Facial Palsy Hemiparesis Hypertension Tongue Oedema Professional Procardia Capsule Compazine Tablet C C Manufacturer Route ORAL Date:11/18/98ISR Number: 3160814-5Report Type:Expedited (15-DaCompany Report #98F--11010 Age:63 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 15 MG, TID, Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Condition Aggravated Foreign Lioresal PS ORAL Extrapyramidal Disorder Health Hemiplegia Professional Mestinon SS ORAL Fonzylane SS ORAL Prozac SS ORAL Kardegic SS ORAL Glucor SS ORAL 60 MG, DAILY, Other ORAL 600 MG, DAILY, ORAL 20 MG, DAILY, ORAL 300 MG, DAILY, ORAL 300 MG, DAILY, ORAL 22-Aug-2005 Page: 31 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/18/98ISR Number: 3160815-7Report Type:Expedited (15-DaCompany Report #98--D11022 Age:12 YR Gender:Female I/FU:I Outcome Dose Other DAILY PT Report Source Product Role Electrolyte Imbalance Foreign Lioresal PS Health Professional Other Klistier SS Manufacturer Route Manufacturer Route Duration Date:11/20/98ISR Number: 3161642-7Report Type:Expedited (15-DaCompany Report #98USA11687 Age:79 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 5 MG, TID, Initial or Prolonged ORAL PT Report Source Product Role Aspiration Health Baclofen PS Respiratory Failure Professional Epogen Solution For Injecti Prilosec Trovan C C C Sedation ORAL Date:11/23/98ISR Number: 3163511-5Report Type:Expedited (15-DaCompany Report #98USA11651 Age:59 YR Gender:Male I/FU:F Outcome Dose Duration Life-Threatening 5 MG, TID, Hospitalization ORAL 24 HR Initial or Prolonged Disability PT Report Source Product Role Asthenia Health Baclofen PS Blood Pressure Increased Professional Prozac Catapres Procardia Capsules Erythromycin Solution For Infusion Regular Insulin Suspension Compazine Tablet C C C Coma Dyspnoea Facial Palsy Hypotension Loss Of Consciousness Nausea Stridor Tongue Oedema C C C Manufacturer Route ORAL Date:11/24/98ISR Number: 3163510-3Report Type:Expedited (15-DaCompany Report #98F-11034 Age:58 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 30 MG, DAILY, Initial or Prolonged ORAL PT Report Source Product Conduction Disorder Foreign Lioresal Myocardial Infarction Health Ventricular Tachycardia Professional Role (Baclofen) Manufacturer Route PS ORAL Tenormine (Atenolol) SS ORAL Dantrium (Dantrolene Sodium) SS ORAL Lexomil Fonzylane C C ORAL ORAL Date:11/25/98ISR Number: 3164084-3Report Type:Direct Age:74 YR Gender:Male I/FU:I Outcome Dose Other 22-Aug-2005 Page: 32 PT Company Report # Report Source Product Role Baclofen Insulin Reg Human Acetaminophen/Codein e Clindamycin PS C Duration Urinary Retention 12:15 PM C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Terazosin Petrolatum Camphor 0.5%/Menthol 0.5% Cetirizine Insulin Lente Human Lansoprazole Dorzolamide Timolol Ferrous Sulfate Calcium Carbonate Furosemide Nitroglycerin Bisacodyl Albuterol Acertaminophen Hydroxyzine Hcl Silver Sulfadiazine Finasteride Selenium Sulf Petrolatum Hydrophilic Neutrogena Soap Ketoconazole Casanthranol/Docusat e Aspirin Ec Nifedipine (Adalat Cc) C C C C C C C C C C C C C C C C C C C C C C C C C Date:12/02/98ISR Number: 3165923-2Report Type:Expedited (15-DaCompany Report #98F--10947 Age:34 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 300 MG, ONCE Initial or Prolonged 10 DF, ONCE PT Report Source Product Role Coma Foreign Lioresal PS ORAL Hypertonia Health Adalate SS ORAL Overdose Pneumonia Aspiration Pregnancy Test Positive Status Epilepticus Suicide Attempt Therapeutic Agent Professional Other Manufacturer Route Toxicity Vomiting Date:12/03/98ISR Number: 3166455-8Report Type:Expedited (15-DaCompany Report #98D--11022 Age:12 YR Gender:Female I/FU:F Outcome Dose Other DAILY, ORAL RECTAL 22-Aug-2005 Page: 33 PT Report Source Product Role Conversion Disorder Foreign Lioresal (Baclofen) PS Electrolyte Imbalance Fatigue Health Professional Klistier (Travad Phospate Enema) SS Gastrooesophageal Reflux Disease Hypernatraemia Hypokalaemia Metabolic Alkalosis Other Manufacturer Route Duration RECTAL 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/03/98ISR Number: 3166654-5Report Type:Expedited (15-DaCompany Report #500705 Age: Gender:Male I/FU:F Outcome Dose Other 50MG DAILY PT Report Source Product Role Manufacturer Route Arrhythmia Foreign Dantrium PS ORAL Myocardial Infarction Health Lioresal SS ORAL Professional Ditropan Fonzylane Lexomil Lioresal Tenormine C C C C C Duration 30MG DAILY Date:12/09/98ISR Number: 3168692-5Report Type:Expedited (15-DaCompany Report #R98-068 Age:49 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 2 QID PT Report Source Product Role Manufacturer Convulsion Medication Error Consumer Other Baclofen PS Watson Laboratories, Miami Div. Amantidine C Route Date:12/14/98ISR Number: 3170601-XReport Type:Expedited (15-DaCompany Report #970629 Age: Gender:Female I/FU:I Outcome Dose Death INTRATHECAL PT Report Source Product Role Health Lioresal PS Manufacturer Route Manufacturer Route Duration Pyrexia INTRATHECAL Professional ROUTE Date:12/14/98ISR Number: 3170602-1Report Type:Expedited (15-DaCompany Report #970630 Age: Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Death INTRATHECAL Convulsion INTRATHECAL Health Lioresa PS Professional ROUTE Date:12/17/98ISR Number: 3171745-9Report Type:Expedited (15-DaCompany Report #98CDN10565 Age: Gender:Male I/FU:I Outcome Dose Duration Other 7MG ONCE ORAL PT Report Source Product Role Respiratory Arrest Foreign Lioresal PS Manufacturer Route ORAL Health Professional Other Date:12/21/98ISR Number: 3172394-9Report Type:Expedited (15-DaCompany Report #98F--11034 Age:58 YR Gender:Male I/FU:F Outcome Dose Duration Life-Threatening 30 MG DAILY PT Report Source Product Role Manufacturer Route Conduction Disorder Foreign Lioresal (Baclofen) PS ORAL Left Ventricular Failure Health Myocardial Infarction Professional Tenormine (Atenolol) SS ORAL Ventricular Tachycardia Other Dantrium (Dantrolene Sodium) SS ORAL Lexomil Ditropan Fonzylane C C C ORAL 100 MG DAILY ORAL 50 MG DAILY ORAL 22-Aug-2005 Page: 34 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/05/99ISR Number: 3176750-4Report Type:Direct Age:84 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 10MG QD Initial or Prolonged PT Company Report # Report Source Sedation Product Role Baclofen PS Procan Sr Coumadin Dig Perd Colace Premarine Provera Fosomax Zantac C C C C C C C C Manufacturer Route Manufacturer Route Date:01/05/99ISR Number: 3192864-7Report Type:Expedited (15-DaCompany Report #ZANA0319990441 Age:1 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PER ORAL PT Report Source Product Role Rectal Prolapse Foreign Health Ternelin (Tizanidine Hydrochloride) PS Professional Distributor Lioresal (Baclofen) Phenobal Erythromycin Baktar Biothree Millact Phenobal Erythromycin Baktar Biothree Millact Mucodyne Leftose Bisolvone Zaditen SS C C C C C C C C C C C C C C Date:01/07/99ISR Number: 3177760-3Report Type:Expedited (15-DaCompany Report #98-10-0239 Age:48 YR Gender:Female I/FU:F ORAL Outcome Dose Duration Hospitalization Initial or Prolonged 10MG BID ORAL PT Report Source Product Role Manufacturer Route Aphasia Bladder Disorder Consumer Baclofen PS Zenith Goldline Pharm. ORAL Manufacturer Route Eyelid Disorder Faecal Incontinence Feeling Abnormal Hearing Impaired Irritable Bowel Syndrome Paralysis Darvocet-N Arthotec C C Date:01/07/99ISR Number: 3178238-3Report Type:Expedited (15-DaCompany Report #111395 Age:35 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Blood Bilirubin Increased Cholestasis Jaundice Foreign Health Professional Rivotril (Clonazepam) 2.5 Mg/Ml PS ORAL Pruritus Other Azantac (Ranitidine) SS ORAL ORAL DAILY ORAL Di-Antalvic (Acetaminophen/Propo 22-Aug-2005 Page: 35 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report xyphene Hydrochloride) SS ORAL Imurel (Azathioprine) SS ORAL Minidril (Ethinyl Estradiol/Levonorges trel) SS ORAL Lioresal (Baclofen) 10 Mg SS ORAL 6 DOSE FORM DAILY ORAL 2 DOSE DORM DIALY ORAL 1 DOSE FORM DAILY ORAL 30 MG DAILY ORAL Date:01/07/99ISR Number: 3179582-6Report Type:Expedited (15-DaCompany Report #98D-11022 Age:12 YR Gender:Female I/FU:F Outcome Dose Other 5MG DIALY ORAL RECTAL RECTAL PT Report Source Product Role Anorexia Foreign Lioresal PS Electrolyte Imbalance Health Klistier (Travad Phosphate Enema) SS Liskantin Tegretal Rivotril Antra C C C C Manufacturer Route Duration 3 DAY Fatigue Hypernatraemia 1 DF, DAILY Hypokalaemia 8 DAY Metabolic Alkalosis Pyrexia Professional Other Date:01/08/99ISR Number: 3179579-6Report Type:Expedited (15-DaCompany Report #99USA10012 Age:18 MON Gender:Male I/FU:I ORAL Outcome Dose Duration Hospitalization DAILY ORAL Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Nephrosclerosis Health Lioresal PS ORAL Nephrotic Syndrome Professional Ibuprofen SS ORAL Scar Date:01/12/99ISR Number: 3180803-4Report Type:Expedited (15-DaCompany Report #99USA10012 Age:18 MON Gender:Male I/FU:F Outcome Dose Duration Hospitalization 20 MG, DAILY, Initial or Prolonged ORAL PT Report Source Product Role Cerebral Palsy Health Lioresal PS ORAL Glomerulonephritis Professional Ibuprofen SS ORAL Hyperbilirubinaemia Manufacturer Route ORAL Kernicterus Nephrosclerosis Nephrotic Syndrome Scar Date:01/21/99ISR Number: 3203026-9Report Type:Expedited (15-DaCompany Report #98F-11092 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL Report Source Product Role Ileus Paralytic Foreign Health Professional Lioresal (Baclofen) Solution For Injection PS 140 MCG DAILY INTRATHECAL 22-Aug-2005 Page: 36 PT 12:15 PM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/99ISR Number: 3387083-5Report Type:Periodic Age:54 YR Gender:Male I/FU:I Outcome Dose Company Report #97USA11985 PT Report Source Product Role Liver Function Test Abnormal Health Professional Lioresal Tablet 10mg (Baclofen) PS Manufacturer Route Duration ORAL 10 MG, TID, ORAL 4 DAY Date:01/21/99ISR Number: 3387088-4Report Type:Periodic Age:78 YR Gender:Male I/FU:I Outcome Dose Company Report #97USA12197 PT Report Source Product Role Confusional State Sedation Health Professional Lioresal Tablet 10 Mg (Baclofen) PS Nitro Diuretics Potassium C C C Manufacturer Route Duration ORAL 10 MG, QID, ORAL Date:01/21/99ISR Number: 3387091-4Report Type:Periodic Age:54 YR Gender:Female I/FU:I Outcome Dose Company Report #98USA10469 PT Report Source Product Role Nasal Oedema Parosmia Health Professional Lioresal Tablet 10 Mg (Baclofen) PS Manufacturer Route Duration ORAL 10 MG, TID, ORAL Date:01/21/99ISR Number: 3387095-1Report Type:Periodic Age:25 YR Gender:Female I/FU:I Outcome Dose PT Duration Company Report #98USA10780 Report Source Product Role Manufacturer Route Blood Prolactin Increased Health Professional Lioresal Tablet (Baclofen) PS ORAL DAILY, ORAL Date:01/21/99ISR Number: 3387097-5Report Type:Periodic Age:55 YR Gender:Male I/FU:I Outcome Dose Company Report #98USA10779 PT Report Source Product Role Abnormal Faeces Health Professional Lioresal Tablet 5mg (Baclofen) PS Manufacturer Route Duration ORAL 5 MG, TID, ORAL Date:01/21/99ISR Number: 3387100-2Report Type:Periodic Age:23 YR Gender:Male I/FU:I Outcome Dose PT Report Source Product Role Dystonia Eye Movement Disorder Health Professional Lioresal Tablet (Baclofen) PS Manufacturer Route Duration DAILY, ORAL Hyperhidrosis Pain 22-Aug-2005 Page: 37 Company Report #98USA10794 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/99ISR Number: 3387102-6Report Type:Periodic Age:72 YR Gender:Female I/FU:I Outcome Dose Company Report #98USA11248 PT Report Source Product Role Pollakiuria Consumer Lioresal Tablet 20mg (Baclofen) PS Imipramine Tablet Diflucan Zantac C C C Manufacturer Route Duration ORAL 20 MG, QD, ORAL Date:01/21/99ISR Number: 3387103-8Report Type:Periodic Age:65 YR Gender:Female I/FU:I Outcome Dose Company Report #98USA11305 PT Report Source Product Role Sedation Health Professional Lioresal Tablet 10 Mg (Baclofen) PS Manufacturer Route Manufacturer Route Duration 10 MG, BID, ORAL Date:01/21/99ISR Number: 3387107-5Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #98USA11316 PT Report Source Product Role Dystonia Health Professional Lioresal Tablet (Baclofen) PS Duration ORAL DAILY, ORAL Date:01/21/99ISR Number: 3387108-7Report Type:Periodic Age:43 YR Gender:Female I/FU:I Outcome Dose Company Report #98USA11326 PT Report Source Product Drug Ineffective Health Lioresal Tablet Duration Role Manufacturer Route Loss Of Libido Professional (Baclofen) PS Betaseron C ORAL DAILY, ORAL Date:01/21/99ISR Number: 3387111-7Report Type:Periodic Age:23 YR Gender:Male I/FU:I Outcome Dose Company Report #98USA11375 PT Report Source Product Role Liver Function Test Abnormal Health Professional Lioresal Tablet 20 Mg (Baclofen) PS Compazine Solution For Injection Amitriptyline Tablet Carafate Tablet Zanaflex Tablet Amitriptyline Tablet Motrin Tablet Ultram Tablet C C C C C C C Manufacturer Route Duration ORAL 20 MG, TID, ORAL Date:01/21/99ISR Number: 3387112-9Report Type:Periodic Age:48 YR Gender:Male I/FU:I Outcome Dose DAILY, ORAL 22-Aug-2005 Page: 38 Company Report #97USA12443 PT Report Source Product Role Hepatitis Health Professional Baclofen Tablet Unknown (Baclofen) PS Other Tizanidine Manufacturer Route Duration 7 DAY 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrochloride (Tizanidine Hydrochloride) SS Prozac Wellbutrin C C ORAL ORAL Date:01/21/99ISR Number: 3387114-2Report Type:Periodic Age:47 YR Gender:Male I/FU:I Outcome Dose Company Report #98USA10706 PT Report Source Product Role Convulsion Hallucination Health Professional Baclofen Tablet (Baclofen) PS Ditropan C Manufacturer Route Manufacturer Route Duration DAILY Date:01/21/99ISR Number: 3387117-8Report Type:Periodic Age:6 YR Gender:Male I/FU:I Outcome Dose Company Report #98USA10945 PT Report Source Product Role Haematuria Health Professional Baclofen Tablet (Baclofen) PS Duration ORAL DAILY, ORAL Date:01/21/99ISR Number: 3387120-8Report Type:Periodic Age:52 YR Gender:Female I/FU:I Outcome Dose Company Report #98USA11428 PT Report Source Product Role Nocturia Pollakiuria Health Professional Baclofen Tablet 20 Mg (Baclofen) PS Valium Tablet Ditropan Tablet Na C C C Manufacturer Route Duration 20 MG, TID, Urinary Incontinence ORAL ORAL Date:01/21/99ISR Number: 3387123-3Report Type:Periodic Age:42 YR Gender:Male I/FU:I Outcome Dose Company Report #98USA11708 PT Report Source Product Role Abnormal Behaviour Lethargy Health Professional Baclofen Tablet (Baclofen) PS Remeron Tablet Prilosec Tablet Valium Tablet C C C Manufacturer Route Duration ORAL DAILY, ORAL Tongue Disorder Date:01/22/99ISR Number: 3384582-7Report Type:Periodic Age:60 YR Gender:Male I/FU:I Outcome Dose Company Report #R98-017 PT Report Source Product Role Manufacturer Coordination Abnormal Health Professional Baclofen Tablets, (Strength Unknown) Watson, Miami PS Watson, Miami Procardia Xl Cardura Zoloft Leukeran Nephrovit Qd Quinidine Ambien C C C C C C C Duration 1/2 (10 MG TID) 22-Aug-2005 Page: 39 2 DAY 12:15 PM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ticlid Date:01/22/99ISR Number: 3384588-8Report Type:Periodic Age:39 YR Gender:Male I/FU:I Outcome Dose C Company Report #R98-024 PT Report Source Product Role Manufacturer Paraesthesia Health Professional Baclofen Tablets, 10 Mg, Watson Laboratories, Miami Div. PS Watson Laboratories, Miami Div. Route Duration 10 MG TID Date:01/22/99ISR Number: 3384592-XReport Type:Periodic Age:46 YR Gender:Female I/FU:I Outcome Dose Company Report #R98-057 PT Report Source Product Role Manufacturer Drug Ineffective Consumer Baclofen Tablets, 10 Mg, Watson Miami PS Watson Miami Route Duration QHS Ridaura Naprosyn Seldane Potassium Methotrexate Leucovorin Oral Contraceptive (Ortho Novum 777) Prednisone Date:01/22/99ISR Number: 3384594-3Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose C C C C C C C C Company Report #R98-065 PT Report Source Product Role Manufacturer Dermatitis Hypoaesthesia Consumer Baclofen Tablets, 10 Mg, Watson Miami PS Watson Miami Duration 1QAM, 1 NOON, Route 1/2 QPM, 1/2 QHS Valium 80 Mg Darvon-N Date:01/22/99ISR Number: 3384595-5Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose C C Company Report #R98-067 PT Report Source Product Role Manufacturer Chronic Fatigue Syndrome Epistaxis Health Professional Baclofen Tablets, 10 Mg, Watson Miami PS Watson Miami Duration 1 OD (1/2 Eye Haemorrhage TAB) Vaginal Haemorrhage 22-Aug-2005 Page: 40 12:15 PM Chlortrimeton Qd Entex Berroca Plus Qd V &C 500 Mg (Ester-C) Qd Locithin Qd Vitamin E (Several X/Week) Zinc Prn Betacarotene (Prn) Garlic (Prn) Siberian Ginseng C C C C C C C C C Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ginger Tea W/Licorice Root C Date:01/25/99ISR Number: 3185447-6Report Type:Expedited (15-DaCompany Report #99USA10036 Age:46 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization DAILY , ORAL Initial or Prolonged PT Report Source Product Role Accidental Overdose Health Baclofen PS Aggression Drug Ineffective Medication Error Professional Manufacturer Route ORAL Date:01/25/99ISR Number: 3185448-8Report Type:Expedited (15-DaCompany Report #99USA10037 Age:40 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 10 MG , Q8H, Initial or Prolonged ORAL PT Report Source Product Role Gastrointestinal Health Lioresal PS Obstruction Professional Dilantin Synthroid C C Peritonitis Sepsis Date:01/26/99ISR Number: 3194364-7Report Type:Periodic Age:44 YR Gender:Male I/FU:F Outcome Dose Other 50 MG TOTAL Manufacturer Route ORAL Company Report #9830427 PT Report Source Product Role Manufacturer Route Drug Ineffective Consumer Viagra Tablets PS ORAL Erectile Dysfunction Health Baclofen SS ORAL Betaseron Amantidine Desyrel C C C Duration PRN ORAL Professional ORAL Date:01/27/99ISR Number: 3186838-XReport Type:Expedited (15-DaCompany Report #B043818 Age:40 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 300 MG QD Initial or Prolonged ORAL PT Report Source Product Role Epilepsy Foreign Videx PS Professional Baclofen SS Other Bactrim Forte Viracept Viramune .. .. .. .. .. C C C C C C C C Health 30 MG QD Date:01/28/99ISR Number: 3187763-0Report Type:Expedited (15-DaCompany Report #R98-068 Age:49 YR Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 41 12:15 PM PT Appetite Disorder Convulsion Difficulty In Walking Disturbance In Attention Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Medication Error Nausea Sedation Dose Report Source Product Role Manufacturer Consumer Other Baclofen PS Watson Labs, Div. Amantidine C Route Duration Miami 2 QID TABLETS Date:01/29/99ISR Number: 3188604-8Report Type:Expedited (15-DaCompany Report #98J-10423 Age:12 MON Gender: I/FU:F Outcome Dose PT Report Source Product Role Manufacturer Route Rectal Prolapse Foreign Lioresal Unknown (Baclofen) PS ORAL Ternelin Unknown (Tizanidine) SS ORAL Duration 5 MG, DAILY, ORAL 1 MG, DAILY, ORAL Date:01/29/99ISR Number: 3199029-3Report Type:Periodic Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Hypotonia Initial or Prolonged Paraesthesia INTRATHECAL 140 MCG/DAY Spinal Disorder Date:02/01/99ISR Number: 3188925-9Report Type:Direct Age:47 YR Gender:Male I/FU:I Outcome Dose PT Duration Company Report #990637 Report Source Product Role Consumer Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Company Report # Report Source Product Role Hospitalization INTRATHECAL IT Initial or Prolonged Respiratory Distress Health Vomiting Professional Date:02/08/99ISR Number: 3198526-4Report Type:Direct Age:51 YR Gender: I/FU:I Outcome Dose Duration Hospitalization 10MG PO Initial or Prolonged PT Baclofen Company Report # Report Source Product Role Coordination Abnormal Baclofen 10mg PS Dysarthria Insomnia Sedation Tremor Humulin L Colace Qd Niferex Forte Ecasa Coumadin Nephrocaps Nahco3 Phoslo Catapress Synthroid C C C C C C C C C C Date:02/16/99ISR Number: 3199725-8Report Type:Expedited (15-DaCompany Report #99F-10094 Age:35 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 42 12:15 PM PS PT Blood Bilirubin Increased Hepatic Function Abnormal Hepatitis Cholestatic Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Jaundice Pruritus Dose Report Source Product Role Manufacturer Route Foreign Health Lioresal Tablet (Baclofen) PS ORAL Imurel Tablet (Azathioprine) SS ORAL Di-Antalvic Capsule (Aporex) SS ORAL Rivotril Solution (Clonazepam) SS ORAL Minidril Tablet (Neovlar 21) SS ORAL Azantac Unknown (Ranitidine Hydrochloride) SS ORAL Duration 30 MG, DAILY, Professional ORAL 12 MON Other 100 MG, DAILY, ORAL 9 YR 6 DF, DAILY, ORAL ORAL 1 DF, DAILY, ORAL 1 DF, DAILY, ORAL 7 MON Date:02/17/99ISR Number: 3200636-XReport Type:Expedited (15-DaCompany Report #98D--10901 Age:30 YR Gender:Female I/FU:I Outcome PT Dose Duration Life-Threatening Condition Aggravated INTRATHECAL DAILY, Dysphagia INTRATHEKAL Paralysis Flaccid Quadriplegia Report Source Product Role Foreign Lioresal Solution PS Bactrim Mylepsinum C C Health Professional Manufacturer Route Akatinol Memantine C Date:02/17/99ISR Number: 3200643-7Report Type:Expedited (15-DaCompany Report #990645 Age: Gender:Female I/FU:I Outcome PT Dose Duration Life-Threatening Dysphagia INTRATHECAL DAILY, Paralysis Flaccid INTRATHECAL Paresis Quadriplegia Report Source Product Role Health Lioresal PS Manufacturer Route Manufacturer Route Professional Date:02/18/99ISR Number: 3203378-XReport Type:Expedited (15-DaCompany Report #99USA10036 Age:46 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG, PT Report Source Product Role Accidental Overdose Aggression Health Professional Baclofen Tablet 10 Mg (Baclofen) PS ORAL Confusional State DAILY, ORAL Convulsion Drug Ineffective Date:02/19/99ISR Number: 3203023-3Report Type:Expedited (15-DaCompany Report #990633 Age: Gender:Not SpecifiI/FU:I Outcome PT Dose Duration Hospitalization Spastic Paralysis Initial or Prolonged INTRATHECAL 140 MCG, 22-Aug-2005 Page: 43 12:15 PM Report Source Product Role Other Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAILY, INTRATHECAL Date:02/25/99ISR Number: 3208015-6Report Type:Expedited (15-DaCompany Report #200701 Age:13 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged 10 DOSE FORM PT Report Source Product Role Manufacturer Route Confusional State Foreign Naproxen (Naproxen) PS ORAL Illusion Other Baclofen (Baclofen) SS ORAL Overdose ORAL Psychotic Disorder Date:02/25/99ISR Number: 3211358-3Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other 50.00 MG Company Report #9805405 PT Report Source Product Role Drug Dependence Consumer Zoloft Tablets PS Baclofen Ambien Provera Climara SS SS C C Manufacturer Route Duration ORAL Hypertonia TOTAL;DAILY;O Influenza Like Illness RAL Insomnia Date:03/05/99ISR Number: 3212283-4Report Type:Direct Age:11 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Medication Error INTRATHECAL 385 MCG/DAY Company Report # Report Source Product Role Baclofen PS Manufacturer Route Initial or Prolonged INTRATHECAL Date:03/15/99ISR Number: 3220879-9Report Type:Expedited (15-DaCompany Report #99USA10037 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 10 MG, Q8H, PT Report Source Product Role Gastrointestinal Obstruction Health Professional Lioresal Tablet 10 Mg (Baclofen) PS Dilantin Tablet Synthroid Tablet C C Manufacturer Route ORAL Peritonitis ORAL Sepsis Date:03/16/99ISR Number: 3222091-6Report Type:Expedited (15-DaCompany Report #001-0945-990140 Age:55 YR Gender:Female I/FU:I Outcome Dose Duration Death Hospitalization 900 MG (300 Initial or Prolonged MG, TID) PT Report Source Product Role Drug Interaction Hepatic Necrosis Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Hepatotoxicity Multi-Organ Failure 22-Aug-2005 Page: 44 12:15 PM (Ciclosporin) (Azathioprine) (Prednisone) (Ranitidine) (Baclofen) (Atorvastatin) (Ketoconazole) Acetaminophen (Paracetamol) SS SS SS SS SS SS SS SS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Niacin (Nicotinic Acid) Dilaudid (Hydromorphone Hydrochloride) (Alprazolam) (Losartan) (Atenolol) (Diltiazem) Date:03/19/99ISR Number: 3223446-6Report Type:Periodic Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Ileus Paralytic Initial or Prolonged Other INTRATHECAL 140 MCG, SS SS SS SS SS C Company Report #98F--11092 Report Source Product Role Foreign Health Professional Lioresal Solution For Injection (Baclofen) PS Lioresal Tablet (Baclofen) SS Manufacturer Route Other DAILY, INTRATHECAL ORAL ORAL Date:03/19/99ISR Number: 3223690-8Report Type:Expedited (15-DaCompany Report #98J--10368 Age:63 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 10 MG ONCE PT Report Source Product Role Asthenia Depressed Level Of Foreign Health Lioresal Tablet (Baclofen) PS Consciousness Professional Calcium Carbonate Tegretol Zantac Landesen Lendormin Norvasc C C C C C C ORAL Disorientation Dry Mouth Insomnia Sedation Manufacturer Route ORAL Imidapril C Date:04/06/99ISR Number: 3234694-3Report Type:Expedited (15-DaCompany Report #99GB-10214 Age:13 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization DAILY, ORAL Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Confusional State Foreign Baclofen PS ORAL Hallucination Health Naproxen SS ORAL Illusion Intentional Misuse Psychotic Disorder Professional Other Date:04/09/99ISR Number: 3236615-6Report Type:Expedited (15-DaCompany Report #99USA10387 Age:47 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged DAILY, ORAL 22-Aug-2005 Page: 45 12:15 PM PT Report Source Product Role Ileus Paralytic Health Professional Lioresal Tablet (Baclofen) PS Ditropan Reglan Megace C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/12/99ISR Number: 3238057-6Report Type:Expedited (15-DaCompany Report #98D-11022 Age:14 YR Gender:Female I/FU:F Outcome PT Dose Duration Life-Threatening Anorexia 5 MG DAILY, Hospitalization Apathy ORAL 3 DAY Initial or Prolonged Electrolyte Imbalance RECTAL 1 DF, DAILY, Other Fatigue RECTAL 8 DAY Gastrooesophageal Reflux Disease Hypernatraemia Hypokalaemia Metabolic Alkalosis Oral Intake Reduced Pyrexia Screaming Report Source Product Health Lioresal PT (Baclofen) Manufacturer PS Route ORAL Professional Other Date:04/14/99ISR Number: 4515941-4Report Type:Direct Age:70 YR Gender:Male I/FU:I Outcome Dose Role Travad SS Rivotril Antra C C Company Report #USP 52243 Report Source Product Role Manufacturer Gastrointestinal Baclofen PS Goldline Haemorrhage Lotensin SS Novartis Role Manufacturer Route Duration TABLET TABLET Haemorrhage Medication Error Myocardial Infarction Date:04/22/99ISR Number: 3244511-3Report Type:Direct Age:70 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Company Report # PT Report Source Product Encephalopathy Health Baclofen Route PS ORAL Hospitalization Multiple Sclerosis 300MG MWF 10 DAY Initial or Prolonged Respiratory Acidosis Sepsis 10 MG PO TID 2 Professional Date:04/22/99ISR Number: 3244513-7Report Type:Direct Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 10 MG BID PRN Hospitalization BUT PATIENT Initial or Prolonged ONLY TOOK 3 3 Synthroid Colace Phos-Lo Nephron Caps Cortisone Senokot Prevacid Restoril Ventolin Atrovent Calcitonin Vicodin C C C C C C C C C C C C Company Report # Product Role Aphasia Health Baclofen PS Confusional State Professional Encephalopathy DAY 12:15 PM SS Report Source Mental Impairment 22-Aug-2005 Page: 46 Neurontin PT Grand Mal Convulsion PILLS TOTAL DAY Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/23/99ISR Number: 3245793-4Report Type:Expedited (15-DaCompany Report #B0064757 Age:7 YR Gender:Male I/FU:F Outcome Dose Duration Life-Threatening 30 MG/KG / Hospitalization THREE TIMES Initial or Prolonged PER / Other INTRAGASTRIC PT Report Source Product Role Blood Creatinine Foreign Zinacef PS Increased Health Blood Urea Increased Professional Vigabatrin SS Baclofen SS Cephalexin SS Carbamazepine SS Dehydration Drug Toxicity 750 MG/KG / Hepatocellular Damage TWICE PER Hypernatraemia DAY/ Renal Failure Acute INTRAGASTRIC 5 G / THREE TIMES PER DAY / INTRAGASTRIC 250 MG / TWICE PER DAY / INTRAGASTRIC 300 MG / TWICE PER DAY / INTRAGASTRIC Manufacturer Route Date:04/27/99ISR Number: 3246969-2Report Type:Direct Age: Gender: I/FU:I Outcome Dose PT Company Report # Report Source Product Role Manufacturer Baclofen Lotensin (Benazepril) PS Goldline SS Novartis Role Manufacturer PS C C Watson Labs.,Miami Route Duration Gastrointestinal Haemorrhage Haemorrhage Medication Error Myocardial Infarction Date:04/27/99ISR Number: 3247009-1Report Type:Expedited (15-DaCompany Report #R99-014 Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Convulsion Depressed Level Of Consciousness Health Professional Baclofen Tablets (Strength Unk) Watson Labs.,Miami Megace Tums Norvasc (Prn Hypertension) Synthroid Epogen Ativan Qhs Prozac (Qhs) Route C C C C C Date:04/29/99ISR Number: 3249987-3Report Type:Expedited (15-DaCompany Report #001-0945-990140 Age:55 YR Gender:Female I/FU:F Outcome Dose Duration Death Hospitalization 900 MG (300 Initial or Prolonged MG, TID) PT Report Source Product Role Drug Interaction Hepatic Necrosis Health Professional Neurontin Capsules 300 Mg (Gabapentin) PS Ciclosporin SS Hepatotoxicity Multi-Organ Failure 22-Aug-2005 Page: 47 12:15 PM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Azathioprine Prednisone Losartan Atenolol Diltiazem Ranitidine Alprazolam Baclofen Dilaudid (Hydromorphone Hydrochloride) Atorvastatin Niacin (Nicotinic Acid) Ketoconazole Acetaminophen (Paracetamol) Ambien Aspirin Dicyclomine Lasix Lonox Nizoral Vitamin E Niaspan Erythromycin Tylenol SS SS SS SS SS SS SS SS SS SS SS SS SS C C C C C C C C C C Date:04/30/99ISR Number: 3251124-6Report Type:Expedited (15-DaCompany Report #99HQ-10171 Age:42 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 200 MG DAILY PT Report Source Product Role Agitation Bradycardia Foreign Literature Baclofen Unknown (Baclofen) PS Coma Health Confusional State Cough Delirium Disorientation Drug Withdrawal Syndrome Dysarthria Haemodialysis Professional ORAL Manufacturer Route ORAL Hallucination Hyporeflexia Hypotension Hypotonia Insomnia Loss Of Consciousness Lung Infiltration Pyrexia Respiratory Depression Simple Partial Seizures Date:05/03/99ISR Number: 3252140-0Report Type:Expedited (15-DaCompany Report #990665 Age: Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 48 12:15 PM PT Csf White Blood Cell Count Positive FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Meningitis Pyrexia Dose Report Source Product Role Health Professional Lioresal (R) Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route Duration INTRATHECAL UNK, DAILY, INTRATHECAL Date:05/03/99ISR Number: 3252141-2Report Type:Expedited (15-DaCompany Report #990665 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL PT Csf Culture Positive Mechanical Complication Of Implant UNK, DAILY, Meningitis Report Source Product Role Health Professional Lioresal (R) Intrathecal (Baclofen Injection) PS INTRATHECAL Pyrexia Date:05/03/99ISR Number: 3252629-4Report Type:Expedited (15-DaCompany Report #98--D10338 Age:61 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 75 MG, DAILY, PT Report Source Product Role Asthma Condition Aggravated Foreign Health Lioresal Tablet (Baclofen) PS Drug Interaction Professional Theophyllin Unknown (Theophyllin) SS Catapressan (Clonidine Hydrochloride) SS ORAL 200 MG, DAILY ORAL Date:05/04/99ISR Number: 3256747-6Report Type:Expedited (15-DaCompany Report #99F--10373 Age:62 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 5 MG, DAILY,ORAL 6 PT Report Source Product Role Manufacturer Route Encephalopathy Personality Change Due To Foreign Health Lioresal Tablet (Baclofen) PS ORAL A General Medical Professional Condition Other Rifadine Capsule (Rifampicin) SS ORAL Inh Tablet (Isoniazid) SS ORAL Rimifon Tablet (Isoniazid) SS ORAL Amlor Capsule Triatec Tablet C C DAY ORAL ORAL ORAL Date:05/07/99ISR Number: 3256703-8Report Type:Expedited (15-DaCompany Report #99USA10488 Age:30 MON Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 49 12:15 PM PT Condition Aggravated Muscle Rigidity Neutrophil Count Increased Pyrexia Staphylococcal Sepsis FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report White Blood Cell Count Increased Dose Report Source Product Role Health Professional Baclofen Tablet 5 Mg (Baclofen) PS Amphotericin B Solution For Infusio Ceftazidime Clindamycin Tylenol Benadryl Lactinex Nystatin C C C C C C C Manufacturer Route Manufacturer Route Duration INTRATHECAL 5 MG, TID, GASTRIC DRIP Date:05/17/99ISR Number: 3264030-8Report Type:Expedited (15-DaCompany Report #8-99130-093A Age: Gender: I/FU:I Outcome Dose Other PT Report Source Product Role Respiratory Arrest Foreign Health Professional Efexor Tablets ( Venlafaxine Hydrochloride ) PS ORAL Baclofen Tablets SS ORAL Temazepam Unspecified Medications SS Duration ORAL ORAL C Date:05/19/99ISR Number: 3265938-XReport Type:Expedited (15-DaCompany Report #G99-245 (99F-10373) Age:62 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 5 MG DAILY ORAL 6 DAY PT Report Source Product Role Coma Confusional State Foreign Health Lioresal Tablet (Baclofen) PS Electroencephalogram Professional Manufacturer Route ORAL Abnormal Encephalopathy Other Rifadine Capsules (Rifampicin) SS ORAL Overdose Personality Change Due To Inh Tablet (Isoniazid) SS ORAL A General Medical Condition Rimifan Tablet (Isoniazide) SS ORAL Amlor Capsule Triatec Tablet C C ORAL ORAL ORAL Date:05/19/99ISR Number: 3330432-4Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Company Report #5833/20771 PT Report Source Product Role Pain Consumer Company Representative Detrol Tablets Baclofen PS SS Date:05/20/99ISR Number: 3265117-6Report Type:Expedited (15-DaCompany Report #99-05-0121 Age:70 YR Gender:Male I/FU:I Outcome Death Hospitalization 22-Aug-2005 Page: 50 Manufacturer Route Duration 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Dose PT Report Source Product Role Manufacturer Route Encephalopathy Health Baclofen Tablets PS ORAL Multiple Sclerosis Professional Neurontin Tablets SS ORAL Synthroid Colace Nephrocaps Cortisone Senokot Prevacid Restoril Ventolin Vicodin Atrovent Calcitonin C C C C C C C C C C C Duration 10MG TID ORAL 300MG MWF Respiratory Acidosis ORAL Sepsis Date:05/20/99ISR Number: 3265118-8Report Type:Expedited (15-DaCompany Report #99-05-0122 Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Grand Mal Convulsion Mental Impairment Speech Disorder Health Professional Baclofen - Zenith Goldline Pharm. Tablets PS Zenith Goldline Pharm. ORAL Manufacturer Route 10MG BID ORAL Date:05/21/99ISR Number: 3268966-3Report Type:Direct Age:39 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization DAILY Initial or Prolonged Disability Company Report # PT Report Source Product Role Hypersensitivity Malaise Health Professional Propulsid 10mg & Premarin 0.625mg PS Mechanical Complication Of Implant Premarin Baclofen 10mg & SS Required Intervention to Prevent Permanent Impairment/Damage Tynelos Extract Str Tynelo Extract Str Steffe Stainless Stell Plates + Screws SS SS C Date:05/24/99ISR Number: 3269151-1Report Type:Expedited (15-DaCompany Report #99USA10565 Age: Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization DAILY, ORAL Initial or Prolonged PT Report Source Product Role Coma Haemodialysis Health Professional Lioresal Tablet (Baclofen) PS Manufacturer Route ORAL Hypothermia Overdose Respiratory Failure Date:05/26/99ISR Number: 3269925-7Report Type:Expedited (15-DaCompany Report # Age: Gender: I/FU:I Outcome Dose Other 22-Aug-2005 Page: 51 PT Report Source Product Overdose Health Professional Baclofen (Unknown Strenght) Watson Duration 12:15 PM Role Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Laboratories. Miami PS Watson Laboratories Manufacturer Date:05/27/99ISR Number: 3271184-6Report Type:Expedited (15-DaCompany Report #001-0945-990421 Age:70 YR Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Role Back Pain Encephalopathy Health Professional Neurontin (Gabapentin) PS (Baclofen) SS Route Duration 300 MG ON Liver Function Test MON, WED & Abnormal FRI, UNKNOWN Mental Impairment 30 MG (10 MG, Respiratory Acidosis TID) PER ORAL Sepsis Colace (Docusate Sodium) Phoslo (Calcium Acetate) (Cortisone) Nephrocaps (Folic Acid, Vitamins Nos) Prevacid (Lansoprazole) Restoril (Temazepam) (Calcitonin) Vicodin (Paracetamol, Hydrocodone Bitartrate) Senokot (Senna Fruit) Ventolin (Salbutamol) Atrovent (Ipratropium Bromide) Synthroid (Levothyroxine Sodium) Cordarone (Amiodarone Hydrochloride) C C C C C C C C C C C C C ORAL Date:06/01/99ISR Number: 3274301-7Report Type:Expedited (15-DaCompany Report #99GB-10342 Age: Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Role Complications Of Maternal Exposure To Therapeutic Foreign Health Lioresal Unknown (Baclofen) PS Drugs Convulsion Neonatal Drug Withdrawal Convulsions Professional Other Duration DAILY Date:06/01/99ISR Number: 3274347-9Report Type:Expedited (15-DaCompany Report #99F-10446 Age:75 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 52 12:15 PM PT Agitation Confusional State Medication Error Report Source Foreign Health Professional Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Dose Product Role Manufacturer Route Lioresal Tablet (Baclofen) PS ORAL Topalgic Capsule (Tramadol Hydrochloride) SS ORAL Lipur Tablet Stilnox Tablet Spasfon Unknown C C C Duration 15 MG, DAILY, ORAL 12 DAY 300 MG, DAILY, ORAL 10 WK Date:06/02/99ISR Number: 3274552-1Report Type:Expedited (15-DaCompany Report #99-05-0121 Age:70 YR Gender:Male I/FU:F Outcome Dose Duration Death 10MG TID ORAL Hospitalization 300MG MWF Initial or Prolonged ORAL PT Report Source Product Role Encephalopathy Health Baclofen Tablets PS ORAL Mental Impairment Professional Neurontin Tablets SS ORAL Synthroid Colace Nephrocaps Cortisone Senokot Prevacid Restoril Ventolin Vicodin Atrovent Calcitonin C C C C C C C C C C C Respiratory Acidosis Sepsis Manufacturer Route Date:06/07/99ISR Number: 3277800-7Report Type:Expedited (15-DaCompany Report #99F--10373 Age:65 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 5 MG, DAILY, ORAL 6 PT Report Source Product Role Coma Confusional State Foreign Health Lioresal Tablet (Baclofen) PS Dialysis Professional Rifadine Capsule Mopral Capsule Amlor Capsule Inh Tablet Pirilene Tablet Triatec Tablet Fozitec Tablet C C C C C C C Route ORAL DAY Electroencephalogram Abnormal Encephalopathy Personality Change Due To A General Medical Condition Date:06/09/99ISR Number: 3279012-XReport Type:Direct Age:56 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 25MG PO Q 6H Initial or Prolonged 300MG PO TID PT 12:15 PM Company Report # Product Role Accident At Home Baclofen PS Fall Gabapentin SS Sedation 22-Aug-2005 Page: 53 Manufacturer Report Source Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/09/99ISR Number: 3279224-5Report Type:Expedited (15-DaCompany Report #207195 Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PER ONE DOSE PT Report Source Product Role Manufacturer Route Depression Dyspnoea Health Professional Valium Tablets (Diazepam) PS ORAL Baclofen (Baclofen) SS ORAL Ativan (Lorazepam) SS ORAL Glyburide (Glyburide) SS ORAL Glatiramer Acetate (Glatiramer Acetate) SS Trazodone (Trazodone Hydrochloride) SS Doxazosin Mesilate Fosinopril Sodium Naproxen C C C Intentional Misuse ORAL Lethargy PER ONE DOSE Suicide Attempt ORAL 1 PER ONE DOSE ORAL 1 PER ONE DOSE ORAL SUBCUTANEOUS SUBCUTANEOUS 20 MG DAILY 56 DAY ORAL 1 PER ONE DOSE ORAL Date:06/10/99ISR Number: 3280430-4Report Type:Expedited (15-DaCompany Report #99GB-10355 Age: Gender:Male I/FU:I Outcome Dose Other DAILY PT Report Source Product Role Complications Of Maternal Exposure To Therapeutic Foreign Health Baclofen Unknown (Balcofen) PS Duration Manufacturer Route Drugs Premature Baby Professional Other Hydrocortisone Unknown (Hydrocortisone) Tylex Unknown (Paracetamol + Codeine) SS SS Date:06/11/99ISR Number: 3281482-8Report Type:Expedited (15-DaCompany Report #685/9866 Age: Gender:Female I/FU:I Outcome Dose PT Report Source Product Role Intraventricular Haemorrhage Foreign Consumer Company Representative Solu-Cortef Sterile Powder Codeine Phosphate Baclofen PS SS SS Manufacturer Route Manufacturer Route Duration Date:06/11/99ISR Number: 3281491-9Report Type:Expedited (15-DaCompany Report #1895/17498 Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged Other Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 54 12:15 PM PT Report Source Product Role Dyspnoea Consumer Micronase Tablets PS Baclofen Ativan Valium Trazadone Copaxone SS SS SS SS C Intentional Misuse Lethargy Suicide Attempt ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/14/99ISR Number: 3282275-8Report Type:Expedited (15-DaCompany Report #WAES 99065034 Age: Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Intraventricular Haemorrhage Foreign Tab Hydrocortone (Hydrocortisone) Codeine Baclofen PS SS SS Manufacturer Route Duration ORAL Date:06/14/99ISR Number: 3282517-9Report Type:Expedited (15-DaCompany Report #99GB-10361 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Foreign Health Baclofen Unknown (Baclofen) PS Hydrocortisone Unknown (Hydrocortisone) SS Codeine Phosphate Unknown (Codeine Phosphate) SS Duration TRANSPLACENTAL Complications Of Maternal Exposure To Therapeutic UNK, DAILY, Drugs Professional TRANSPLACENTA Intraventricular Other L Haemorrhage Neonatal Premature Baby TRANSPLACENTAL UNK, UNK, TRANSPLACENTA L TRANSPLACENTAL UNK, UNK, TRANSPLACENTA L Date:06/14/99ISR Number: 3282551-9Report Type:Expedited (15-DaCompany Report #WAES 99065034 Age: Gender:Female I/FU:I Manufacturer Route Outcome Dose Duration Life-Threatening Other PO PT Report Source Product Role Intraventricular Haemorrhage Foreign Company Tab Hydrocortone (Hydrocortisone) PS Representative Codeine Baclofen SS SS Manufacturer Route ORAL Date:06/21/99ISR Number: 3288113-1Report Type:Expedited (15-DaCompany Report #99F--10510 Age:34 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 10 MG, BID, PT Report Source Product Role Manufacturer Route Mouth Ulceration Foreign Health Lioresal Tablet (Baclofen) PS ORAL Brexin Tablet (Piroxicam Beta Cyclodextrin) SS ORAL Professional ORAL 40 MG, DAILY, ORAL 14 MON Date:06/22/99ISR Number: 3290028-XReport Type:Expedited (15-DaCompany Report #199912638HMRI Age:51 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Depression PO 1 DAY Initial or Prolonged Dyspnoea Intentional Misuse 1 DAY Lethargy 1 DAY Suicide Attempt 1 DAY 22-Aug-2005 Page: 55 12:15 PM Report Source Product Role Glyburide PS Copaxone Baclofen SS SS Lorazepam SS Diazepam (Valium) SS Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 1 Trazodone SS Doxazosin Mesilate Naproxen Fosinopril C C C DAY Date:06/23/99ISR Number: 3292386-9Report Type:Periodic Age:40 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Dysphagia Initial or Prolonged Headache SUBCUTANEOUS 20 MILLIGRAMS Hypertonia QD Neck Pain SUBCUTANEOUS Company Report #108820USA Report Source Product Role Consumer Copaxone (Glatiramer Acetate) PS Baclofen Neurontin Baclofen Zanaflex Prevacid Prozac Voltaren Macrodantin Detrol Demerol SS C C C C C C C C C Manufacturer Route Route Date:06/25/99ISR Number: 3291427-2Report Type:Expedited (15-DaCompany Report #R99-036 Age:67 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 10 MG BID PT Report Source Product Role Manufacturer Delusion Hallucination Health Professional Baclofen Tablets, 10 Mg. Watson Labs. PS Watson Labs Sodium Bicarbonate Lasix Zithromax Ativan Lactulose C C C C C Date:06/28/99ISR Number: 3292922-2Report Type:Expedited (15-DaCompany Report #99CDN10339 Age: Gender:Unknown I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged UNK, DAILY, PT Report Source Product Role Overdose Foreign Health Lioresal Tablet (Baclofen) PS Manufacturer Route ORAL Professional ORAL Other Date:06/29/99ISR Number: 3294411-8Report Type:Expedited (15-DaCompany Report #500790 Age:63 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Eosinophilia Foreign Health Professional Dantrium Capsules, Dose Unspecified (Dantrolene Sodium) PS ORAL Lioresal (Baclofen) SS ORAL Tegretol (Carbamazepine) SS ORAL ... C ORAL ORAL 1200 MG DAILY; ORAL 22-Aug-2005 Page: 56 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/30/99ISR Number: 3295119-5Report Type:Expedited (15-DaCompany Report #99F--10561 Age:50 YR Gender:Male I/FU:I Outcome Dose Duration Death Life-Threatening 60 MG, DAILY, PT Report Source Product Role Manufacturer Route Arrhythmia Malaise Foreign Health Lioresal Tablet (Baclofen) PS ORAL Pulmonary Embolism Professional Tanakan Tablet (Ginkgo Tree Leaves Extract) SS ORAL Avonex Solution For Injection (Interferon Beta) SS ORAL Other 120 MG, DAILY, ORAL INTRAMUSCULAR INTRAMUSCULAR Date:06/30/99ISR Number: 3295501-6Report Type:Expedited (15-DaCompany Report #WAES 99065034 Age: Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Haemorrhage Intracranial Haemorrhagic Stroke Foreign Other Tab Hydrocortone (Hydrocortisone) PS Codeine Baclofen SS SS Manufacturer Route Duration ORAL PO Intraventricular Haemorrhage Date:07/06/99ISR Number: 3297918-2Report Type:Expedited (15-DaCompany Report #208768 Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Depression Dyspnoea Lethargy Suicide Attempt Other Valium (Diazepam) Glyburide (Glyburide) Baclofen (Baclofen) Ativan (Lorazepam) Trazodone (Trazodone PS SS SS SS Manufacturer Route Hydrochloride) Copaxone (Glatiramer Acetate) Doxazosin Mesilate Naproxen Fosinopril SS SS C C C Date:07/06/99ISR Number: 3298006-1Report Type:Expedited (15-DaCompany Report #99F--10570 Age:60 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 60 MG DAILY PT Report Source Product Role Manufacturer Convulsion Electroencephalogram Foreign Health Lioresal Tablet (Baclofen) PS ORAL Abnormal Professional Bi-Profenid Tablet (Ketoprofen) SS ORAL Anafranil Tablet (Clomipramine Hydrochloride) SS ORAL Topalgic Capsule (Tramadol Hydrochloride) SS ORAL Route ORAL Epilepsy Pain 300 MG Pneumonia DAILY ORAL 4 DAY Pneumonia Aspiration 50 MG DAILY ORAL 300 MG DAILY ORAL 22-Aug-2005 Page: 57 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/06/99ISR Number: 3298147-9Report Type:Expedited (15-DaCompany Report #WAES 99065036 Age: Gender: I/FU:I Outcome Dose Other PT Report Source Product Role Complications Of Maternal Exposure To Therapeutic Foreign Other Tab Hydrocortisone (Hydrocortisone) PS Acetaminophen/Codein e Phosphate Baclofen SS SS Manufacturer Route Duration ORAL PO Drugs Haemorrhage Intracranial Premature Baby Date:07/07/99ISR Number: 3298833-0Report Type:Expedited (15-DaCompany Report #8-99176-137A Age:60 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 150 MG TWICE Initial or Prolonged DAILY ORAL PT Report Source Product Role Blood Creatinine Foreign Orudis (Ketoprofen) PS Increased Health Blood Potassium Increased Convulsion Electroencephalogram Professional Baclofen Clomipramine Hydrochloride SS Manufacturer Route ORAL SS ORAL 50 MG DAILY Abnormal ORAL Pneumonia Aspiration Tramadol Hydrochloride Injection SS 300 MG DOSE Date:07/09/99ISR Number: 3300471-8Report Type:Expedited (15-DaCompany Report #001-0945-990421 Age:70 YR Gender:Male I/FU:F Outcome Dose Death PT Report Source Product Role Alanine Aminotransferase Increased Health Professional Neurontin (Gabapentin) PS Duration 300 MG ON Aspartate MON, WED, & Manufacturer Route Aminotransferase FRI Increased (Baclofen) SS Colace Phoslo Cortisone Nephrocaps Prevacid Restoril (Calcitonin) Vicodin Senokot Ventolin Atrovent Synthroid Cordarone C C C C C C C C C C C C C ORAL 30 MG (10 MG, Encephalopathy TID), PER Mental Impairment ORAL Respiratory Acidosis Sepsis Date:07/12/99ISR Number: 3301916-XReport Type:Expedited (15-DaCompany Report #PRIUSA1999003300 Age:60 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Convulsion Pneumonia Aspiration Foreign Health Professional Ultram (50 Mg Tablet) (Tramadol Hydrochloride) PS ORAL Clomipramine (Clomipramine) SS ORAL 300 MG, DAILY, ORAL 50 MG, ORAL 22-Aug-2005 Page: 58 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ketoprofen (Ketoprofen) SS ORAL Baclofen (Baclofen) SS ORAL Ultram (50 Mg Tablet) (Tramadol Hydrochloride) SS 300 MG , ORAL 60 MG, 1 IN 1 DAILY, ORAL INTRAVENOUS 300 MG, IV Date:07/19/99ISR Number: 3306499-6Report Type:Expedited (15-DaCompany Report #99USA10808 Age:63 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Apallic Syndrome Coma Health Professional Baclofen Tablet 10 Mg (Baclofen) PS Manufacturer Route Duration ORAL 10 MG, BID, ORAL 5 YR Date:07/19/99ISR Number: 3306720-4Report Type:Expedited (15-DaCompany Report #99GB-10342 Age: Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Complications Of Maternal Exposure To Therapeutic Foreign Health Lioresal Unknown (Baclofen) PS Drugs Professional Convulsion Neonatal Drug Withdrawal Syndrome Neonatal Other Duration UNK, DAILY, UNKNOWN Date:08/03/99ISR Number: 3323197-3Report Type:Periodic Age:41 YR Gender:Male I/FU:I Company Report #99-01-0009 Manufacturer Route Outcome Dose Duration Life-Threatening 10MG BID PT Report Source Product Role Drug Withdrawal Syndrome Consumer Baclofen Tablets PS Manufacturer Route ORAL ORAL Date:08/06/99ISR Number: 3320399-7Report Type:Expedited (15-DaCompany Report #19990700899 Age:13 YR Gender:Male I/FU:I Outcome Dose Other EPIDURAL PT Report Source Product Role Foreign Naropin PS Literature Other Baclofen Imipramine SS SS Manufacturer Route Manufacturer Route Duration Acquired Cardiac Septal 20 MG 1 EP Defect Atrioventricular Block Drug Level Above Therapeutic Grand Mal Convulsion Medication Error Tachycardia Date:08/12/99ISR Number: 3324846-6Report Type:Expedited (15-DaCompany Report #99GB-10503 Age:60 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 2.5 MG, Other DAILY, ORAL PT Report Source Product Role Muscular Weakness Respiratory Depression Foreign Health Baclofen Unknown (Baclofen) PS Rifampicin Folic Acid C C Professional Other 22-Aug-2005 Page: 59 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sytron Ciprofloxacin Prozac Teicoplanin Clexane C C C C C Date:08/24/99ISR Number: 3333416-5Report Type:Expedited (15-DaCompany Report #99F--10775 Age:50 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged DAILY, ORAL PT Report Source Product Role Suicide Attempt Toxicologic Test Abnormal Foreign Health Lioresal Tablet (Baclofen) PS Manufacturer Route ORAL Professional Date:08/24/99ISR Number: 3333419-0Report Type:Expedited (15-DaCompany Report #99D-10338 Age:61 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 10 MG, DAILY, PT Report Source Product Role Manufacturer Route Asthma Condition Aggravated Foreign Health Lioresal Tablet (Baclofen) PS ORAL Drug Interaction Professional Sedation Other Theophyllin (Theophylline) SS ORAL Catapressan (Clonidine Hydrochloride) Aponal Zyrtec Bronchoretard Mite Mono-Embolex Euphylong Bronchorcort SS C C C C C C ORAL 200 MG, DAILY, ORAL Date:09/03/99ISR Number: 3341955-6Report Type:Expedited (15-DaCompany Report #500806 Age:38 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Convulsion Drug Level Below Therapeutic Foreign Health Professional Dantrium Capsules, 100mg (Dantrolene Sodium) PS ORAL Floxyfral (Fluvoxamine Maleate) SS ORAL Lioresal (Baclofen) SS ORAL Tegretol (Carbamazepine) SS ORAL Tiapridal (Tiapride) SS ORAL Floxyfral Lioresal Stablon Tegretol Tiapridal C C C C C Manufacturer Route 300 MG DAILY; Medication Error ORAL 100 MG DAILY; ORAL 40 MG DAILY; ORAL 400 MG DAILY; ORAL 200 MG DAILY; ORAL 22-Aug-2005 Page: 60 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/08/99ISR Number: 3343153-9Report Type:Expedited (15-DaCompany Report #214164 Age:48 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 4 DROP DAILY Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Petechiae Foreign Valium (Diazepam) 1% PS ORAL Vascular Purpura Other Lutheran (Chlormadinone Acetate) 5 Mg SS ORAL Depakine (Valproate Sodium) SS ORAL Lioresal (Baclofen) 10 Mg SS ORAL Forlax ( Polyethylene Glycol) 10gram SS ORAL 5 MG DAILY ORAL ORAL 30 MG 3 PER DAY ORAL 30 GRAM DAILY ORAL Date:09/20/99ISR Number: 3352151-0Report Type:Direct Age:50 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 20MG QID PO Initial or Prolonged PT Hallucination Company Report # Report Source Product Role Baclofen PS Mental Impairment Date:09/21/99ISR Number: 3352953-0Report Type:Direct Age:73 YR Gender:Male I/FU:I Company Report # Manufacturer Route ORAL Outcome Dose Duration Hospitalization 30MG QID PO Initial or Prolonged 100MG QID PO PT Report Source Product Role Manufacturer Route Confusional State Baclofen PS ORAL Dyspnoea Dantrolene SS ORAL Hallucination Date:09/23/99ISR Number: 3356209-1Report Type:Expedited (15-DaCompany Report #97F--10835 Age:80 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Agitation Initial or Prolonged Confusional State ORAL 2 DAY Report Source Product Role Foreign Health Lioresal Tablet (Baclofen) PS Manufacturer Route ORAL Professional Other Date:09/27/99ISR Number: 3359188-6Report Type:Expedited (15-DaCompany Report #99D--10869 Age:40 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 100 MG DAILY 22-Aug-2005 Page: 61 12:15 PM PT Report Source Product Role Bacterial Infection Pyrexia Foreign Health Lioresal Unknown (Baclofen) PS Professional Keltican C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/30/99ISR Number: 3361707-0Report Type:Expedited (15-DaCompany Report #99USA11111 Age:40 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 40 MG, ONCE, PT Report Source Product Role Ventricular Tachycardia Health Professional Lioresal Tablet (Baclofen) PS Manufacturer Route ORAL ORAL Date:09/30/99ISR Number: 3362069-5Report Type:Expedited (15-DaCompany Report #99HQ-10414 Age:70 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Convulsion Delirium Foreign Literature Baclofen Unknown (Baclofen) PS ORAL Drug Ineffective Health Loss Of Consciousness Sedation Professional Other Diazepam Unknown (Diazepam) SS ORAL Dantrolene Unknown (Dantrolene) SS ORAL Duration 100 MG DAILY ORAL 20 MG DAILY ORAL 400 MG DAILY ORAL Date:10/01/99ISR Number: 3362835-6Report Type:Expedited (15-DaCompany Report #99F--10832 Age:48 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 30 MG DAILY PT Report Source Product Role Vascular Purpura Foreign Health Lioresal Tablet (Baclofen) PS Professional ORAL Other Luteran Tablet Manufacturer Route ORAL (Chlormadinone Acetate) SS ORAL Depakine Solution (Valproate Sodium) SS ORAL 5 MG DAILY ORAL 1 DF, DAILY ORAL Date:10/14/99ISR Number: 3371020-3Report Type:Direct Age:50 YR Gender:Male I/FU:I Outcome PT Dose Duration Death Sudden Death SUBCUTANEOUS SUBCUTANEOUS 22-Aug-2005 Page: 62 12:15 PM Company Report # Report Source Product Role Health Naltrexone PS Professional Baclofen Dexamethasone Fentanyl Citric Acid/Sodium Citrate Glycopyrrolate Midazolam Octreotide Acetate Trazodone Vercuronium Propofol Nalmefene Ketamine Hcl Clonidine Diazepam Naltrexone Enalapril Maleate SS SS SS SS SS SS SS SS SS SS SS SS C C C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/14/99ISR Number: 3371022-7Report Type:Direct Age:43 YR Gender:Male I/FU:I Outcome PT Dose Duration Death Sudden Death SUBCUTANEOUS SUBCUTANEOUS Company Report # Report Source Product Role Health Naltrexone PS Professional Baclofen Citric Acid/Sodium Citrate Glycopyrrolate Ketamine Hcl Fentanyl Dexamethasone Midazolam Octreotide Acetate Vercuronium Trazodone Propofol Nalmefene Cefazolin Sodium Clonidine Droperidol Metoclopramide Hcl Naloxone Hcl Ondanstetron Hcl SS Manufacturer Route Manufacturer Route SS SS SS SS SS SS SS SS SS SS SS C C C C C C Date:10/15/99ISR Number: 3373864-0Report Type:Expedited (15-DaCompany Report #99CDN10608 Age: Gender:Female I/FU:I Outcome Dose Duration Life-Threatening PT Report Source Product Role Thrombocytopenia White Blood Cell Count Foreign Health Lioresal Tablet (Baclofen) PS Increased Professional Other ORAL ORAL Date:10/19/99ISR Number: 3374904-5Report Type:Direct Age:44 YR Gender:Male I/FU:I Outcome Dose PT Duration Company Report # Report Source Product Role Manufacturer Route Death SUBCUTANEOUS Death Naltrexone PS Baclofen Dexamethasone Fentanyl Citric Acid/Sodium Citrate Glycopyrrolate Midazolam Octreotide Acetate Trazodone Vercuronium Propofol Nalmefene Ketamine Hcl Cefadroxil Cefazolin Sodium Clonidine Naltrexone SS SS SS 1000MG SUBCUTANEOUS 22-Aug-2005 Page: 63 12:15 PM SS SS SS SS SS SS SS SS SS C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/25/99ISR Number: 3382435-1Report Type:Expedited (15-DaCompany Report #99USA11187 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 80 MG, DAILY, PT Report Source Product Role Muscle Twitching Paraesthesia Consumer Lioresal Tablet 20 Mg (Baclofen) PS Manufacturer Route ORAL Peripheral Nerve Injury ORAL Date:11/01/99ISR Number: 3386792-1Report Type:Expedited (15-DaCompany Report #99F--10775 Age:53 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged UNK, DAILY, PT Report Source Product Role Manufacturer Route Bradycardia Coma Foreign Health Lioresal Tablet (Baclofen) PS Hypothermia Professional Lung Disorder Suicide Attempt Other Theralene Drpos (Alimemazine Tartrate) SS Lysanxia Tablet (Prazepam) SS ORAL Tegretol Tablet (Carbamazepine) SS ORAL Athymil Tablet (Mianserin Hydrochloride) SS ORAL ORAL ORAL UNK, DAILY, ORAL UNK, UNK, ORAL UNK, UNK, ORAL UNK, UNK, ORAL Date:11/01/99ISR Number: 3387173-7Report Type:Expedited (15-DaCompany Report #94280Age:50 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 5 MG, TID, Other ORAL 10 DAY PT Report Source Product Role Abdominal Pain Upper Anorexia Foreign Health Lioresal Suspension (Baclofen) PS Depression Professional Eye Excision Intraocular Melanoma Lethargy Malignant Melanoma Stage Iv Pain Other Haloperidol Capsule Daktarin Oral Gel Gel Lactulose Syrup Bisacodyl Tablet Prednisolone Tablet Mst 60 Tablet 60 Normax Cyclizine Manufacturer Route ORAL C C C C C C C C Date:11/01/99ISR Number: 3387232-9Report Type:Expedited (15-DaCompany Report #S9432751 Age: Gender:Female I/FU:I Outcome PT Dose Duration Life-Threatening Lung Disorder DAILY, ORAL 25 DAY Vertigo 22-Aug-2005 Page: 64 12:15 PM Report Source Product Role Foreign Lioresal (Baclofen) PS Health Professional Other Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/04/99ISR Number: 3388750-XReport Type:Expedited (15-DaCompany Report #R99-079 Age:47 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Aphasia Aspiration Crying Dyskinesia Euphoric Mood Health Professional Baclofen Tablets 10mg, Watson Laboratories, Inc., Miami PS Watson Laboratories, Inc., ORAL Manufacturer Route APPROX. 40 Intentional Misuse TABS ORAL Memory Impairment Mental Impairment Mood Altered Suicide Attempt Tongue Disorder Vomiting Klonopin Prescription Antihistamines C C Date:11/15/99ISR Number: 3397773-6Report Type:Expedited (15-DaCompany Report #208768 Age:51 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Depression Dyspnoea Lethargy Other Valium (Diazepam) Glyburide (Glyburide) PS Baclofen (Baclofen) Ativan (Lorazepam) Trazodone (Trazodone Hydrochloride) Copaxone (Glatiramer Acetate) Doxazosin Mesilate (Doxazosin Mesylate) Naproxen (Naproxen) Fosinopril (Fosinopril Sodium) SS SS SS ORAL Suicide Attempt Date:11/22/99ISR Number: 3404821-3Report Type:Expedited (15-DaCompany Report #99D--11039 Age:59 YR Gender:Female I/FU:I SS SS C C C ORAL Outcome Dose Duration Hospitalization Initial or Prolonged 25 MG PT Report Source Product Role Pemphigoid Foreign Health Lioresal (Baclofen) PS Antibiotics Sirdalud C C Manufacturer Route ORAL Professional QID Other ORAL Date:11/23/99ISR Number: 3405354-0Report Type:Direct Age:73 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 2TABS BID Hospitalization ORAL Initial or Prolonged 1 TAB TID PT Grand Mal Convulsion Company Report # Report Source Product Role Zanaflex 4mg PS ORAL Lioresal 20mg SS ORAL Diltantin Prozac Kcl C C C ORAL 22-Aug-2005 Page: 65 12:15 PM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/01/99ISR Number: 3411828-9Report Type:Expedited (15-DaCompany Report #R99-073 Age: Gender:Male I/FU:I Outcome Dose Other UNKNOWN PT Report Source Product Role Manufacturer Consumer Baclofen 10 Mg Tablets, Watson Laboratories, Inc. (Miami) PS Watson Laboratories, Inc (Miami) Ibuprofen & Nnaproxen Prazosin Aspirin Nabumetone Gabapentin Atenolol Methocarbamol Hydroxyzine Lansoprazole Tylenol #3 Hydrochlorothiazide Trazodone C C C C C C C C C C C C Route Duration Feeling Cold Hypoaesthesia Muscle Disorder Muscle Twitching Neck Pain 1 TABLET QID Pain UNKNOWN Paraesthesia Peripheral Nerve Injury Radiculopathy Date:12/01/99ISR Number: 3414799-4Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #AR-1295 PT Report Source Product Role Manufacturer Route Abdominal Pain Headache Consumer Baclofen Tablets, 10 Mg (Danbury/Schein) PS Danbury/Schein ORAL Wellbutrin Premarin C C Duration 10 MG TID Rash Papular (ORAL), INCREASED TO 10 MG BID (ORAL) Motrin Ultram C C Date:12/06/99ISR Number: 3414086-4Report Type:Expedited (15-DaCompany Report #99F--11057 Age:48 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 80 MG, DAILY, PT Report Source Product Role Manufacturer Route Dermatitis Bullous Eosinophilia Foreign Health Lioresal Tablet (Baclofen) PS ORAL Linear Iga Disease Professional Rash Macular Rash Pruritic Other Aspegic Powder (Lysine Acetylsalicylate) SS ORAL Xanax Tablet (Alprazolam) SS ORAL Tilcotil Tablet (Tenoxicam) SS ORAL Prozac Capsule (Fluoxetine) SS ORAL Ciflox Tablet (Ciprofloxacin Hydrochloride) SS ORAL ORAL ORAL ORAL ORAL 20 MG, DAILY, ORAL 750 MG, BID, ORAL 22-Aug-2005 Page: 66 10 DAY 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/13/99ISR Number: 3420462-6Report Type:Expedited (15-DaCompany Report #99F--11107 Age:70 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged DAILY, ORAL PT Report Source Product Role Confusional State Delirium Foreign Health Lioresal Tablet (Baclofen) PS Manufacturer Route ORAL Professional Other Date:12/17/99ISR Number: 3425536-1Report Type:Expedited (15-DaCompany Report #99B-10098 Age:53 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Haemoglobin Decreased Pancytopenia Foreign Health Lioresal Unknown (Baclofen) PS White Blood Cell Count Professional Prothiaden Prepulsid C C Manufacturer Route Duration ORAL 55 MG, DAILY, ORAL Decreased Date:12/27/99ISR Number: 3431260-1Report Type:Expedited (15-DaCompany Report #99J--10474 Age:51 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening PT Report Source Product Role Abdominal Pain Lower Amnesia Foreign Health Lioresal Tablet (Baclofen) PS Anxiety Blood Creatinine Increased Blood Urea Increased Chest Discomfort Condition Aggravated Delusion Difficulty In Walking Fall Hallucination Hypoaesthesia Professional Other 45 MG, DAILY Manufacturer Route ORAL Insomnia Persecutory Delusion Suicide Attempt Date:12/28/99ISR Number: 3432094-4Report Type:Expedited (15-DaCompany Report #R99-079 Age:47 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Affect Lability Aspiration Bradyphrenia Crying Dyskinesia Health Professional Baclofen Tablets 10 Mg, Watson Laboratories, Inc., Miami PS Watson Laboratories, Inc., Miami ORAL APPROX. 15 TO Euphoric Mood 20 TABS, ORAL Intentional Misuse Memory Impairment Sedation Suicidal Ideation Suicide Attempt Tongue Disorder Vomiting 22-Aug-2005 Page: 67 12:15 PM Thyroid Celexa Zyprexa Ibuprofen Klonopin C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/28/99ISR Number: 3432734-XReport Type:Expedited (15-DaCompany Report #222988 Age:70 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Confusional State Convulsion Foreign Other Valium Tablets (Diazepam) PS ORAL Baclofen (Baclofen) SS ORAL Dantrolene (Dantrolene) SS ORAL Duration 20 MG DAILY Delirium ORAL Loss Of Consciousness 100 MG DAILY Sedation ORAL 400 MG DAILY ORAL Date:12/29/99ISR Number: 3433661-4Report Type:Direct Age:64 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 40MG PO TID Initial or Prolonged /2 MONTHS PT Company Report # Report Source Confusional State Product Role Baclofen PS Zantac Cardura Atenolol Naproxen C C C C Manufacturer Route ORAL Delirium Difficulty In Walking PRIOR TO Dysarthria EVENT 2 MON Paranoia Date:01/03/00ISR Number: 3435538-7Report Type:Expedited (15-DaCompany Report #99IND10060 Age:17 YR Gender:Male I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Hospitalization Initial or Prolonged 10 MG TID Dermatitis Hypersensitivity Foreign Health Oedema Professional Pruritus Other Lioresal Unknown (Baclofen) PS Promethazine Pacitane C C ORAL ORAL Date:01/05/00ISR Number: 3437781-XReport Type:Expedited (15-DaCompany Report #99D--11189 Age:70 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Coma Condition Aggravated Foreign Health Lioresal Tablet (Baclofen) PS Extrapyramidal Disorder Professional Haemodialysis Overdose Renal Impairment Sedation Other Altra C Manufacturer Route Duration ORAL 5 MG, BID, ORAL Date:01/06/00ISR Number: 3439790-3Report Type:Expedited (15-DaCompany Report #HQ0042430DEC1999 Age:58 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 68 12:15 PM PT Report Source Product Burns Second Degree Dermatitis Exfoliative Erythema Multiforme Pain Rash Erythematous Health Professional Temesta Tablet (Lorazepam) Deroxat (Paroxetine Hydrochloride) Klean-Prep (Macrogol, Potassium Role PS SS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chloride, Sodium Bicarbonate, Sodium Chloride, Sodium Lioresal (Baclofen) Normacol (Frangula Extract, Sterculia) SS SS SS LAVEMENT-PHOS PHATE (29-SEP-99), STERCULIA GOMME Date:01/18/00ISR Number: 3446137-5Report Type:Expedited (15-DaCompany Report #HQ0042430DEC1999 Age:58 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Burns Second Degree Erythema Multiforme Pain Skin Exfoliation Health Professional Temesta Tablet (Lorazepam) Deroxat (Paroxetine Hydrochloride) Klean-Prep (Macrogol, Potassium Chloride, Sodium Bicarbonate, Sodium Chloride, Sodium Lioresal (Baclofen) Normacol (Frangula Extract, Sterulia) Role Manufacturer Route Manufacturer Route PS SS SS SS SS SEE IMAGE Date:01/18/00ISR Number: 3453033-6Report Type:Periodic Age:49 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 40 MG, QID, Company Report #98USA11801 PT Report Source Product Role Confusional State Convulsion Health Professional Baclofen Tablet 20 Mg (Baclofen) PS ORAL Coordination Abnormal ORAL Hallucination Amantadine Tablet Date:01/19/00ISR Number: 3445217-8Report Type:Direct Age:43 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization TITRATED AS Initial or Prolonged ABOVE PO Company Report # PT Report Source Product Role Coma Health Baclofen PS Medication Error Professional Norvasc Nephrocaps Insulin Capoten Calcium Acetate Tenex Aspirin C C C C C C C Renal Failure Chronic Date:01/28/00ISR Number: 3447828-2Report Type:Expedited (15-DaCompany Report #222988 Age:70 YR Gender:Male I/FU:F Outcome Other 22-Aug-2005 Page: 69 PT Confusional State Convulsion Delirium 12:15 PM C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Localised Infection Loss Of Consciousness Respiratory Depression Dose Report Source Product Role Manufacturer Route Foreign Other Valium Tablets (Diazepam) PS ORAL Baclofen (Baclofen) SS ORAL Dantrolene (Dantrolene) SS ORAL Hypnovel (Inj) (Midazolam Hydrochloride) SS Duration Sedation 20 MG DAILY ORAL 100 MG DAILY ORAL 400 MG DAILY ORAL Date:01/31/00ISR Number: 3449090-3Report Type:Expedited (15-DaCompany Report #99D--11039 Age:59 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 25 MG QID PT Report Source Product Role Autoimmune Disorder Blister Foreign Health Lioresal Tablet (Baclofen) PS Dermatitis Bullous Professional Erythema Inflammation Pemphigoid Rash Erythematous Rash Macular Skin Disorder Skin Lesion Urticaria Other ORAL Penicillin Unknown (Penicillin Nos) Mono-Embolex Ampoule Calcium Dispersible Tablet 500 Trusopt Drops Ampho-Moronal Suspension Tavanic Tablet Bifiteral Vigantoletten Antibiotics Musaril SS C C C C C C C C C Manufacturer Route ORAL Sirdalud Fungizid-Ratiopharm C C Date:02/10/00ISR Number: 3456364-9Report Type:Expedited (15-DaCompany Report #00GB-10093 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Bone Marrow Depression Hepatic Function Abnormal Foreign Health Baclofen Unknown (Baclofen) PS ORAL Liver Function Test Professional Abnormal Neutropenia Thrombocytopenia Other Amitriptyline Unknown (Amitriptyline) SS ORAL Amoxycillin Erythromycine Paracetamol C C C Duration 40 MG, QD, ORAL 50 MG, DAILY, ORAL 22-Aug-2005 Page: 70 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/11/00ISR Number: 3456482-5Report Type:Direct Age:67 YR Gender:Male I/FU:I Outcome Dose Duration Required 5MG PO BID Intervention to Prevent Permanent Impairment/Damage PT Company Report # Report Source Sedation Product Role Baclofen PS Manufacturer Route ORAL Date:02/14/00ISR Number: 3457939-3Report Type:Expedited (15-DaCompany Report #00D--10137 Age:82 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 25 MG, TID, PT Report Source Product Role Abdominal Pain Accidental Overdose Foreign Health Lioresal Unknown (Baclofen) PS Confusional State Professional Manufacturer Route Manufacturer Route UNKNOWN Extensor Plantar Response Medication Error Muscle Contractions Involuntary Respiratory Disorder Restlessness Urinary Retention Date:02/22/00ISR Number: 3460039-XReport Type:Direct Age:29 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 175 MCG/24HR Initial or Prolonged IT PT Bradycardia Company Report # Report Source Product Role Baclofen PS Tavist Motrin Phenergan Symmetral Feldene C C C C C Ventricular Extrasystoles Tylenol Extra Strength Date:02/23/00ISR Number: 3462203-2Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other 50.00 MG C Company Report #9938788 PT Report Source Product Role Manufacturer Route Amnesia Consumer Zoloft Tablets PS ORAL Baclofen SS ORAL Zanaflex Urex Vitamin C C C C Duration Health TOTAL:DAILY:O Professional RAL 80.00 MG TOTAL:DAILY:O RAL Date:02/24/00ISR Number: 3462241-XReport Type:Expedited (15-DaCompany Report #222988 Age:70 YR Gender:Male I/FU:F Outcome Other 22-Aug-2005 Page: 71 PT Confusional State Delirium 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Drug Ineffective Epilepsy Infection Report Source Product Role Loss Of Consciousness Respiratory Depression Foreign Other Valium Tablets (Diazepam) PS ORAL Baclofen (Baclofen) SS ORAL Dantrolene (Dantrolene) SS ORAL Hypnovel (Inj) (Midazolam Hydrochloride) SS Manufacturer Route Duration 20 MG DAILY Sedation ORAL 100 MG DAILY ORAL 400 MG DAILY ORAL Date:02/25/00ISR Number: 3463979-0Report Type:Expedited (15-DaCompany Report #00F-10154 Age:34 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 90 MG, DAILY, Initial or Prolonged ORAL PT Report Source Product Blood Bilirubin Increased Foreign Lioresal Hepatitis Cholestatic Health Jaundice Liver Function Test Professional Other Role (Baclofen) Manufacturer Route PS ORAL Dantrium (Dantrolene Sodium) SS ORAL Prozac Solution (Fluoxetine) SS ORAL Fragmine Solution For Injec Valium Tablet Haldol Tablet C C C 150 MG, Abnormal DAILY, ORAL 12 WK 40 MG, DAILY, ORAL Debridat Tablet C Date:02/29/00ISR Number: 3464591-XReport Type:Expedited (15-DaCompany Report #00-0180 Age:27 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Depressed Level Of Consciousness Drug Level Above Health Professional Baclofen Tablets (Strength Unknown) Watson Labs. Miami PS Watson Labs. Miami Unasyn (Strength Unknown), Pfizer Percocet Ditropan SS C C Pfizer Manufacturer Route 120 MG QD Therapeutic Loss Of Consciousness Nephritis Interstitial Renal Failure Date:03/03/00ISR Number: 3469265-7Report Type:Expedited (15-DaCompany Report #A005891 Age:27 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 120.00 MG Required TOTAL:DAILY:O Intervention to RAL Prevent Permanent ORAL Impairment/Damage 22-Aug-2005 Page: 72 12:15 PM PT Report Source Product Role Route Dialysis Drug Level Above Health Professional Unasyn For Injection Baclofen PS SS ORAL Percocet SS ORAL Ditropan C Therapeutic Loss Of Consciousness Nephritis Interstitial FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/23/00ISR Number: 3478991-5Report Type:Expedited (15-DaCompany Report #00-0263 Age:71 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Hallucination Urinary Incontinence Vomiting Health Professional Baclofen Tablets 10 Mg, Watson Laboratories, Inc. Miami PS Watson Laboratories, Inc. Miami ORAL 10 MG, BID, PO Lopressor Zantac Nephro Caps Prinivil Aspirin Nitroglycerin Sublingual Isosorbide Dintirate Date:03/24/00ISR Number: 3538615-5Report Type:Periodic Age:66 YR Gender:Female I/FU:I Outcome Dose C C C C C C C Company Report #USA012831 PT Report Source Product Role Manufacturer Route Weight Increased Consumer Other Meridia PS Knoll Pharmaceutical Co Sub Basf Corp ORAL Manufacturer Route Duration 15 MG OD PO Morphine Baclofen Hydrochlorothiazide Tylox Soma SS SS C C C Date:03/30/00ISR Number: 3482753-2Report Type:Expedited (15-DaCompany Report #A005891 Age:27 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization - PT Report Source Product Role Depressed Level Of Health Unasyn For Injection PS Initial or Prolonged 120.00 MG Required TOTAL:DAILY:O Intervention to RAL Prevent Permanent ORAL Impairment/Damage Consciousness Professional Baclofen SS ORAL Therapeutic Percocet SS ORAL Loss Of Consciousness Nephritis Interstitial Renal Failure Ditropan C Dialysis Drug Level Above Date:04/03/00ISR Number: 3483863-6Report Type:Expedited (15-DaCompany Report #00GB-10239 Age:19 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening PT Report Source Product Role Manufacturer Route Agitation Cyanosis Foreign Health Baclofen Unknown (Baclofen) PS ORAL Hypoxia Professional Respiratory Failure Other Dantrolene Unknown (Dantrolene) SS ORAL Zanaflex Unknown (Tizanidine Hydrochloride) SS ORAL Voltarol C 80 MG QD, ORAL 200 MG, DAILY, ORAL 10 MG DAILY, ORAL 22-Aug-2005 Page: 73 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bisacodyl Lactulose Cefuroxime Temazepam Motilium Ephedrine Frusemide Glycerol Maxolon Morphine Paracetamol Potassium Chloride Senna Cyclizine Date:04/06/00ISR Number: 3484628-1Report Type:Direct Age: Gender: I/FU:I Outcome Dose PT Company Report #USP 52914 Report Source Product Role Manufacturer Lioresal (Baclofen) PS Novartis Manufacturer Route Duration Cardiac Arrest Depressed Level Of Consciousness Grand Mal Convulsion Hypothermia Medication Error Overdose Respiratory Arrest Date:04/06/00ISR Number: 3484728-6Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose C C C C C C C C C C C C C C Company Report # PT Report Source Product Role Condition Aggravated Health Lioresal - Baclofen PS Muscle Spasms Professional Duration 10MG QD Date:04/19/00ISR Number: 3490511-8Report Type:Expedited (15-DaCompany Report #00-0365 Age:42 YR Gender:Male I/FU:I Route Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Anxiety Chest Discomfort Decreased Appetite Disturbance In Attention Consumer Baclofen Tablets 10 Mg, Watson Laboratories, Inc. PS Watson Laboratories, Inc. Celebrex Advil Prilosec Trazadone Ornade C C C C C Route 10 MG, TID Fatigue Insomnia Palpitations Panic Attack Restlessness Tinnitus Date:04/24/00ISR Number: 3491470-4Report Type:Direct Age: Gender: I/FU:I Outcome Dose PT Report Source Product Role Lioresal ... PS C Duration Condition Aggravated Muscle Spasms 22-Aug-2005 Page: 74 Company Report # 12:15 PM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/08/00ISR Number: 3497219-3Report Type:Expedited (15-DaCompany Report #00-0416 Age:55 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Abdominal Distension Abdominal Pain Upper Asthenia Blood Pressure Increased Diarrhoea Dyspnoea Extrasystoles Consumer Baclofen Tablets, 10 Mg, Watson Laboratories, Inc. Miami PS Ultram 100mg, SS Watson Laboratories, Inc., Miami Ortho Pharmaceuticals Klonopin Diazepam Vioxx Albuterol Inhaler Methadone C C C C C Route 6 TABS A DAY Muscle Disorder Nervousness Date:05/09/00ISR Number: 3497748-2Report Type:Expedited (15-DaCompany Report #00-0469 Age:42 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Depression Hallucination Paranoia Psychotic Disorder Sedation Health Professional Other Baclofen Tablets 10 Mg, Watson Laboratories, Inc. Miami PS Watson Laboratories, Inc., Miami Minoxidil Lopressor Zoloft Renagel C C C C 5 MG Speech Disorder INCREASED TO 10 MG (UNKNOWN FREQUENCY) Route Date:05/09/00ISR Number: 3497770-6Report Type:Expedited (15-DaCompany Report #00-0180 Age:27 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Abdominal Pain Agitation Coma Convulsion Depressed Level Of Health Professional Baclofen Tablets (Strength Unknown) Watson Laboratories Inc PS Watson Laboratories Inc Unasyn (Strength Unknown), Pfizer SS Pfizer 120 MG QD Consciousness Drug Toxicity Loss Of Consciousness Nephritis Interstitial Renal Failure Renal Impairment Date:05/09/00ISR Number: 3497773-1Report Type:Expedited (15-DaCompany Report #00-0365 Age:42 YR Gender:Male I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 75 12:15 PM PT Anxiety Chest Discomfort Decreased Appetite Disturbance In Attention Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fatigue Insomnia Palpitations Dose Report Source Product Role Manufacturer Consumer Baclofen Tablets 10 Mg, Watson Laboratories, Inc. Miami Div. PS Watson Laboratories, Inc. Miami Div. Celebrex Advil Prilosec Trazadone Ornade C C C C C Route Duration Panic Attack Restlessness Tinnitus 10 MG, TID Date:05/16/00ISR Number: 3500940-1Report Type:Direct Age:73 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 10MG TID Initial or Prolonged PT Company Report # Report Source Product Role Dizziness Baclofen PS Dyspnoea Lipitor Reglain Lanoxin Pepecid Cardizem Flovet Coumadin Prednisone Combivant C C C C C C C C C Date:05/22/00ISR Number: 3503501-3Report Type:Direct Age:46 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 110 MG QID > Hospitalization TO 120 MG QID Initial or Prolonged Manufacturer Route Manufacturer Route Company Report # PT Report Source Product Role Angina Pectoris Health Baclofen/Lioreseal PS Myocardial Infarction Professional ... C Required Intervention to Prevent Permanent Impairment/Damage Date:05/31/00ISR Number: 3506698-4Report Type:Direct Age:67 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 76 12:15 PM PT Hepatitis Company Report # Report Source Product Role Baclofen 20mg Tab Azathioprine 50 Mg Tab Interferon Beta 1b Vi Inj Syringe 2.5-3ml/Ndl Tuberculin Syringe PS SS C C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/00ISR Number: 3507665-7Report Type:Expedited (15-DaCompany Report #99F--10645 Age:65 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 5 MG, DAILY, PT Report Source Product Role Manufacturer Route Aggression Agitation Foreign Literature Lioresal PS Novartis Pharmaceuticals Corp ORAL Blood Bicarbonate Health Increased Blood Creatinine Increased Blood Urea Increased Confusional State Diabetes Mellitus Electroencephalogram Abnormal Encephalopathy Haemoglobin Decreased Hyperglycaemia Infarction Muscle Rigidity Nervous System Disorder Professional Other Route ORAL Rifampicin Rimifon Pirilene Mopral Fozitec Hemodialysis C C C C C C Date:06/06/00ISR Number: 3508574-XReport Type:Expedited (15-DaCompany Report #00-0469 Age:42 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 5 MG TID; 10 PT Report Source Product Role Manufacturer Cognitive Disorder Delusional Disorder, Health Professional Baclofen PS Watson Laboratories Inc Persecutory Type Other Minoxidil Lopressor Zoloft Renagel C C C C MG TID Depression Hallucination Post-Traumatic Stress Disorder Psychotic Disorder Sedation Speech Disorder Date:06/06/00ISR Number: 3508575-1Report Type:Expedited (15-DaCompany Report #00-0416 Age:55 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Abdominal Distension Abdominal Pain Upper Asthenia Consumer Baclofen PS Watson Laboratories Inc Ultram SS Klonopin Diazepam Vioxx Albuterol Methadone C C C C C 6 TABS A DAY Blood Pressure Increased Diarrhoea Drug Dependence Drug Withdrawal Syndrome Dyspnoea Extrasystoles Fatigue Muscle Disorder Nervousness 22-Aug-2005 Page: 77 12:15 PM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/23/00ISR Number: 3518929-5Report Type:Expedited (15-DaCompany Report #00-749 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 20 MG QID PO PT Report Source Product Role Manufacturer Route Coma Disorientation Other Baclofen PS Watson Laboratories Inc ORAL ORAL Hyperhidrosis Speech Disorder Ultram 50 Mg Tablets, Ortho-Mcneil SS Ortho-Mcneil Urecholine 25 Mg Merck SS Merck Dilantin Gabatril Ogen Pepcid Symmetrel C C C C C QD PO 25 MG TID Date:06/26/00ISR Number: 3519908-4Report Type:Expedited (15-DaCompany Report #00D-10813 Age:82 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 45 MG, TID, PT Report Source Product Role Manufacturer Blister Haemorrhage Foreign Health Lioresal PS Novartis Pharmaceuticals Corp Professional Other Furosemid C Route Date:06/26/00ISR Number: 3520800-XReport Type:Expedited (15-DaCompany Report #WAES 00061841 Age:66 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1 GM DAILY 62 MON PT Report Source Product Role Manufacturer Route Dyspnoea Pneumonitis Foreign Health Professional Other Zocor PS Merck Research Laboratories Div Merck Co Inc ORAL Tegretol (Carbamazepine) SS ORAL Lioresal (Baclofen) SS ORAL 5MG Date:06/27/00ISR Number: 3520695-4Report Type:Expedited (15-DaCompany Report #1382058A Age:52 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Route Completed Suicide Literature Health Professional Tylenol PS Mcneil Consumer Products Co Div Mcneilab Inc ORAL Duration PO Baclofen SS Methocarbamol C PO Date:07/10/00ISR Number: 3580989-3Report Type:Periodic Age:40 YR Gender:Female I/FU:I Outcome 22-Aug-2005 Page: 78 PT Chest Pain Decreased Appetite Dry Mouth Haemorrhoids Headache Increased Appetite Insomnia 12:15 PM Company Report #USA013334 ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Nausea Pain In Extremity Dose Report Source Product Role Manufacturer Route Consumer Other Meridia PS Knoll Pharmaceutical Co Sub Basf Corp Generic Robitussin D Pro-Image Allegra Sudafed Benadryl Cardizem Aspirin SS SS SS SS SS SS SS ORAL Motrin Aleve Vioxx Naproxen SS SS SS SS ORAL Darvocet-N Vicodin Baclofen SS SS SS ORAL Phernilin-Forte (50/650 Mg) SS ORAL Duration TAB UNK PO TAB UNK PO TAB UNK PO TAB UNK PO Date:07/12/00ISR Number: 3528336-7Report Type:Expedited (15-DaCompany Report #00F--10582 Age:66 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 5MG, DAILY, PT Report Source Product Role Manufacturer Route Dyspnoea Pneumonia Foreign Health Lioresal PS Novartis Pharmaceuticals Corp ORAL Professional ORAL Other Tegretol Tablet (Carbamazepine) SS ORAL Lodales Tablet (Simvastatin) SS ORAL UNK, DAILY, ORAL ORAL 2 MON Date:07/20/00ISR Number: 3532343-8Report Type:Direct Age:55 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 30MG GT QD Initial or Prolonged 10MG TID 22-Aug-2005 Page: 79 12:15 PM PT Company Report # Report Source Product Role Neutropenia Prevacid PS Pyrexia Baclofen SS Insulin Aspirin Vitamin C Ativan Oscal With Vit D Pericolace Cipro Eye Drops Erythromycin Lopressor Nitro Patch Robittusin Dm C C C C C C C C C C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/26/00ISR Number: 3535742-3Report Type:Expedited (15-DaCompany Report #00D-10813 Age:82 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1 DF, DAILY, PT Report Source Product Role Manufacturer Blister Dermatitis Bullous Foreign Health Lioresal PS Novartis Pharmaceuticals Corp Drug Eruption Professional Haemorrhage Other Furosemid ... ... ... C C C C Route PERCUTANEOUS Date:08/03/00ISR Number: 3543697-0Report Type:Periodic Age:48 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Nausea Initial or Prolonged Respiratory Depression INTRATHECAL 525MEG/DAY Company Report #99-08-0254 Report Source Product Role Manufacturer Consumer Baclofen PS Zenith Goldline Pharmaceuticals Prozac Prempro C C Route INTRATHECAL Date:08/03/00ISR Number: 3543699-4Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #00-04-0188 PT Report Source Product Role Manufacturer Route Oedema Peripheral Consumer Baclofen PS Zenith Goldline Pharmaceuticals ORAL Duration 20 MG ORAL Diuretics Date:08/03/00ISR Number: 3543703-3Report Type:Periodic Age:75 YR Gender:Male I/FU:I Company Report #00-05-0222 C Outcome Dose Other PT Report Source Product Role Manufacturer Route Vision Blurred Consumer Baclofen PS Zenith Goldline Pharmaceuticals ORAL Manufacturer Route Duration 5MG TID ORAL Hytrin Verapamil Date:08/04/00ISR Number: 3541259-2Report Type:Direct Age:17 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization INTRATHECAL VARIES Initial or Prolonged PUMP PT C C Company Report # Report Source Blood Creatinine VIA Increased Product Role Baclofen PS Bisacodyl Lasix Aldactone C C C Blood Urea Increased INTRATHECAL Dehydration Oedema Date:08/08/00ISR Number: 3588659-2Report Type:Periodic Age:46 YR Gender:Female I/FU:I Outcome Dose Company Report #USA013973 PT Report Source Product Role Manufacturer Route Constipation Consumer Other Vicoprofen PS Knoll Pharmaceutical Co Sub Basf Corp ORAL Duration 1 TAB TID PO Baclofen TAB PO 22-Aug-2005 Page: 80 12:15 PM SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Neurontin Zocor Avapro Multivitamins C C C C Date:08/09/00ISR Number: 3546777-9Report Type:Expedited (15-DaCompany Report #033-0945-M0000066 Age:67 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening PT Report Source Product Role Manufacturer Route Coma Dyspnoea Foreign Health Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Laryngeal Disorder Professional 200 MG DAILY PER ORAL Lung Disorder Respiratory Depression Laroxyl (Amitriptyline Hydrochloride) SS ORAL Lioresal (Baclofen) SS ORAL Lexomil (Bromazepam) SS ORAL Levothyrox (Levothyroxine Sodium) Diffu-K (Potassium Chloride) C 25 MG DAILY PER ORAL 15 MG DAILY PER ORAL 9 MG DAILY PER ORAL C Date:08/10/00ISR Number: 3548292-5Report Type:Expedited (15-DaCompany Report #00GB-10309 Age:44 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 7.5 MG DAILY PT Report Source Product Role Manufacturer Route Delusional Disorder, Persecutory Type Foreign Health Lioresal PS Novartis Pharmaceuticals Corp ORAL Professional ORAL Other Diazepam Diclofenac Zopiclone Fluoxetine C C C C Date:08/10/00ISR Number: 3548299-8Report Type:Expedited (15-DaCompany Report #00F--10677 Age:67 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 15 MG DAILY Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Coma Depressed Level Of Foreign Health Lioresal PS Novartis Pharmaceuticals Corp ORAL Consciousness Professional Drug Interaction Dyspnoea Other Lexomil Tablet (Bromazepam) SS ORAL Laroxyl Tablet (Amitriptyline Hydrochloride) SS ORAL Neurontin Capsule (Gabapentin) SS ORAL Diffu-K Capsule Levothyrox Tablet C C 9 MG DAILY Laryngeal Disorder ORAL Lung Disorder Overdose Respiratory Depression 25 MG Respiratory Disorder DAILYORAL 200 MG DAILY ORAL 22-Aug-2005 Page: 81 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/13/00ISR Number: 3570383-3Report Type:Direct Age:55 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 1 PO QD PT Company Report # Report Source Product Role Manufacturer Route Agitation Metabolite PS ORAL Circulatory Collapse Baclofen SS ORAL Coma Convulsion Drug Abuser St John'S Wort Melatonin SS SS 1 PO QD Date:09/15/00ISR Number: 3572537-9Report Type:Expedited (15-DaCompany Report #HQ0900212SEP2000 Age:52 YR Gender:Female I/FU:I Outcome Dose Duration Death ORAL Life-Threatening ORAL Hospitalization ORAL Initial or Prolonged PT Report Source Product Role Manufacturer Route Activated Partial Health Robaxin PS Ah Robins Co ORAL Thromboplastin Time Professional Acetaminophen SS ORAL Baclofen SS ORAL Prolonged Blood Bicarbonate Decreased Blood Pressure Fluctuation Coma Hypothermia Loss Of Consciousness Pco2 Decreased Po2 Increased Pupillary Reflex Impaired Suicide Attempt Date:09/22/00ISR Number: 3578905-3Report Type:Expedited (15-DaCompany Report #PHBS2000CA08880 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization - PT Report Source Product Role Manufacturer Cerebrovascular Accident Foreign Lioresal PS Novartis Route Initial or Prolonged 5 MG, TID, Confusional State Health Disorientation Professional Pharmaceuticals Corp ORAL ORAL Other Date:09/25/00ISR Number: 3579462-8Report Type:Expedited (15-DaCompany Report #PHEH2000US08592 Age:37 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Abdominal Pain Alanine Aminotransferase Consumer Lioresal PS Novartis Pharmaceuticals Corp ORAL Duration 30 MG, QID, Increased ORAL Aspartate Aminotransferase Increased Blood Alkaline Phosphatase Increased Liver Function Test Abnormal 22-Aug-2005 Page: 82 12:15 PM Valproic Acid Phenobarbital C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/28/00ISR Number: 3582584-9Report Type:Direct Age:73 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Company Report # Report Source Mental Impairment Product Role Baclofen PS Manufacturer Route Route Date:10/04/00ISR Number: 3587645-6Report Type:Expedited (15-DaCompany Report #A032407 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 30.00 MG Initial or Prolonged TOTAL: TID Disability Required QID Intervention to 75.00 MG Prevent Permanent TOTAL: TID Impairment/Damage 80.00 MG PT Report Source Product Role Manufacturer Aphasia Consumer Procardia PS Pfizer Inc Brain Contusion Drug Interaction Guaifenesin/Phenylpr opanolamine SS Dysphagia Dantrium SS Baclofen SS Zanaflex Claritin Cranberry Juice C C C Aspiration Parenteral Nutrition Pneumonia Road Traffic Accident TOTAL: QID Skin Ulcer T-Cell Lymphoma Date:10/06/00ISR Number: 3590703-3Report Type:Expedited (15-DaCompany Report #PHEH2000US08924 Age: Gender:Female I/FU:I Outcome Dose Other 100 MG, ORAL PT Report Source Product Role Manufacturer Route Coma Overdose Health Professional Lioresal PS Novartis Pharmaceuticals Corp ORAL Duration 1 DAY Psychotic Disorder Date:10/13/00ISR Number: 3594850-1Report Type:Expedited (15-DaCompany Report #PHEH2000US09173 Age:84 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 20 MG QID PT Report Source Product Role Manufacturer Route Hallucination Psychotic Disorder Health Professional Lioresal PS Novartis Pharmaceuticals Corp ORAL Route ORAL Date:10/18/00ISR Number: 3597570-2Report Type:Expedited (15-DaCompany Report #A032407 Age: Gender:Male I/FU:F Outcome Dose Duration Hospitalization 30.00 MG Initial or Prolonged TOTAL: TID Disability Required QID Intervention to 75.00 MG Prevent Permanent TOTAL: TID Impairment/Damage 80.00 MG PT Report Source Product Role Manufacturer Accident Consumer Procardia PS Pfizer Inc Aspiration Health Brain Contusion Dysphagia Professional Guaifenesin/Phenylpr opanolamine SS Dantrium SS Baclofen SS Zanaflex Claritin Cranberry Juice C C C Mutism Pneumonia Refusal Of Treatment By Relative TOTAL: QID T-Cell Lymphoma Ulcer Vomiting 22-Aug-2005 Page: 83 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/20/00ISR Number: 3598920-3Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Required 1PO BID Intervention to Prevent Permanent Impairment/Damage PT Company Report # Report Source Product Role Confusional State Baclofen PS Euphoric Mood Hypotension Lethargy Memory Impairment Psychomotor Hyperactivity Apap 650 Mg Asaec 81 Mg Levothyroxine 0.1 Mg Hct/Triamterene Tc#3 1-2 Tab Baclofen C C C C C C Manufacturer Route ORAL Date:10/23/00ISR Number: 3600637-3Report Type:Expedited (15-DaCompany Report #PHFR2000GB01595 Age:2 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening PT Report Source Product Role Manufacturer Route Aphasia Coma Foreign Health Lioresal PS Novartis Pharmaceuticals Corp ORAL Convulsion Professional Diarrhoea Other Route 2.5 ML, BID, ORAL (SEE IMAGE) 17 DAY Face Oedema Sedation Date:10/24/00ISR Number: 3600288-0Report Type:Expedited (15-DaCompany Report #00-1458 Age:60 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Arrhythmia Depressed Level Of Consciousness Drug Interaction Hypotension Loss Of Consciousness Sinus Bradycardia Syncope Health Professional Other Baclofen PS Watson Laboratories Inc Date:10/24/00ISR Number: 3600465-9Report Type:Direct Age:33 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Required INTRATHECAL 100MG Intervention to INTRATHECAL; Prevent Permanent 50MG Impairment/Damage INTRATHECAL PT Confusional State Convulsion Headache 22-Aug-2005 Page: 84 12:15 PM Report Source Product Role Manufacturer Lioresal Intrathecal-Medtroni c PS Medtronic Oxycodone C Mental Impairment Date:10/25/00ISR Number: 3601207-3Report Type:Direct Age:84 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization Initial or Prolonged Disability Company Report # PT Acute Psychosis Bradycardia Cardiac Arrest Condition Aggravated Confusional State Delirium Company Report # Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Depressed Level Of Consciousness Dissociation Dose Report Source Product Role Baclofen PS Manufacturer Route Duration Hallucination 20 MG QD Mania RECEIVED X3 Medication Error DOSES Speech Disorder Date:10/31/00ISR Number: 3605245-6Report Type:Expedited (15-DaCompany Report #PHRM2000FR01545 Age:40 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening PT Report Source Product Role Manufacturer Route Atrial Fibrillation Foreign Health Lioresal PS Novartis Pharmaceuticals Corp ORAL ORAL Professional Date:11/02/00ISR Number: 3605925-2Report Type:Expedited (15-DaCompany Report #PHEH2000US09173 Age:84 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 20 MG, QID, Disability ORAL PT Report Source Product Role Manufacturer Route Acute Psychosis Arthralgia Health Professional Lioresal PS Novartis Pharmaceuticals Corp ORAL Cardiac Arrest Confusional State Delirium Depressed Level Of Consciousness Dissociation Hallucination Ischaemic Stroke Mania Medication Error Pain In Extremity Pressure Of Speech Psychotic Disorder Single Photon Emission Computerised Tomogram Abnormal Speech Disorder Date:11/21/00ISR Number: 3614710-7Report Type:Expedited (15-DaCompany Report #00-1458 FOL #1 Age:60 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 85 12:15 PM PT Report Source Product Role Manufacturer Arrhythmia Blood Pressure Increased Depressed Level Of Consciousness Disorientation Dizziness Drug Interaction Heart Rate Decreased Hypotension Loss Of Consciousness Petit Mal Epilepsy Sinus Bradycardia Speech Disorder Syncope Health Professional Other Baclofen PS Watson Laboratories Inc Neurontin Celebrex Plavis Zoloft Sinequan Methadone Aspirin C C C C C C C Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/21/00ISR Number: 3615604-3Report Type:Expedited (15-DaCompany Report #001-0945-M0001206 Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG (600 PT Report Source Product Role Manufacturer Route Abdominal Pain Upper Blood Electrolytes Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Decreased MG TID ) PER Disorientation ORAL Drug Interaction (Methadone) SS ORAL Drug Level Above Morphine SS ORAL Therapeutic Baclofen SS ORAL Hypertension Memory Impairment Migraine Muscle Contractions Involuntary Tachycardia Tremor Zoloft (Sertraline Hydrochloride) Clonidine Cardizem (Diltiazem Hydrochloride) (Potassium) Theophylline Hydrochlorothiazide Flovent (Fluticasone Propionate) (Fluocinonide) Combivent (Ipratropium Bromide, Salbutamol Sulfate) Teargen (Benzalkonium Chloride) Vitamin B12 (Cyancobalamin) Vasocon (Phenylmercuric Acetate, Sodium Carbonate Anhydrous, Naphazoline Docusate Compazine (Prochlorperazine Edisylate) PER ORAL PER ORAL PER ORAL C C C C C C C C C C C C C C (Capsaicin) Herbal Natural Estrogen Vitamin E (Tocopherol) Coenzyme Q10 (Ubidecarenone) Stresstab(Vitamins Nos) (Garlic) Very Green Supplement Echinacea Extract Vicodin (Paracetamol, Hydrocodone Bitartrate) Bacitracin /Polymixin Ointment) Benadryl (Diphenhydramine Hydrochloride) 22-Aug-2005 Page: 86 12:15 PM C C C C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ibuprofen Nystatin Cream C C Date:11/21/00ISR Number: 3615652-3Report Type:Expedited (15-DaCompany Report #PHEH2000US08924 Age:84 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 20 MG, QID, Disability ORAL Other PT Report Source Product Role Manufacturer Route Acute Psychosis Agitation Health Professional Lioresal PS Novartis Pharmaceuticals Corp ORAL Cardiac Arrest Cerebral Ischaemia Coma Computerised Tomogram Abnormal Confusional State Delirium Disorientation Hallucination Overdose Psychotic Disorder Single Photon Emission Computerised Tomogram Abnormal Speech Disorder Thinking Abnormal Hydroxyurea (Hydroxycarbamide) Synthroid Nifedipine Flovent (Fluticasone Propionate) C C C C Date:11/21/00ISR Number: 3616938-9Report Type:Expedited (15-DaCompany Report #001-0945-M001206 Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1800 MG (600 PT Report Source Product Role Manufacturer Route Abdominal Pain Upper Blood Electrolytes Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Decreased MG, TID) PER Disorientation ORAL Drug Level Above PER ORAL Methadone SS ORAL Therapeutic Morphine SS ORAL Dysgraphia Baclofen SS ORAL Hypertension Migraine Movement Disorder Pain Tachycardia Tremor Zoloft Clonidine Cardizem Potassium Theophylline Hydrochlorothiazide Flovent Fluocinonide Combivent Teargen Vitamin B12 Vasocon Docusate Compazine Capsaicin Herbal Natural Estrogen Vitamin E Coenzyme Q10 Stresstab Garlic Very Green C C C C C C C C C C C C C C C PER ORAL PER ORAL 22-Aug-2005 Page: 87 12:15 PM C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Supplement Echinacea Extract Vicodin Bacitracin/Polymixin Ointment Benadryl Ibuprofen Nystatin Cream C C C C C C C Date:11/22/00ISR Number: 3617857-4Report Type:Expedited (15-DaCompany Report #PHEH2000US09173 Age:84 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 20 MG, QID, Disability ORAL PT Report Source Product Role Manufacturer Route Bradycardia Brain Stem Ischaemia Health Professional Lioresal PS Novartis Pharmaceuticals Corp ORAL Manufacturer Route Cardiac Arrest Cerebrovascular Disorder Confusional State Delirium Depressed Level Of Consciousness Dissociation Hallucination Logorrhoea Mania Medication Error Pain In Extremity Psychotic Disorder Sick Sinus Syndrome Single Photon Emission Computerised Tomogram Abnormal Speech Disorder Thinking Abnormal Hydroxyurea Synthroid Flovent Nifedipine-Slow Release C C C C Date:11/28/00ISR Number: 3618194-4Report Type:Expedited (15-DaCompany Report #HQ0900212SEP2000 Age:52 YR Gender:Female I/FU:F Outcome Dose PT Duration Report Source Product Role Death ORAL Life-Threatening Hospitalization ORAL Initial or Prolonged ORAL Activated Partial Robaxin PS Thromboplastin Time Prolonged Acetaminophen (Paracetamol) SS ORAL Blood Bicarbonate Baclofen (Baclofen,) SS ORAL Decreased Blood Pressure Fluctuation Completed Suicide Electroencephalogram Abnormal Haemorrhage Hypothermia Loss Of Consciousness Pco2 Decreased Po2 Decreased 22-Aug-2005 Page: 88 12:15 PM Literature Ah Robins Co ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/29/00ISR Number: 3618933-2Report Type:Expedited (15-DaCompany Report #PHFR2000GB01907 Age:5 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 700 UG/DAILY PT Report Source Product Role Manufacturer Renal Failure Foreign Health Lioresal PS Novartis Pharmaceuticals Corp Route Professional Other Date:12/06/00ISR Number: 3622690-3Report Type:Expedited (15-DaCompany Report #00-1678 Age:77 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Anorexia Condition Aggravated Other Baclofen PS Watson Laboratories Inc ORAL Duration 5 MG, BID, Dysphagia PO; 2.5 MG, Failure To Thrive BID, PO Sedation Speech Disorder Lopressor Zantac C C Date:12/11/00ISR Number: 3626940-9Report Type:Expedited (15-DaCompany Report #PHRM2000FR01800 Age:80 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening PT Report Source Product Role Manufacturer Route Confusional State Memory Impairment Foreign Health Lioresal PS Novartis Pharmaceuticals Corp ORAL 30 MG/DAY, Professional ORAL Other Comtan Tablet Modopar (Levodopa, Benserazide Hydrochloride) Capsule Requip (Ropinirole Hydrochloride) C C Tablet C Date:12/12/00ISR Number: 3627611-5Report Type:Expedited (15-DaCompany Report #2000-12-0048 Age:24 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Convulsion Initial or Prolonged INTRAVENOUS 5 MG QD Report Source Product Role Manufacturer Foreign Health Polaramine PS Schering Corp Sub Schering Plough Corp Cortancyl Injectable SS Lioresal Tablets SS ORAL Skenan Capsules SS ORAL Route Professional INTRAVENOUS Other INTRAVENOUS 50 MG QD INTRAVENOUS 2 QD ORAL 30 MG QD ORAL Date:12/18/00ISR Number: 3633508-7Report Type:Expedited (15-DaCompany Report #PHRM2000FR01837 Age:80 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 5 MG, BID, PT Report Source Product Role Manufacturer Route Drug Interaction International Normalised Foreign Health Lioresal PS Novartis Pharmaceuticals Corp ORAL Ratio Increased Professional ORAL Other UNK, UNK, ORAL 22-Aug-2005 Page: 89 4 DAY 12:15 PM Coumadine (Warfarin Sodium) Tablet SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gardenal "Specia" (Phenobarbital) Tablet SS ORAL UNK, UNK, ORAL 4 DAY Date:01/03/01ISR Number: 3641648-1Report Type:Expedited (15-DaCompany Report #001-0945-M0000196 Age:40 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG(300 MG Other TID):2400MG(8 PT Report Source Product Role Manufacturer Route Arthralgia Asthenia Consumer Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Blood Potassium Decreased Carpal Tunnel Syndrome 00MG Cholelithiasis TID):2100MG(7 Cholestasis 00MG Decreased Activity Baclofen SS ORAL Depression Ms Contin SS Difficulty In Walking Dry Mouth Propulsid Methadone SS SS Fall Percocet SS Gallbladder Disorder Valium SS Gallbladder Pain Zanaflex SS ORAL Headache Zoloft SS ORAL 80 MG PER Dental Caries ORAL 1600 MG 2500 MG 1 OR 2 (Q 4 H Fatigue PRN) 80 MG 8 MG PER ORAL 200 MG PER Hypoaesthesia ORAL Hypothyroidism Hydrochlorothiazide SS ORAL Veetids SS ORAL Abnormal Lymphadenopathy Malnutrition Synthroid Oxy Ir (Oxycodone Hydrochloride) SS Movement Disorder Lasix SS Nervous System Disorder Ritalin SS Oedema Peripheral K-Dur SS Osteoporosis Ovarian Cyst Pain In Extremity Pruritus Skin Discolouration Skin Ulcer Seroquel Ketamine Klonopin Corgard Relafen Celebrex SS SS SS SS SS SS Tendon Disorder Carafate SS Vomiting Dextromethorphan SS Weight Decreased Weight Increased Nadolol Tegaderm SS SS 100 MG PER Joint Dislocation ORAL Lethargy 2000 MG PER Liver Function Test ORAL 1 WK SS 8-10 DAILY 80 MG 80 MG 20 MCG 800 MG 4 MG 200 MG Date:01/08/01ISR Number: 3648961-2Report Type:Expedited (15-DaCompany Report #00-1678 FOL# 1 Age:77 YR Gender:Female I/FU:F Outcome Dose Death Other PT Report Source Product Role Manufacturer Route Anorexia Condition Aggravated Decreased Appetite Other Baclofen Tablets 10 Mg, PS Watson Laboratories Inc ORAL Duration 2.5 MG BID PO Dysphagia Eating Disorder Baclofen Tablets 10 Mg SS Failure To Thrive Sedation Speech Disorder Lopressor Zantac C C 5 MG BID PO 22-Aug-2005 Page: 90 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/22/01ISR Number: 3652975-6Report Type:Expedited (15-DaCompany Report #PHBS2001US00534 Age:27 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Coma Convulsion Literature Health Lioresal PS Novartis Pharmaceuticals Corp Drug Interaction Drug Toxicity Electroencephalogram Abnormal Haemodialysis Lethargy Professional Unasyn(Sultamicillin ) SS Route Duration 120 MGDAY Date:01/23/01ISR Number: 3652741-1Report Type:Expedited (15-DaCompany Report #00-1458 FOL #2 Age:60 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Blood Pressure Increased Depressed Level Of Consciousness Dizziness Drug Interaction Hypotension Loss Of Consciousness Sinus Bradycardia Speech Disorder Syncope Health Professional Other Baclofen PS Watson Laboratories Inc See B5 See B5 SS C Route Date:02/02/01ISR Number: 3658416-7Report Type:Expedited (15-DaCompany Report #01-0081 Age: Gender: I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Overdose Health Professional Company Representative Baclofen PS Klonopin Tablets SS Watson Laboratories Inc Hoffmann-Laroche Route Date:02/05/01ISR Number: 3660536-8Report Type:Periodic Age:72 YR Gender:Female I/FU:I Outcome Dose Other 10 MG TOTAL Company Report #A009870 PT Report Source Product Role Manufacturer Route Headache Consumer Zyrtec PS Pfizer Inc ORAL Baclofen SS ORAL Flonase SS NASAL Duration Pruritus DAILY ORAL 20 MG TOTAL BID ORAL BID NASAL Date:02/08/01ISR Number: 3662369-5Report Type:Direct Age:76 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 91 12:15 PM PT Mental Impairment Vomiting Company Report # Report Source Product Role Baclofen PS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/08/01ISR Number: 3662373-7Report Type:Direct Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Confusional State Hallucination Date:02/15/01ISR Number: 3666007-7Report Type:Direct Age:80 YR Gender: I/FU:I Outcome Dose Duration Hospitalization 10MG TID Initial or Prolonged Company Report # PT Product Role Baclofen PS Manufacturer Route Manufacturer Route Company Report # Report Source Product Role Confusional State Baclofen PS Disorientation Naproxen Fluoxetine Levothyroxine Lisinopril Terazosin C C C C C Date:02/28/01ISR Number: 3671474-9Report Type:Expedited (15-DaCompany Report #001-0945-M0000462 Age:72 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 900 MG (300 PT Report Source Product Role Manufacturer Route Aphonia Blood Glucose Increased Health Professional Neurontin PS Parke Davis Pharmaceuticals Ltd ORAL Cellulitis MG, TID), PER Disturbance In Attention ORAL Dizziness Baclofen (Baclofen) SS (Insulin) Aleve (Naproxen Sodium) C 75 MG (25 MG, Headache TID), PER Nausea ORAL Tremor Vision Blurred C ORAL Date:02/28/01ISR Number: 3672718-XReport Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Company Report #A037642 PT Report Source Product Role Manufacturer Intentional Misuse Suicide Attempt Other Zoloft PS Pfizer Pharmaceuticals Inc Glyburide Penicillin Baclofen Ibuprofen Fluoxetine SS SS SS C C Route Date:03/01/01ISR Number: 3672327-2Report Type:Expedited (15-DaCompany Report #PHBS2001BE02018 Age:68 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Body Temperature Increased Foreign Health Lioresal PS Novartis Pharmaceuticals Corp ORAL Duration 5 MG, TID, Professional ORAL Other 22-Aug-2005 Page: 92 12:15 PM Loramet (Lormetazepam) D-Cure Dafalgan Codeine (Paracetamol) Folc Acid C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/01/01ISR Number: 3683080-0Report Type:Periodic Age:72 YR Gender:Female I/FU:I Outcome Dose Other Company Report #2000AU04364 PT Report Source Product Role Manufacturer Dry Mouth Dry Skin Dry Throat Glossodynia Nasal Dryness Other Plendil PS Astrazeneca Pharmaceuticals Lp Cozaar Oxybutynin "Generics Uk" SS Baclofen Insulin Nitro Patch C C C Route Duration SS ORAL 5 MG TID PO Pruritus Date:03/06/01ISR Number: 3674694-2Report Type:Direct Age:46 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Nausea Initial or Prolonged Vomiting INTRAVENOUS 2000MCG/ML-20 Weight Decreased ML IV Company Report # Report Source Product Role Baclofen Intrathecal Pump PS Verapamil Premarin Omeprazole Cisapride Diazepam Trazadone C C C C C C Manufacturer Route Date:03/06/01ISR Number: 3674755-8Report Type:Expedited (15-DaCompany Report #PHEH2001US01929 Age:2 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL Required Intervention to Prevent Permanent PT Report Source Product Role Manufacturer Route Accidental Overdose Coma Health Professional Lioresal PS Novartis Pharmaceuticals Corp ORAL Convulsion Respiratory Depression Impairment/Damage Date:03/13/01ISR Number: 3681032-8Report Type:Expedited (15-DaCompany Report #PHBS2001BE02018 Age:68 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Body Temperature Increased Foreign Health Lioresal PS Novartis Pharmaceuticals Corp ORAL Professional Other Loramet (Lorametazepam) D-Cure Folic Acid Dafalgan Codeine (Paracetamol) Duration 5 MG TID ORAL Date:03/16/01ISR Number: 3683086-1Report Type:Expedited (15-DaCompany Report #HQ5452112N0V1999 Age:51 YR Gender:Male I/FU:F Outcome Death 22-Aug-2005 Page: 93 PT Bronchitis Acute Cardiac Failure Congestive 12:15 PM C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Collapse Of Lung Drug Interaction Drug Level Above Report Source Product Role Manufacturer Route Therapeutic Consumer Reglan PS Ah Robins Co ORAL Baclofen Dantrium (Dantrolene Sodium) SS Duration ORAL Dyspnoea Respiratory Depression Respiratory Failure SS ORAL Darvocet-N (Dextropropoxyphene/ Paracetamol) SS ORAL Imipramine SS FOUR TIMES Sedation DAILY, ORAL ORAL Date:03/19/01ISR Number: 3684033-9Report Type:Direct Age: Gender: I/FU:I Outcome Dose PT Company Report # Report Source Product Role Manufacturer Baclofen Tegretol Estradiol PS SS SS Novartis Route Duration Medication Error Date:03/19/01ISR Number: 3684297-1Report Type:Expedited (15-DaCompany Report #PHEH2001US02375 Age:50 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Electrocardiogram Q Waves Health Professional Lioresal PS Novartis Pharmaceuticals Corp ORAL Duration 10 MG, QD ORAL Date:03/19/01ISR Number: 3684313-7Report Type:Expedited (15-DaCompany Report #2000COU1502 Age:34 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Route Completed Suicide Literature Health Coumadin PS Dupont Merck Pharmaceutical Co ORAL Professional Ni (Amitriptyline) SS ORAL Ni (Baclofen) SS ORAL Duration PO PO PO Date:03/26/01ISR Number: 3690183-3Report Type:Expedited (15-DaCompany Report #PHBS2001BE02884 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Ageusia Anosmia Foreign Health Lioresal PS Novartis Pharmaceuticals Corp ORAL Duration 5 MG, TID, Professional ORAL 2 DAY Other Date:03/30/01ISR Number: 3699553-0Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #A013553 PT Report Source Product Role Manufacturer Route Hypertonia Consumer Cardura PS Pfizer Laboratories Div Pfizer Inc ORAL Duration 2.00 MG TOTAL: DAILY: ORAL Baclofen 60.00 MG 22-Aug-2005 Page: 94 12:15 PM SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report TOTAL: QID: ORAL Ativan Macrodantin Plendil C C C Date:03/30/01ISR Number: 3706283-5Report Type:Expedited (15-DaCompany Report #PHHO2000DE01410 Age:58 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged INTRAVENOUS PT Report Source Product Role Aphasia Epilepsy Foreign Study Health Sandoglobulin Or Placebo (Placebo Placebo) PS Manufacturer Route QMO, Professional INTRAVENOUS Other Baclofen (Baclofen) Ds-103-282 (Tizanidine Hydrochloride) Orfiril (Valproate Sodium) Neuromet (Oxiracetam) SS SS C C Date:04/02/01ISR Number: 3694560-6Report Type:Expedited (15-DaCompany Report #PHBS2000CA08880 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 5 MG, TID, PT Report Source Product Role Manufacturer Route Cerebrovascular Accident Confusional State Foreign Health Lioresal PS Novartis Pharmaceuticals Corp ORAL Disorientation Professional ORAL Other Date:04/03/01ISR Number: 3695879-5Report Type:Expedited (15-DaCompany Report #PHBS2001CA03213 Age: Gender:Unknown I/FU:I Outcome Dose Duration Life-Threatening PT Report Source Product Role Manufacturer Route Gastric Haemorrhage Foreign Health Lioresal PS Novartis Pharmaceuticals Corp ORAL 60 MG/DAY, Professional ORAL Other Date:04/03/01ISR Number: 3696156-9Report Type:Expedited (15-DaCompany Report #PHEH2001US01929 Age:2 YR Gender:Male I/FU:F Outcome Dose Duration Life-Threatening Hospitalization ORAL Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 95 12:15 PM PT Report Source Product Role Manufacturer Route Accidental Overdose Body Temperature Health Professional Lioresal PS Novartis Pharmaceuticals Corp ORAL Decreased Bradycardia Coma Convulsion Drug Level Above Therapeutic Hypothermia Lethargy Respiratory Depression FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/04/01ISR Number: 3700039-5Report Type:Expedited (15-DaCompany Report #01-0396 Age:54 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 20 MG PO QID PT Report Source Product Role Manufacturer Route Anorexia Condition Aggravated Consumer Baclofen PS Watson Laboratories Inc Dry Mouth Baclofen SS Qualitest ORAL Headache Multiple Sclerosis Baclofen SS Schein Pharmaceuticals ORAL Nausea Paraesthesia Topamax Ms Tegretol & Klonopin Fioriceet Demerol Phenergan Ditropan Route 20 MG PO QID 20 MG QID PO C C C C C C Date:04/05/01ISR Number: 3699720-6Report Type:Expedited (15-DaCompany Report #PHBS2001GB03223 Age:36 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 10 MG/ADY PT Report Source Product Role Manufacturer Aspartate Aminotransferase Foreign Literature Lioresal PS Novartis Pharmaceuticals Corp Increased Blood Creatine Health Professional Amitriptyline (Amitriptyline) SS 50 MG/DAY Phosphokinase Increased Blood Lactate Dehydrogenase Increased Depressed Level Of Consciousness Drug Withdrawal Syndrome Hyperhidrosis Leukocytosis Muscle Rigidity Neuroleptic Malignant Syndrome Pyrexia Tachycardia Date:04/05/01ISR Number: 3700147-9Report Type:Direct Age:68 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 10 MG TID PT Company Report # Report Source Hypoglycaemia Lethargy Product Role Phenytoin Baclofen PS SS Warfarin Insulin Gemfibrozil Carvedilol C C C C Manufacturer Route Route Date:04/23/01ISR Number: 3708764-7Report Type:Expedited (15-DaCompany Report #01-0580 Age:60 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 10 MG - 20 MG PT Report Source Product Role Manufacturer Ammonia Increased Asthenia Health Professional Baclofen PS Watson Laboratories Inc Zoloft Prevacid C C Coma TID (SEE Difficulty In Walking TEXT) Disorientation Lethargy 22-Aug-2005 Page: 96 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/25/01ISR Number: 3710988-XReport Type:Expedited (15-DaCompany Report #PHBS2001AU03911 Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Aggression Choking Foreign Consumer Lioresal PS Novartis Pharmaceuticals Corp ORAL Dysphagia Hallucination Tongue Oedema Other Diazepam Clonazepam Clonidine (Clonidine) Temazepam Sulfamethoxazole (Sulfamethoxazole) Duphalac Coloxyl With Senna (Sennoside A+B) Memantine (Memantine) Ergocalciferol Alendronate Serenase C C C C C C C C C C C Date:04/30/01ISR Number: 3715017-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB01322 Age:59 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Condition Aggravated Drug Withdrawal Syndrome Foreign Health Lioresal PS Novartis Pharmaceuticals Corp ORAL Ileus Paralytic Professional Paranoia Other Duration 30 MG, TID, ORAL Diazepam Tramadol (Tramadol) Ranitidine (Ranitidine) Warfarin (Warfarin) Carbamazepine Dantrolene (Dantrolene) C C C C C C Date:05/01/01ISR Number: 3714490-0Report Type:Direct Age:44 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Baclofen (10mg Tab) PS Manufacturer Route Route Duration Face Oedema Swelling Date:05/10/01ISR Number: 3720659-1Report Type:Direct Age:38 YR Gender:Male I/FU:I Outcome PT Dose Duration Life-Threatening Accidental Overdose Hospitalization Bradycardia Initial or Prolonged Hyporeflexia Required Hypotension Intervention to Respiratory Disorder INTRATHECAL 4.17MCG. Prevent Permanent HOUR Impairment/Damage INTRATHECAL 22-Aug-2005 Page: 97 Company Report # 12:15 PM Company Report # Report Source Product Role Manufacturer Lioresal Intrathecal / 10mg/ 20cc / Novartis For Medtronic PS Novartis For Medtronic Medtronic Synchromed Pump C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/11/01ISR Number: 3722392-9Report Type:Expedited (15-DaCompany Report #PHBS2001AU03911 Age:51 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 100 MG/DAY, PT Report Source Product Role Manufacturer Route Aggression Choking Foreign Health Lioresal PS Novartis Pharmaceuticals Corp ORAL Dysarthria Professional Dysphagia Hallucination Tongue Oedema Other Route ORAL Diazepam Clonazepam Clonidine (Clonidine) Temazepam Sulfamethoxazole (Sulfamethoxazole) Duphalac Coloxy With Senna (Sennoside A+B) Memantine (Memantine) Erogcalciferol Alendronate Serenase C C C C C C C C C C C Date:05/14/01ISR Number: 3724028-XReport Type:Expedited (15-DaCompany Report #20010820 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Coma INTRATHECAL 0.025 MCG, Initial or Prolonged Hepatocellular Damage DAILY, Renal Failure Acute INTRATHECAL 1 DAY Report Source Product Role Manufacturer Foreign Lioresal PS Medtronic Inc Health Professional Modopar (Levodopa, Benserazide Hydrochloride) Myolastan (Tetrazapam) Deroxat Urbanyl (Clobazam) Rivotril C C C C C Durogesic (Fentanyl) Transtherapeutic System Forlax (Macrogol) C C Date:05/17/01ISR Number: 3724859-6Report Type:Expedited (15-DaCompany Report #01-0396 FOL.#1 Age:54 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 20 MG PO QID PT Report Source Product Role Manufacturer Route Anorexia Asthenia Consumer Baclofen PS Watson Laboratories Inc ORAL Condition Aggravated Dry Mouth Baclofen 10 Mg, Qualitest SS Qualitest ORAL Face Oedema Headache Baclofen SS Schein Pharmaceuticals ORAL Multiple Sclerosis Nausea Pain Paraesthesia Weight Increased Topamax ... Tegretol Klonopin Fioricet Demerol Phenergan 2 MG PO QID 20 MG QID PO 22-Aug-2005 Page: 98 12:15 PM C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ditropan Oxybutynin Promethazine Meperidine Potassium Furosemide Alprazolam .. Pevacid ... Imitrex Injection Neurontin C C C C C C C C C C C C Date:05/21/01ISR Number: 3726917-9Report Type:Expedited (15-DaCompany Report #PHBS2001DE04906 Age:25 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Overdose Sleep Apnoea Syndrome Foreign Literature Lioresal PS Novartis Pharmaceuticals Corp Product Role Manufacturer Route Lioresal 2000 Mcg/Ml PS Manufacturer Route Duration 40 MG/D Health Professional Other Date:05/23/01ISR Number: 3727480-9Report Type:Direct Age:44 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Medication Error INTRATHECAL 180MCG 1 DAY Initial or Prolonged INTRATHECAL Date:05/23/01ISR Number: 3727772-3Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose PT Duration Company Report # Report Source Company Report # Report Source Product Role Required 20MG BID GT Intervention to PRIOR TO Prevent Permanent ADMISSION Impairment/Damage Alanine Aminotransferase 22-Aug-2005 Page: 99 12:15 PM PS Acetaminophen C Increased Aspartate Aminotransferase Increased Blood Alkaline Phosphatase Increased Blood Creatine Phosphokinase Increased Date:05/23/01ISR Number: 3727773-5Report Type:Direct Age:18 YR Gender: I/FU:I Outcome Dose Duration Required 10MG QID Intervention to Prevent Permanent Impairment/Damage Baclofen (10mg) PT Company Report # Report Source Product Role Alanine Aminotransferase Baclofen 10mg PS Increased Aspartate Aminotransferase Increased Blood Lactate Dehydrogenase Increased Solu-Medrol Propranolol Hazepam Clonidine C C C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/29/01ISR Number: 3729550-8Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization DOSE UNKNOWN Initial or Prolonged PO X 1 Required Intervention to Prevent Permanent Impairment/Damage PT Company Report # Report Source Coma Product Role Baclofen PS Gabapentin Clonazepam Buspirone Alprazolam Diazepam C C C C C Manufacturer Route ORAL Drooling Dyskinesia Medication Error Speech Disorder Urinary Incontinence Vomiting Date:06/04/01ISR Number: 3733094-7Report Type:Expedited (15-DaCompany Report #PHEH2001US02961 Age:15 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 30 MG, TID, PT Report Source Product Role Manufacturer Route Extravasation Medication Error Health Professional Lioresal PS Novartis Pharmaceuticals Corp ORAL Route ORAL; 30 MG, ONCE/SINGLE Date:06/07/01ISR Number: 3734646-0Report Type:Direct Age:44 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Coma Initial or Prolonged Medication Error INTRATHECAL 2000 MG/ML Other 4X5 ML Company Report # Report Source Product Role Manufacturer Baclofen (Lioresal 2000mg / Ml) PS Novartis Lioresal 500mg/Ml (Baclofen) SS Novartis AMPULES INTRATHECAL 500 MG/ML 20ML AMPULE Date:06/11/01ISR Number: 3737262-XReport Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Company Report #2000-09-1047 PT Report Source Product Role Manufacturer Route Drug Interaction Skin Disorder Consumer Claritin PS Schering Corp Sub Schering Plough Corp ORAL Duration 10 MG/QD ORAL Zanaflex (Tizanidine Hcl) Tablets SS Dantrium SS Procardia SS Docusate Sodium SS Senokot Baclofen SS SS Milk Of Magnesia SS Simethicone SS Entex La Tablets SS ORAL 4-8 MG/PRN ORAL 25 MG/TID 10 MG/TID ORAL 1/2-2 TSP/BID ORAL 20 MG/QID 2 TBS/Q3D 80-160 MG/QID 1/2 TAB/QID Date:06/11/01ISR Number: 3740489-4Report Type:Periodic Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Hypoventilation INTRATHECAL UNK MCG, Initial or Prolonged Sedation DAILY, 22-Aug-2005 Page: 100 12:15 PM Company Report #20010823 Report Source Product Role Manufacturer Health Lioresal PS Medtronic Inc Professional Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report INTRATHECAL Date:06/15/01ISR Number: 3740755-2Report Type:Expedited (15-DaCompany Report #PHBS2001DE04906 Age:25 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Nightmare Overdose Foreign Literature Lioresal PS Novartis Pharmaceuticals Corp Sleep Apnoea Syndrome Sleep Attacks Sleep Disorder Health Professional Other Route Duration 40 MG/D Date:06/15/01ISR Number: 3740882-XReport Type:Expedited (15-DaCompany Report #PHEH2001US04787 Age: Gender: I/FU:I Outcome Dose Disability Other INTRATHECAL PT Report Source Product Role Manufacturer Consumer Lioresal PS Novartis Pharmaceuticals Corp Route Duration Anxiety Emotional Disorder INTRATHECAL Injury Medication Error Date:06/20/01ISR Number: 3743119-0Report Type:Expedited (15-DaCompany Report #01-0396 FOL.#2 Age:54 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 20 MG PO QID PT Report Source Product Role Manufacturer Route Anorexia Anxiety Consumer Baclofen PS Watson Laboratories Inc ORAL Asthenia Condition Aggravated Baclofen Tablets 10 Mg, Qualitest SS Drug Effect Decreased Dry Mouth Face Oedema Headache Baclofen Tablets 20 Mg, Schein Pharmaceuticals SS ORAL 20 MG PO QID 20 MG QID PO Schein Pharmaceuticals ORAL Multiple Sclerosis Nausea Paraesthesia Weight Increased Topamax Tegregol Klonopin Fioricet Demerol Phenergan Ditropan Oxybutynin Promethazine Meperidine Potassium Furosemide Alprazolam Baclofen Prevacid Clonazepam Imitrex Injection Neurontin Date:06/26/01ISR Number: 3748127-1Report Type:Expedited (15-DaCompany Report #031-0945-M0100017 Age: Gender:Female I/FU:I Outcome Other 22-Aug-2005 Page: 101 PT Drug Interaction Loss Of Consciousness 12:15 PM Report Source Foreign Health C C C C C C C C C C C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Dose Product Role Manufacturer Route Neurontin PS Pfizer Inc ORAL Baclofen (Baclofen) SS Duration PER ORAL ORAL PER ORAL Date:06/28/01ISR Number: 3749867-0Report Type:Expedited (15-DaCompany Report #20010826 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Hypotonia INTRATHECAL UNK MCG DAILY Initial or Prolonged Medication Error INTRATHECAL Required Overdose Intervention to Pocket Erosion Prevent Permanent Impairment/Damage Report Source Product Role Manufacturer Health Lioresal PS Medtronic Inc Route Professional Date:06/28/01ISR Number: 3750110-7Report Type:Expedited (15-DaCompany Report #PHRM2000FR01837 Age:80 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening Hospitalization 15 MG/DAY, Initial or Prolonged ORAL Other PT Report Source Product Role Manufacturer Route Drug Interaction International Normalised Foreign Health Lioresal PS Novartis Pharmaceuticals Corp ORAL Ratio Increased Professional Other Coumadine (Warfarin Sodium) Tablet SS ORAL Gardenal "Specia" (Phenobarbital)Table t SS ORAL 5 MG/DAY, ORAL 50 MG/DAY, 3 DAY ORAL 3 DAY Date:06/29/01ISR Number: 3750713-XReport Type:Expedited (15-DaCompany Report #2012485 Age: Gender:Male I/FU:I Outcome Dose Duration Other 40 MG PO Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Coma Health Oxycontin PS Purdue Pharma Lp ORAL Professional Company Representative Baclofen (Lioresal) SS Date:07/02/01ISR Number: 3751328-XReport Type:Expedited (15-DaCompany Report #PHFR2001GB01825 Age:82 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 10 MG, TID, PT Report Source Product Role Manufacturer Route Agitation Confusional State Foreign Health Lioresal PS Novartis Pharmaceuticals Corp ORAL Drug Withdrawal Syndrome Professional Hallucination, Visual Other ORAL 22-Aug-2005 Page: 102 12:15 PM Lisinopril (Lisinopril) Fursemid Allopurinol C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/13/01ISR Number: 3758525-8Report Type:Expedited (15-DaCompany Report #PHFR2001GB01980 Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening PT Report Source Product Role Manufacturer Route Apnoea Cheyne-Stokes Respiration Foreign Health Lioresal PS Novartis Pharmaceuticals Corp ORAL Drug Interaction Professional 5 MG, BID, ORAL (SEE Other IMAGE) Enalapril (Enalapril) Atenolol Nortriptyline (Nortriptyline) Co-Dydramol (Dihydrocodeine Bitartrate, Paracetamol) C C C C Date:07/16/01ISR Number: 3759890-8Report Type:Expedited (15-DaCompany Report #PHBS2001ES06967 Age:35 YR Gender:Female I/FU:I Outcome Dose Disability PT Report Source Product Role Manufacturer Route Optic Atrophy Papilloedema Foreign Health Lioresal PS Novartis Pharmaceuticals Corp ORAL Professional Other Neurontin (Gabapentin) Paroxetine Omeprazole Levothroid Route Duration ORAL Date:07/23/01ISR Number: 3763107-8Report Type:Periodic Age:59 YR Gender:Female I/FU:I Outcome Dose Other C C C C Company Report #01-04-0187 PT Report Source Product Role Manufacturer Face Oedema Consumer Baclofen PS Zenith Goldline Duration Hypoaesthesia Oral Pharmaceuticals ORAL 20 MG BID Polyuria ORAL Sleep Disorder Neurontin Prozac Prempro Calcium Qd Magnesium Qd Zinc Qd Multivitamins C C C C C C C Date:07/23/01ISR Number: 3763620-3Report Type:Expedited (15-DaCompany Report #034-0945-M0100007 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 100 MG TID, Initial or Prolonged PER ORAL Other 10 MG TID, PT Report Source Product Role Manufacturer Route Optic Atrophy Foreign Neurontin PS Pfizer Inc ORAL Papilloedema Health Baclofen (Baclofen) SS ORAL Paroxetine (Paroxetine) SS ORAL Omeprazol (Omeprazole) SS ORAL Professional PER ORAL 20 MG (20 MG, DAILY), PER ORAL 20 MG (20 MG, 22-Aug-2005 Page: 103 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report DAILY), PER ORAL Levothyroxine (Levothyroxine) SS ORAL 100 MG (100 MG, DAILY), PER ORAL Date:07/24/01ISR Number: 3764144-XReport Type:Expedited (15-DaCompany Report #PHNU2001DE01547 Age:40 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 635 Initial or Prolonged MICROGRAM; PT Report Source Product Role Coagulopathy Convulsion Health Professional Lioresal (Baclofen) Solution PS Drug Level Below Other Manufacturer Route Manufacturer Route Therapeutic DAY Drug Withdrawal Syndrome Medication Error Multi-Organ Failure Muscle Spasms Insulin Basal (Insulin Isophane Human Semisynthetic) Magnesium Rivotril (Clonazepam) Benzodiazephines C C C C Date:07/24/01ISR Number: 3764147-5Report Type:Expedited (15-DaCompany Report #PHBS2001NL07024 Age:54 YR Gender:Female I/FU:I Outcome PT Dose Duration Life-Threatening Coma Hospitalization Drug Interaction Initial or Prolonged INTRATRACHEAL 0.05 MG, DAY; Report Source Product Role Health Professional Other Lioresal Intrathecal (Baclofen) Solution For Injection PS INJECTION NOS Gabapentin (Gabapentin) Tablet SS Carbasalate Calcium Galenic/Amoxicillin/ Clavulanic Acid (Amoxicillin, Clavulanic Acid) Fentanyl Flucloxacillin Nadroparin Insulin Morphine Sulfate Paracetamol Metoprolol Morphine C ORAL 3 TABLETS, DAY; ORAL C C C C C C C C C Date:07/24/01ISR Number: 3764171-2Report Type:Expedited (15-DaCompany Report #20010833 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Decubitus Ulcer Initial or Prolonged Drug Withdrawal Syndrome INTRA-ARTICULAR MCG, DAILY, Required Implant Site Reaction INTRATHECAL Intervention to Mental Disorder Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 104 12:15 PM Report Source Product Role Manufacturer Health Professional Lioresal (Baclofen Injection) PS Medtronic Inc Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/24/01ISR Number: 3764173-6Report Type:Expedited (15-DaCompany Report #20010832 Age: Gender: I/FU:I Outcome PT Dose Duration Life-Threatening Drug Withdrawal Syndrome INTRATHECAL 635 MCG, Hospitalization Multi-Organ Failure DAILY, Initial or Prolonged INTRATHECAL Report Source Product Role Manufacturer Health Lioresal PS Medtronic Inc Exclude Treatment Of Event C Route Professional Date:07/24/01ISR Number: 3764174-8Report Type:Expedited (15-DaCompany Report #20010831 Age: Gender: I/FU:I Outcome PT Dose Duration Hospitalization Coma INTRATHECAL 50 MCG, Initial or Prolonged Drug Interaction DAILY, Report Source Product Role Manufacturer Health Lioresal PS Medtronic Inc Route Professional INTRATHECAL Date:07/24/01ISR Number: 3764270-5Report Type:Expedited (15-DaCompany Report #20010834 Age: Gender:Female I/FU:I Outcome Dose INTRATHECAL PT Report Source Product Role Manufacturer Foreign Lioresal PS Medtronic Inc Duration Complications Of Maternal MCG, DAILY, Exposure To Therapeutic Health INTRATHECAL Drugs Convulsion Neonatal Drug Withdrawal Syndrome Neonatal Professional Route Date:07/25/01ISR Number: 3765648-6Report Type:Expedited (15-DaCompany Report #PHRM2001FR1687 Age:88 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 10 MG, BID, PT Report Source Product Role Manufacturer Route Agitation Hepatitis Foreign Health Lioresal PS Novartis Pharmaceuticals Corp ORAL Vomiting Professional ORAL Other Prepulsid (Cisapride) SS ORAL Noctamid (Lormetazepam) SS ORAL Ogast (Lansoprazole) SS ORAL 10 MG, TID, ORAL 1 MG, QD, ORAL 30 MG, QD, ORAL Date:07/26/01ISR Number: 3765465-7Report Type:Expedited (15-DaCompany Report #01-07-0392 Age:43 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Blood Creatine Phosphokinase Increased Literature Baclofen PS Zenith Goldline Pharmaceuticals ORAL Duration ORAL Oedema Peripheral Doxepin Tablets SS Pain In Extremity Methadone Hydromorphone C C 100MG HS ORAL 22-Aug-2005 Page: 105 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/26/01ISR Number: 3766327-1Report Type:Expedited (15-DaCompany Report #031-0945-M0100017 Age: Gender:Female I/FU:F Outcome Dose Other PER ORAL PT Report Source Product Role Manufacturer Route Drug Interaction Foreign Neurontin PS Pfizer Inc ORAL Loss Of Consciousness Health Baclofen SS Professional Insuline (Insulin Human) Dantroleen Morfine Sulfate Paracetamol Metoprolol Cabasalate Calcium Flucloxacilline Augmentin (Clavulanate Potassium, Amoxicillin Trihydrate) Nadroparine Duration ORAL PER ORAL C C C C C C C C C Date:07/27/01ISR Number: 3766908-5Report Type:Expedited (15-DaCompany Report #2012485 Age: Gender:Male I/FU:F Outcome Dose Duration Life-Threatening 40 MG Q8H PO Other 20 MG TID PO Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Route Apnoea Health Oxycontin PS Purdue Pharma Lp ORAL Coma Professional Baclofen (Lioresal) SS Delirium Drug Withdrawal Syndrome Hypotension Company Representative Paxil (Paroxetine) Lansoprazole Detrol La (Tolterodine Tartrate) Actos (Pioglitazone) C C Date:07/30/01ISR Number: 3768763-6Report Type:Expedited (15-DaCompany Report #PHBS2001CA03353 Age:58 YR Gender:Female I/FU:I C C ORAL Outcome Dose Duration Death Life-Threatening SEE IMAGE Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Coma Completed Suicide Foreign Health Lioresal PS Novartis Pharmaceuticals Corp ORAL Depressed Level Of Consciousness Hypoxic Encephalopathy Intentional Misuse Pupillary Reflex Impaired Respiratory Arrest Professional Other Pentoxifylline (Pentoxifylline) Route C Date:07/31/01ISR Number: 3768548-0Report Type:Expedited (15-DaCompany Report #20010842 Age: Gender: I/FU:I Outcome Dose Death 50 MCG TEST PT Report Source Product Role Manufacturer Convulsion Health Lioresal PS Medtronic Inc Oral Baclofen C Duration Professional DOSE, INTRATHECAL 22-Aug-2005 Page: 106 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/06/01ISR Number: 3771463-XReport Type:Direct Age:15 YR Gender:Male I/FU:I Outcome PT Dose Duration Life-Threatening Cardio-Respiratory Arrest INTRATHECAL 1000MICRO DAY Hospitalization Medication Error INTRATHECAL Initial or Prolonged Respiratory Depression Required Intervention to Prevent Permanent Impairment/Damage Company Report # Report Source Product Role Manufacturer Route Baclofen PS Manufacturer Route Role Manufacturer Route PS Medtronic Date:08/08/01ISR Number: 3773296-7Report Type:Expedited (15-DaCompany Report #01-1110 Age:18 YR Gender:Male I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent Impairment/Damage APPROXIMATELY PT Report Source Product Role Coma Health Professional Baclofen Tablets, Unknown Manufacturer/Strengt h PS 9 TABLETS Date:08/08/01ISR Number: 3783894-2Report Type:Direct Age:48 YR Gender:Female I/FU:I Outcome Dose INTRATHECAL PT Company Report # Report Source Product Duration Condition Aggravated Failure Of Implant 350 MCG./ Hypertonia Lioresal Mcg./Cc 2000 Medtronic INTRATHECAL Pruritus Baclofen Diazepam Benadryl Vistaril Atarax C C C C C Date:08/09/01ISR Number: 3773028-2Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Other 20 TID PO PT Company Report # Report Source Product Role Baclofen PS Mexitil C Manufacturer Route Duration Cough 2 ORAL MON Date:08/09/01ISR Number: 3775068-6Report Type:Expedited (15-DaCompany Report #PHBS2001JP06832 Age:65 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Constipation Eosinophilia Foreign Health Diovan PS Novartis Pharmaceuticals Corp ORAL Face Oedema Professional Haemorrhage Subcutaneous Headache Other Duration 80 MG/DAY, ORAL Luvox(Fluvoxamine Maleate) SS ORAL Malaise Evamyl(Lormetazepam) SS ORAL Nasal Congestion Petechiae Lioresal (Baclofen, Baclofen) Unknown SS ORAL 50 MG/DAY, Hyponatraemia ORAL 1G/DAY, ORAL 10 MG/DAY, Pyrexia ORAL Bufferin (Aluminum Glycinate, Magnesium 22-Aug-2005 Page: 107 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Carbonate) Ruefrien (Levoglutamide, Azulene) Danoil Sennosides A+B (Sennoside A+B) C C C C Date:08/14/01ISR Number: 3777357-8Report Type:Expedited (15-DaCompany Report #20010844 Age: Gender:Female I/FU:I Outcome Dose Death INTRATHECAL PT Report Source Product Role Manufacturer Health Lioresal PS Medtronic Inc Route Duration Completed Suicide MCG, DAILY, Professional INTRATHECAL Date:08/20/01ISR Number: 3781176-6Report Type:Expedited (15-DaCompany Report #20010846 Age: Gender:Female I/FU:I Outcome Dose Death INTRATHECAL PT Report Source Product Role Manufacturer Health Lioresal PS Medtronic Inc Oral Baclofen C Route Duration Cardiac Arrest 975 MCG, Vomiting Professional DAILY, INTRATHECAL Date:08/28/01ISR Number: 3783895-4Report Type:Direct Age:31 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Drug Withdrawal Syndrome INTRATHECAL 200MCG/DAY Initial or Prolonged Infected Skin Ulcer INTRATHECAL Required Intervention to Company Report # Report Source Product Role Lioresal 2000 Mcg PS Baclofen Diazepam C C Manufacturer Route Prevent Permanent Impairment/Damage Benadryl C Date:08/29/01ISR Number: 3784137-6Report Type:Expedited (15-DaCompany Report #20010852 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL PT Chills Decubitus Ulcer Heart Rate Increased MCG, DAILY, Injection Site Infection Report Source Product Role Foreign Health Professional Lioresal (R) Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route INTRATHECAL Pruritus Pyrexia Date:09/06/01ISR Number: 3788553-8Report Type:Direct Age:11 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Body Temperature Initial or Prolonged Increased INTRATHECAL INTRATHECAL Required Headache 50MCG Intervention to Sedation Prevent Permanent Vomiting Impairment/Damage 22-Aug-2005 Page: 108 12:15 PM Company Report # Report Source Product Role Lioresal (Intrathecal) PS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/11/01ISR Number: 3791461-XReport Type:Expedited (15-DaCompany Report #PHBS2001JP06832 Age:65 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Constipation Diabetes Mellitus Foreign Health Diovan (Valsartan) Tablet PS ORAL Dysuria Professional Eosinophilia Face Oedema Other Luvox(Fluvoxamine Maleate) SS ORAL Haemorrhage Subcutaneous Evamyl(Lormetazepam) SS ORAL Hypertension Hypertonia Lioresal(Baclofen, Baclofen) Unknown SS ORAL Duration 80 MG/DAY, ORAL 50MG/DAY, Gastritis ORAL 1 G/DAY, ORAL 10 MG/DAY, Hyponatraemia ORAL Insomnia Malaise Nasal Congestion Petechiae Pyrexia White Blood Cell Count Decreased Date:09/13/01ISR Number: 3792940-1Report Type:Direct Age:75 YR Gender:Female I/FU:I Outcome Dose Other PO PT Bufferin (Aluminium Glycinate, Magnesium Carbonate) Ruefrien (Levoglutamide, Azulene) Daonil Sennosides A+B (Sennoside A+B) C C C C Company Report # Report Source Product Role Baclofen PS Manufacturer Route Duration Confusional State Delirium Dialysis Renal Failure Chronic ORAL Date:09/24/01ISR Number: 3798599-1Report Type:Expedited (15-DaCompany Report #PHBS2001JP06832 Age:65 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Cerebral Infarction Constipation Foreign Health Diovan (Valsartan) Tablet PS ORAL Dermatitis Professional Diabetes Mellitus Dysuria Other Luvox (Fluvoxamine Maleate) SS ORAL Gastritis Haemorrhage Subcutaneous Evamyl (Lormetazepam) SS ORAL Headache Hemiplegia Lioresal (Baclofen, Baclofen) Unknown SS ORAL Duration 80 MG/DAY, ORAL 50 MG/DAY, Eosinophilia ORAL 1 G/DAY, ORAL 10 MG/DAY, Hypertension ORAL Hypertonia Hyponatraemia Insomnia Malaise Nasal Congestion Pyrexia 22-Aug-2005 Page: 109 12:15 PM Bufferin (Aluminium Glycinate, Magnesium Carbonate) Ruefrien (Levoglutamide, Azulene) Daonil Sennosides A+B (Sennosides A+B) C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/26/01ISR Number: 3798777-1Report Type:Direct Age:56 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 5 MG QID Initial or Prolonged PT Company Report # Report Source Mental Disorder Product Role Baclofen PS Simavastatin Prevacid Metoprolol Levofloxacin Lorazepam(?) Sertraline Olanzapine(?) Oxycontin Oxycodone C C C C C C C C C Manufacturer Route Manufacturer Route Manufacturer Route Date:10/11/01ISR Number: 3808140-2Report Type:Expedited (15-DaCompany Report #20010857 Age: Gender:Male I/FU:I Outcome Dose Death INTRATHECAL PT Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Tetracaine Morphine C C Duration Cerebral Ischaemia Convulsion MCG, DAILY, Depressed Level Of INTRATHECAL Consciousness Drug Withdrawal Syndrome Myocardial Infarction Shock Tachycardia Date:10/12/01ISR Number: 3809873-4Report Type:Expedited (15-DaCompany Report #2000COU1548 Age:59 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Gastrooesophageal Reflux Disease International Normalised Consumer Coumadin (Crystalline Warfarin Sodium) PS PO Ratio Decreased Neurontin ORAL Prothrombin Time Shortened Transient Ischaemic Attack Trigeminal Neuralgia (Gabapentin) Tegretol (Carbamazepine) Dilantin (Phenytoin Sodium) Ni (Baclofen) Vioxx (Rofecoxib) Lanoxin (Digoxin) Ni Verapamil Lipitor (Atorvastatin Calcium) Ni Other (S) Unspecified Date:10/18/01ISR Number: 3812154-6Report Type:Expedited (15-DaCompany Report #PHBS2001JP06832 Age:65 YR Gender:Female I/FU:F Outcome Other 22-Aug-2005 Page: 110 PT Constipation Dermatitis Diabetes Mellitus Dysuria 12:15 PM SS SS SS SS SS SS SS SS SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Eosinophil Count Increased Eosinophilia Report Source Product Role Face Oedema Foreign Diovan(Valsartan) PS ORAL Gastritis Health Haemorrhage Subcutaneous Hypertension Professional Other Luvox (Fluvoxamine Maleate) SS ORAL Hyponatraemia Evamyl(Lormetazepam) SS ORAL Insomnia Malaise Lioresal(Baclofen, Baclofen) SS ORAL Manufacturer Route Duration 80 MG/DAY, ORAL 50 MG/DAY, Hypertonia ORAL 1 G/DAY, ORAL 10 MG/DAY, Nasal Congestion ORAL Pyrexia White Blood Cell Count Decreased Date:10/19/01ISR Number: 3811476-2Report Type:Direct Age:52 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 10MG PO Q8 Initial or Prolonged PT Delirium Ruefrien (Levoglutamide, Azulene) Daonil Sennosides A+B (Sennoside A+B) Bufferin (Aluminium Glycinate, Magnesium Carbonate) C C C C Company Report # Report Source Product Role Baclofen PS Lansoprazole Oscal Codeine C C C Date:10/23/01ISR Number: 3813827-1Report Type:Expedited (15-DaCompany Report #PHHO2001FR08069 Age:80 YR Gender:Female I/FU:I Manufacturer Route ORAL Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG, BID, PT Report Source Product Role Sedation Urinary Incontinence Foreign Study Trileptal (Trileptal T22413+) Unknown PS Health ORAL Professional Other Zoloft (Sertraline Hydrochloride) Lioresal (Baclofen) Unknown Mopral (Omeprazole) Date:10/24/01ISR Number: 3814930-2Report Type:Expedited (15-DaCompany Report #PHRM2001FR02290 Age:72 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 111 12:15 PM PT C-Reactive Protein Increased Depressed Level Of Consciousness Diarrhoea Hypertension Klebsiella Infection Proteus Infection Pulmonary Embolism Pyrexia SS SS C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation White Blood Cell Count Increased Dose Report Source Product Role Manufacturer Route Foreign Health Lioresal (Baclofen) Tablet, 10 Mg PS ORAL Tanakan (Ginkgo Biloba Extract) SS ORAL L-Thyroxin (Levothyroxine Sodium) SS ORAL Cacit (Citric Acid, Calcium Carbonate) Effervescent Tablet SS ORAL Isoptin (Verapamil Hydrochloirde) Capsule SS ORAL Diovenor (Diosmin) Tablet SS ORAL Peflacine (Pefloxacin Mesilate) C Duration 10 MG, TID, Professional ORAL Other 1 DF, TID, ORAL ORAL 1 DF, QD, ORAL 120 MG, TID, ORAL 600 MG, QD, ORAL Date:10/24/01ISR Number: 3815299-XReport Type:Expedited (15-DaCompany Report #FRA002754 Age:72 YR Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Hospitalization 120 MG TID PO Initial or Prolonged 600 MG QD PO Depressed Level Of Foreign Isoptine PS ORAL Consciousness Health Diovenor SS ORAL Diarrhoea Professional Lioresal SS ORAL Drug Tolerance Decreased Other Tanakan SS ORAL Gait Disturbance Inflammation L Thyroxine Cacit D3 SS SS ORAL Klebsiella Infection Proteus Infection Pulmonary Embolism Pyrexia Sedation Urinary Tract Infection Pefloxacine C 1 UNK TID PO 1 UNK TID PO 1 UNK PO Date:10/31/01ISR Number: 3818971-0Report Type:Expedited (15-DaCompany Report #2000COU1548 Age:59 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Gastrooesophageal Reflux Disease International Normalised Consumer Coumadin (Crystalline Warfarin Sodium) PS PO Ratio Decreased Medication Error Prothrombin Time Shortened Transient Ischaemic Attack Trigeminal Neuralgia 22-Aug-2005 Page: 112 12:15 PM Neurontin (Gabapentin) Tegretol (Carbamazepine) Ni (Baclofen) Vioxx (Rofecoxib) Lanoxin (Digoxin) Ni (Verapamil) SS SS SS SS SS SS Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lipitor(Atorvastatin Sodium) Ni (Other (S) Unspecified) Ni(Baclofen) Dilantin(Phenytoin Sodium) SS SS SS SS Date:10/31/01ISR Number: 3819293-4Report Type:Expedited (15-DaCompany Report #PHFR2001GB01825 Age:82 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 20 MG, TID, Initial or Prolonged ORAL PT Report Source Product Role Agitation Foreign Baclofen PS Cerebral Atrophy Literature Confusional State Drug Withdrawal Syndrome Hallucination, Visual Renal Impairment Health Professional Other Lisinopril (Lisinopril) Fursemid Naproxen Allopurinol C C C C Manufacturer Route ORAL Date:11/05/01ISR Number: 3820744-XReport Type:Expedited (15-DaCompany Report #02657 Age:48 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Completed Suicide Intentional Misuse Literature Clonazepam Baclofen PS SS Manufacturer Route Manufacturer Route Duration Date:11/06/01ISR Number: 3820948-6Report Type:Expedited (15-DaCompany Report #20010866 Age: Gender:Male I/FU:I Outcome Dose Death INTRATHECAL DAILY, PT Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Duration Cardiac Arrest Condition Aggravated 380 MCG, Hypertonia Meningitis INTRATHECAL Mental Impairment Sepsis Baclofen Date:11/12/01ISR Number: 3823676-6Report Type:Expedited (15-DaCompany Report #20010872 Age: Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 113 12:15 PM PT Aspiration Body Temperature Increased Drug Withdrawal Syndrome Enterococcal Bacteraemia Hypertonia Infection Laboratory Test Abnormal Obstructive Airways Disorder Oral Intake Reduced Oxygen Saturation Decreased Post Procedural Complication C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Staphylococcal Infection Wound Infection Dose INTRATHECAL Report Source Product Role Health Professional Lioresal (R) Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route Duration MCG, DAILY, INTRATHECAL Date:11/15/01ISR Number: 3825528-4Report Type:Direct Age:6 YR Gender:Female I/FU:I Outcome PT Dose Duration Life-Threatening Medication Error INTRATHECAL INTRATHECAL Hospitalization Mental Impairment Initial or Prolonged Overdose Respiratory Depression Toxicologic Test Abnormal Company Report # Report Source Product Role Morphine PS Baclofen SS Date:11/16/01ISR Number: 3827865-6Report Type:Expedited (15-DaCompany Report #PHRM2001FR02458 Age:50 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Sinus Bradycardia Foreign Health Lioresal(Baclofen) Tablet PS Duration ORAL ORAL Professional Other Date:11/21/01ISR Number: 3828566-0Report Type:Expedited (15-DaCompany Report #20010885 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization - PT Report Source Product No Adverse Drug Effect Health Lioresal Intrathecal Role Manufacturer Route Initial or Prolonged MCG, DAILY, Professional (Baclofen Injection) PS INTRATHECAL Date:11/26/01ISR Number: 3828466-6Report Type:Expedited (15-DaCompany Report #B0126849A Age:42 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 150MG Per day Initial or Prolonged UNKNOWN PT Report Source Multiple Sclerosis Product Role Manufacturer Route Zyban PS Glaxo Wellcome ORAL Interferon Beta SS Lioresal SS UNKNOWN Date:11/26/01ISR Number: 3828480-0Report Type:Expedited (15-DaCompany Report #B0126849A Age:42 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 150MG Per day Initial or Prolonged UNKNOWN UNKNOWN 22-Aug-2005 Page: 114 12:15 PM PT Multiple Sclerosis Report Source Product Role Manufacturer Route Zyban PS Glaxo Wellcome ORAL Interferon Beta SS Lioresal SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/26/01ISR Number: 3828494-0Report Type:Expedited (15-DaCompany Report #B0126849A Age:42 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 150MG Per day Initial or Prolonged UNKNOWN PT Report Source Multiple Sclerosis Product Role Manufacturer Route Zyban PS Glaxo Wellcome ORAL Interferon Beta SS Lioresal SS UNKNOWN Date:11/26/01ISR Number: 3828508-8Report Type:Expedited (15-DaCompany Report #B0126849A Age:42 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 150MG Per day Initial or Prolonged UNKNOWN PT Report Source Multiple Sclerosis Product Role Manufacturer Route Zyban PS Glaxo Wellcome ORAL Interferon Beta SS Lioresal SS UNKNOWN Date:11/26/01ISR Number: 3828522-2Report Type:Expedited (15-DaCompany Report #B0126849A Age:42 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 150MG Per day Initial or Prolonged UNKNOWN PT Report Source Multiple Sclerosis Product Role Manufacturer Route Zyban PS Glaxo Wellcome ORAL Interferon Beta SS Lioresal SS Manufacturer Route UNKNOWN Date:11/26/01ISR Number: 3829691-0Report Type:Expedited (15-DaCompany Report #20010894 Age: Gender:Male I/FU:I Outcome Dose PT Duration Report Source Product Role Death INTRATRACHEAL Blood Creatine Phosphokinase Increased 967 MCG, Blood Glucose Decreased Health Professional Lioresal Intrathecal (Baclofen Injection) PS See B5 C DAILY, Body Temperature INTRATHECAL Increased Hypoaesthesia Protein Total Increased Date:11/26/01ISR Number: 3829700-9Report Type:Expedited (15-DaCompany Report #990710 Age: Gender:Female I/FU:F Outcome PT Dose Duration Hospitalization Agitation Initial or Prolonged Condition Aggravated INTRATRACHEAL DAILY, Csf White Blood Cell INTRATHECAL Count Positive Hypertonia Procedural Site Reaction Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Date:11/26/01ISR Number: 3830022-0Report Type:Expedited (15-DaCompany Report #2001895 Age: Gender:Female I/FU:I Outcome Life-Threatening Hospitalization Initial or Prolonged 22-Aug-2005 Page: 115 12:15 PM PT Agitation Anxiety Confusional State Drug Withdrawal Syndrome Hyperhidrosis Muscle Contractions Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Involuntary Pyrexia Rhabdomyolysis Dose INTRATHECAL Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route Duration DAILY, INTRATHECAL Date:11/26/01ISR Number: 3830035-9Report Type:Expedited (15-DaCompany Report #20010890 Age: Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization INTRATHECAL DAILY, Initial or Prolonged INTRATHECAL PT Report Source Product Role Blood Creatine Phosphokinase Increased Health Professional Lioresal Intrathecal (Baclofen Injection) PS Culture Urine Positive Drug Withdrawal Syndrome Pyrexia Renal Impairment Rhabdomyolysis White Blood Cell Count Increased Date:11/26/01ISR Number: 3830067-0Report Type:Expedited (15-DaCompany Report #20010892 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Agitation Initial or Prolonged Blood Pressure Diastolic INTRATHECAL 840 MCG, Increased DAILY, Condition Aggravated INTRATHECAL Convulsion Disorientation Headache Heart Rate Increased Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Hyperhidrosis Hypertonia Infection Insomnia Loss Of Consciousness Paraesthesia Pyrexia Respiratory Rate Increased Date:11/26/01ISR Number: 3830278-4Report Type:Expedited (15-DaCompany Report #20010891 Age: Gender:Male I/FU:I Outcome Life-Threatening Hospitalization Initial or Prolonged 22-Aug-2005 Page: 116 12:15 PM PT Agitation Blood Pressure Decreased Condition Aggravated Crying Disseminated Intravascular Coagulation Ecchymosis Electrolyte Imbalance Erythema Grand Mal Convulsion Heart Rate Increased FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypertonia Liver Function Test Abnormal Dose INTRATHECAL Report Source Product Role Health Professional Lioresal Intrathecal(Baclofen Injection) PS Manufacturer Route Manufacturer Route Duration Neuroleptic Malignant Syndrome Pyrexia 350 MG, Rhabdomyolysis DAILY, Streptococcal Infection INTRATHECAL Swelling Tremor White Blood Cell Count Increased Date:11/30/01ISR Number: 3832998-4Report Type:Expedited (15-DaCompany Report #PHBS2001NL11719 Age:70 YR Gender:Male I/FU:I Outcome Dose Death ORAL PT Report Source Product Role Cheyne-Stokes Respiration Foreign Lioresal (Baclofen) PS Hypotension Respiratory Tract Infection Somnolence Health Professional Other Tramadol (Tramadol) Lorazepam Naproxen C C C Duration ORAL Date:12/03/01ISR Number: 3833761-0Report Type:Expedited (15-DaCompany Report #11807 Age:44 YR Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Cardiac Arrest Depressed Level Of Consciousness Grand Mal Convulsion Overdose Literature Health Professional Oxybutynin Generic (Oxybutynin Chloride) Cyclobenzaprine Generic (Cyclobenzaprine) Clorazepate Propoxyphene Amitriptyline Role Duration PS SS SS SS SS Manufacturer Route Baclofen Cisapride Omeprazole Diosmin Glycopyrrolate Flumazenil Diazepam Phenytoin SS SS SS SS SS SS SS SS Date:12/05/01ISR Number: 3834978-1Report Type:Expedited (15-DaCompany Report #20010903 Age: Gender:Female I/FU:I Outcome Dose Death INTRATHECAL PT Coma Drug Withdrawal Syndrome 220 MCG, Somnolence DAILY, INTRATHECAL 22-Aug-2005 Page: 117 Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Duration 12:15 PM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/01ISR Number: 3837502-2Report Type:Direct Age:48 YR Gender:Female I/FU:I Outcome Dose Duration Other ONE PILL QHS PT Company Report # Report Source Abnormal Behaviour Product Role Manufacturer Route Baclofen PS ORAL Ambien 10 Mg SS ORAL Hydrocodone Synthroid Ultram Celexa Ibuprofen Premarin C C C C C C Hallucination ORAL Psychotic Disorder 5-10 MG QHS Sleep Walking ORAL Date:12/12/01ISR Number: 3839452-4Report Type:Expedited (15-DaCompany Report #PHBS2001GR12167 Age: Gender: I/FU:I Outcome Dose Death Other 5 MG, BID, PT Report Source Product Role Difficulty In Walking Hypotonia Foreign Literature Baclofen (Baclofen) (Continued) PS Myocardial Infarction Health Overdose Professional Other Manufacturer Route Manufacturer Route Duration UNKNOWN Date:12/14/01ISR Number: 3840494-3Report Type:Expedited (15-DaCompany Report #EMADSS2001007235 Age:49 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Depressed Level Of Consciousness Foreign Health Risperdal (Tablet) (Risperidone) PS Drug Interaction Professional Duration 1 MG, 1 IN 1 DAY (S), ORAL ORAL Salivary Hypersecretion Other Lioseral (Baclofen) SS ORAL 5 MG, 3 IN 1 DAY (S), ORAL Date:12/17/01ISR Number: 3839290-2Report Type:Expedited (15-DaCompany Report #B0126849A Age:42 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 150MG Per day Initial or Prolonged SUBCUTANEOUS PT Report Source Product Role Manufacturer Route Difficulty In Walking Zyban PS Glaxo Wellcome ORAL Faecal Incontinence Interferon Beta SS Multiple Sclerosis Lioresal SS Urinary Incontinence Paracetamol C Glaxo Wellcome ORAL Manufacturer Route ORAL 3UNIT per day 1000MG Twice per day Date:12/17/01ISR Number: 3840847-3Report Type:Expedited (15-DaCompany Report #2001AP05251 Age:44 YR Gender:Male I/FU:I Outcome Dose Duration Death Life-Threatening 22-Aug-2005 Page: 118 12:15 PM PT Report Source Product Role Cardiac Arrest Completed Suicide Depressed Level Of Consciousness Grand Mal Convulsion Overdose Toxicologic Test Abnormal Literature Health Professional Amitriptyline Omeprazole Propoxyphene Clonazepam Oxybutynin Cyclobenzaprine Baclofen Cisapride Diosmin PS SS SS SS SS SS SS SS SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Glycopyrralate Date:12/18/01ISR Number: 3840807-2Report Type:Direct Age:11 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Body Temperature INTRATHECAL INTRATHECAL Initial or Prolonged Increased 50 MCG Required Headache Intervention to Somnolence Prevent Permanent Vomiting Impairment/Damage SS Company Report # Report Source Product Role Lioresal Intrathecal PS Manufacturer Route Manufacturer Route Date:12/24/01ISR Number: 3844508-6Report Type:Expedited (15-DaCompany Report #PHFR2001GB03410 Age: Gender:Male I/FU:I Outcome Dose Other 20 MG, TID, PT Report Source Product Role Arrhythmia Foreign Lioresal(Baclofen) PS Drug Withdrawal Syndrome Health Gastric Haemorrhage Sepsis Professional Other Duration ORAL ORAL Date:12/28/01ISR Number: 3847123-3Report Type:Expedited (15-DaCompany Report #0311-01(0) Age:14 YR Gender: I/FU:I Outcome Dose Disability 3 TABS DAILY PO PT Report Source Product Role Deafness Tinnitus Vertigo Health Professional Baclofen 10 Mg Tablets, Usp (Unknown) PS Manufacturer Route Duration ORAL Date:12/31/01ISR Number: 3846935-XReport Type:Expedited (15-DaCompany Report #002-0981-M0100666 Age:68 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Asthenia Blood Pressure Increased Foreign Consumer Atorvastatin (Atorvastatin) PS ORAL Cerebrovascular Accident Drug Hypersensitivity (Acetylsalicylic Acid) SS ORAL Fall (Ranitidine) SS ORAL Muscle Spasms Paraesthesia (Conjugated Estrogens) SS ORAL Pruritus (Losartan) SS ORAL (Atenolol) SS ORAL (Amiodarone) SS ORAL (Baclofen) SS ORAL (Citalopram) SS ORAL (Trazodone) SS ORAL (Heparin) SS Duration PER ORAL PER ORAL PER ORAL PER ORAL PER ORAL PER ORAL PER ORAL PER ORAL PER ORAL PER ORAL Date:01/14/02ISR Number: 3852300-1Report Type:Expedited (15-DaCompany Report #20020937 Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Respiratory Arrest Initial or Prolonged INTRATHECAL DAILY, 22-Aug-2005 Page: 119 12:15 PM Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report INTRATHECAL Date:01/17/02ISR Number: 3854196-0Report Type:Expedited (15-DaCompany Report #200210022BFR Age:24 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1000 MG DAILY PT Report Source Product Role Manufacturer Route Bradycardia Drug Interaction Health Professional Ciflox (Ciprofloxacin) PS ORAL Hypotension Other Sirdalud (Tizanidine Hydrochloride) SS ORAL Lioresal (Baclofen) SS ORAL Myolastan (Tetrazepam) SS ORAL Voltarene Zyloric Verospiron Pantozol L!Snesium Melperon Zocor C C C C C C C ORAL Hypotonia Malaise SEE IMAGE SEE IMAGE 75 MG DAILY ORAL Date:01/18/02ISR Number: 3855599-0Report Type:Periodic Age:46 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SUBCUTANEOUS Company Report #PHBS2001US03558 PT Report Source Product Abdominal Pain Jejunostomy Nausea Vomiting Consumer Lioresal (Baclofen) Ampoule Betaseron (Albumin Human, Interferon Beta) Role PS SS SUBCUTANEOUS Verapamil (Verapamil) C Manufacturer Route Trazadone Imodium (Loperamide Hydrochloride) Prilosec (Omeprazole) Percocet (Oxycodone Hydrochloride, Paracetamol) Robaxin (Methocarbamol) Celexa (Citalopram Hydrobromide) Valium Neurontin (Gabapentin) Urecholine (Bethanechol Chloride) Oxycontin (Oxycodone Hydrochloride) 22-Aug-2005 Page: 120 12:15 PM C C C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/18/02ISR Number: 3855600-4Report Type:Periodic Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Accidental Overdose INTRATHECAL 2000 MCG, Initial or Prolonged Hypoventilation INTRATHECAL Somnolence Company Report #PHBS2001US05962 Report Source Product Role Health Lioresal Intrathecal PS Manufacturer Route Manufacturer Route Professional Date:01/18/02ISR Number: 3855871-4Report Type:Expedited (15-DaCompany Report #PHBS2002AU00570 Age:14 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 500 MG, PT Report Source Product Role Apnoea Bradycardia Foreign Literature Baclofen (Baclofen) Tablet PS Brain Oedema Health Coma Professional Convulsion Depressed Level Of Consciousness Drug Screen Positive Encephalitis Headache Hyperhidrosis Hyperreflexia Hypertension Hyporeflexia Lethargy Nausea Overdose Pupil Fixed Vomiting Other ONCE/SINGLE, ORAL Tramadol Hydrochloride (Tramadol Hydrochloride) Aspirine (Acetylsalicylic Acid) Date:01/23/02ISR Number: 3859372-9Report Type:Expedited (15-DaCompany Report #20010903 Age: Gender:Female I/FU:F SS SS ORAL Outcome Dose Death INTRATHECAL PT Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Duration Coma Drug Withdrawal Syndrome 220 MCG, Pneumonitis DAILY, Somnolence INTRATHECAL Date:01/23/02ISR Number: 3859515-7Report Type:Expedited (15-DaCompany Report #20010846 Age: Gender:Female I/FU:F Outcome Dose Death INTRATHECAL PT Report Source Product Role Health Professional Lioresal (Intrathecal (Baclofen Injection) PS Baclofen C Duration Cardiac Arrest Clonic Convulsion Medical Device 975 MCG, Complication DAILY, Pneumonia INTRATHECAL Vomiting Date:01/23/02ISR Number: 3860015-9Report Type:Direct Age:45 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization 22-Aug-2005 Page: 121 12:15 PM Company Report #CTU 159872 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Disability PT Dose Report Source Product Role Manufacturer Lioresal 2000 Mcg./Cc Medtronic PS Medtronic Valium C Route Duration INTRATRACHEAL Cardio-Respiratory Arrest Coma 650 MCG DAY Convulsion INTRATRACHEAL Drug Withdrawal Syndrome Muscle Spasticity Pyrexia Date:01/25/02ISR Number: 3860390-5Report Type:Expedited (15-DaCompany Report #PHRM2002FR00519 Age:24 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 30 MG DAILY, PT Report Source Product Role Manufacturer Route Bradypnoea Drug Interaction Foreign Health Lioresal(Baclofen)Ta blet PS ORAL Hypotension Professional Hypotonia Malaise Other Sirdalud(Tizanidine Hydrochloride) SS ORAL Myolastan(Tetrazepam ) SS ORAL Ciflox(Ciprofloxacin )Tablet SS Voltarene Lp (Diclofenac Sodium) C ORAL 12 MG DAILY, Skin Infection ORAL 75 MG PER DAY, ORAL 1 G DAILY Date:01/29/02ISR Number: 3861185-9Report Type:Expedited (15-DaCompany Report #PHBS2002AR01041 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Depressed Level Of Consciousness Foreign Health Lioresal(Baclofen)Ta blet PS Muscle Contractions Professional Involuntary Other Manufacturer Route Duration ORAL 10 MG, ONCE/SINGLE, ORAL Somnolence Date:01/29/02ISR Number: 3862026-6Report Type:Expedited (15-DaCompany Report #PHBS2002AR01041 Age: Gender:Female I/FU:I Outcome Dose Other 10 MG, PT Report Source Product Role Depressed Level Of Foreign Lioresal (Baclofen) PS Consciousness Health Muscle Contractions Professional Involuntary Somnolence Other Manufacturer Route Duration ORAL ONCE/SINGLE; ORAL Date:01/30/02ISR Number: 3862391-XReport Type:Expedited (15-DaCompany Report #PHEH2002US00956 Age:16 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 122 12:15 PM PT Report Source Product Role Pancreatitis Health Professional Lioresal (Baclofen) PS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/02ISR Number: 3865357-9Report Type:Expedited (15-DaCompany Report #PHRM2001FR01766 Age:31 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL INTRATHECAL PT Report Source Product Role Phlebitis Foreign Health Lioresal (Baclofen) Tablet PS Professional Other Lioresal Inthratecal (Baclofen) Solution For Injection SS Manufacturer Route ORAL 80 MCG/DAY, INTRATHECAL Previscan (Fluindione) Tablet Lysanxia (Prazepam) Tablet Zyrtec (Cetirizine Hydrochloride) C C C Date:02/08/02ISR Number: 3867290-5Report Type:Expedited (15-DaCompany Report #PHBS2002IT01370 Age:56 YR Gender:Male I/FU:I Outcome Dose Death 2 G ONCE PT Report Source Product Role Asphyxia Foreign Baclofen (Baclofen) PS Completed Suicide Literature Cyanosis Drug Toxicity Health Professional Dipyrone (Metamizole Sodium) SS Oxybutynin (Oxybutynin) SS Terazosin (Terazosin) SS Duration SINGLE 20 G ONCE Intentional Misuse SINGLE Petechiae 0.15 G ONCE SINGLE 0.09 G ONCE SINGLE Manufacturer Route Laxatives (No Ingredients/Substanc es) SS Acetylsalicylic Acid (Acetylsalicylic Acid) SS Defibrotide (Defibrotide) C ORAL 40 PILLS ONCE SINGLE 3.3 G ONCE SINGLE 8.4 G ONCE SINGLE Date:02/08/02ISR Number: 3867329-7Report Type:Expedited (15-DaCompany Report #PHRM2002FR00519 Age:24 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 30 MG DAILY, PT Report Source Product Role Manufacturer Route Bradycardia Drug Interaction Foreign Health Lioresal (Baclofen) Tablet PS ORAL Hypotension Professional Hypotonia Malaise Other Sirdalud (Tizanidine Hydrochloride) Unknown SS ORAL Myolastan (Tetrazepam) SS ORAL ORAL 12 MG DAILY, ORAL 75 MG PER DAY, ORAL Ciflox (Ciprofloxacin) 22-Aug-2005 Page: 123 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tablet SS Voltarene Lp (Diclofenac Sodium) C 1 G DAILY Date:02/13/02ISR Number: 3875557-XReport Type:Periodic Age:52 YR Gender:Male I/FU:I Outcome Dose Death Company Report #2012150 PT Report Source Product Role Manufacturer Route Overdose Health Professional Other Oxycodone Hydrochloride (Similar To Nda 20-553) PS ORAL Paroxetine SS ORAL Baclofen (Lioresal) SS Duration PO PO Date:02/13/02ISR Number: 3877776-5Report Type:Periodic Age:46 YR Gender:Male I/FU:I Outcome Dose Death Company Report #2011912 PT Report Source Product Role Manufacturer Route Accidental Overdose Health Professional Company Representative Oxycontin Cr Tablets, 20 Mg (Oxycodone Hydrochloride) PS ORAL Oxycontin Cr Tablets, 40 Mg (Oxycodone Hydrochloride) SS ORAL Baclofen Cocaine SS SS Duration 20 MG BID PO 40 MG BID PO Date:02/19/02ISR Number: 3871971-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB00742 Age:65 YR Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Other Depressed Level Of Consciousness Foreign Health Hyperreflexia Professional Muscle Spasticity Other Baclofen (Baclofen) Unknown PS ORAL 10 MG/DAY, ORAL Gabapentin (Gabapentin) Tramadol (Tramadol) Lisinopril (Lisinopril) Ciprofloxacin (Ciprofloxacin) C C C C Date:02/19/02ISR Number: 3872784-2Report Type:Expedited (15-DaCompany Report #20020950 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Muscle Spasticity Initial or Prolonged Myalgia INTRATHECAL DAILY, Nausea INTRATHECAL Syncope 22-Aug-2005 Page: 124 12:15 PM Report Source Product Role Health Professional Lioresal Intrathecal PS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/21/02ISR Number: 3873324-4Report Type:Expedited (15-DaCompany Report #PHBS2001NL11719 Age:70 YR Gender:Male I/FU:F Outcome Dose Death PT Report Source Product Role Aortic Valve Stenosis Bronchitis Cerebral Ischaemia Cheyne-Stokes Respiration Hypotension Pyrexia Respiratory Tract Infection Somnolence Foreign Health Professional Other Lioresal (Baclofen) Tramadol Lorazepam Naproxen PS C C C Manufacturer Route Duration ORAL Date:02/26/02ISR Number: 3875806-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB00809 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization 2.5 MG/DAY, Initial or Prolonged ORAL PT Report Source Product Role Body Temperature Foreign Baclofen (Baclofen) PS Decreased Health Bradycardia Depressed Level Of Consciousness Hypotonia Somnolence Professional Other Date:02/28/02ISR Number: 3890069-5Report Type:Periodic Age:56 YR Gender:Female I/FU:I Outcome Dose Other Manufacturer Route ORAL Company Report #001-0945-M0100980 PT Report Source Product Dry Mouth Libido Decreased Oedema Peripheral Overdose Pain Weight Increased White Blood Cell Count Consumer Neurontin (Gabapentin) Baclofen Acetylsalicylic Acid, Caffeine Anhdyrous, Butalbital Unknown Role Duration PS SS C Manufacturer Route Chemotherapeutic Agent C Date:03/06/02ISR Number: 3880297-7Report Type:Expedited (15-DaCompany Report #PHBS2002AU02650 Age: Gender:Female I/FU:I Outcome Dose Death ORAL PT Report Source Product Role Completed Suicide Foreign Lioresal(Baclofen) PS Depression Health Professional Other Date:03/12/02ISR Number: 3882125-2Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Other 10MG PO BID Route PT ORAL Company Report #CTU 163293 Report Source Product Role Hallucination Baclofen PS Mental Status Changes Duragesic Patch SS Manufacturer Route Duration 75MCG Q 72H 22-Aug-2005 Page: 125 Manufacturer Duration 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/12/02ISR Number: 3882919-3Report Type:Expedited (15-DaCompany Report #PHBS2002JP03106 Age:60 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1 TABLET/D, PT Report Source Product Role Eosinophilia Lung Infiltration Foreign Health Lioresal (Baclofen) Tablet PS Pneumonia Professional Selegiline Hydrochloride Herbal Extracts C C Manufacturer Route ORAL ORAL Other Date:03/12/02ISR Number: 3882921-1Report Type:Expedited (15-DaCompany Report #PHRM2002FR00857 Age:52 YR Gender:Male I/FU:I Outcome Dose Other INTRATHECAL PT Report Source Product Role Amaurosis Fugax Retinal Vein Thrombosis Foreign Health Professional Lioresal Intrathecal (Baclofen) Solution For Injection PS Manufacturer Route Manufacturer Route Duration 50 UG, Other ONCE/SINGLE, INTRATHECAL Date:03/14/02ISR Number: 3886768-1Report Type:Periodic Age:42 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRAVENOUS Company Report #2002087109US PT Report Source Product Role Delusion Disorientation Hallucination Health Professional Solu-Medrol(Methylpr ednisolone)Powder, Sterile PS IV Psychotic Disorder Baclofen Klonopin (Clonazepam) SS SS Date:03/15/02ISR Number: 3884609-XReport Type:Expedited (15-DaCompany Report #20020981 Age: Gender:Male I/FU:I Outcome PT Dose Duration Life-Threatening Coma Hospitalization Medication Error Initial or Prolonged INTRATHECAL 100 MCG, Required DAILY, Intervention to INTRATHECAL Prevent Permanent Impairment/Damage Report Source Product Role Health Professional Lioresal Intrathecal(Baclofen Injection) PS Manufacturer Route Manufacturer Route Date:03/20/02ISR Number: 3886160-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB00491 Age:73 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Haematemesis Foreign Health Lioresal (Baclofen) Tablet PS Professional Other Ranitidine (Ranitidine) Laxatives (No Ingredients / Substances) Bendrofluazide (Bendroflumethiazide ) Duration 5 MG/DAY, 22-Aug-2005 Page: 126 12:15 PM C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prochlorperazine (Prochlorperazine) C Date:03/20/02ISR Number: 3886166-0Report Type:Expedited (15-DaCompany Report #PHFR2002GB01045 Age: Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Role Jaundice Foreign Health Lioresal (Baclofen) Unknown PS Professional Other Antiepileptics (No Ingredients / Substances) C Manufacturer Route Manufacturer Route Duration 10 MG, TID, Date:03/20/02ISR Number: 3886170-2Report Type:Expedited (15-DaCompany Report #PHBS2002AU02650 Age:47 YR Gender:Female I/FU:F Outcome Dose Death PT Report Source Product Role Completed Suicide Major Depression Foreign Health Lioresal (Baclofen) Tablet PS Cipramil C Duration ORAL 20 MG/DAY, Professional ORAL Other Date:03/28/02ISR Number: 3890215-3Report Type:Expedited (15-DaCompany Report #309913 Age:69 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening PT Coma Confusional State Dyskinesia Hallucination Medication Error Memory Impairment Report Source Product Role Manufacturer Rivotril Temesta Lioresal PS SS SS Roche Route Date:03/28/02ISR Number: 3891135-0Report Type:Periodic Age:49 YR Gender:Male I/FU:F Outcome Dose Company Report #CIP00001154 PT Report Source Product Role Manufacturer Route Clonic Convulsion Cognitive Deterioration Condition Aggravated Health Professional Dantrium (Dantrolene Sodium) Capsule, Unknownmg PS ORAL Baclofen (Baclofen) Tablet SS ORAL Duration 50 MG 3 TIMES Confusional State DAILY; 25 MG Drug Interaction 3 TIMES Dysarthria DAILY; 30 MG Medication Error 3 TIMES Memory Impairment Muscle Spasms 30 MG 3 TIMES Somnolence DAILY, ORAL; Speech Disorder 20 MG 3 TIMES DAILY Norvasc (Amlodipine Besilate) Norpramin (Desipramine Hydrochloride) 22-Aug-2005 Page: 127 12:15 PM C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/02ISR Number: 3893540-5Report Type:Expedited (15-DaCompany Report #309913 Age:69 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening PT Report Source Product Role Manufacturer Route Coma Confusional State Foreign Other Rivotril (Clonazepam) PS ORAL Temesta (Lorazepam) SS ORAL Lioresal (Baclofen) SS 5 UNIT DAILY Dyskinesia ORAL Hallucination ORAL INTRAVENOUS Medication Error INTRAVENOUS Memory Impairment Date:04/02/02ISR Number: 3894029-XReport Type:Expedited (15-DaCompany Report #A206119 Age:50 YR Gender:Male I/FU:F Outcome Dose Duration Required 50.00 MG Intervention to TOTAL:PRN:ORA Prevent Permanent L Impairment/Damage 300.00 MG PT Report Source Product Role Anorgasmia Consumer Viagra Tablets PS Doxepin SS Hydroxyzine Baclofen Seroquel Chloral Hydrate Remeron SS SS C C C Manufacturer Route ORAL Ejaculation Failure Erectile Dysfunction Hypoaesthesia Medication Error TOTAL Overdose Penis Disorder Priapism Date:04/03/02ISR Number: 3895302-1Report Type:Expedited (15-DaCompany Report #PHBS2002PL03764 Age:29 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization - PT Report Source Product Asthenia Foreign Baclofen (Baclofen) Role Manufacturer Route Initial or Prolonged 10 MG, BID Other Fear Literature Loss Of Consciousness Nausea Poisoning Vomiting Health Professional Other Unknown PS Date:04/08/02ISR Number: 3895870-XReport Type:Expedited (15-DaCompany Report #309913 Age:69 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening PT Report Source Coma Confusional State Dyskinesia Hallucination Memory Impairment Product Role Manufacturer Rivotril Temesta Lioresal PS SS SS Roche Manufacturer Route Date:04/08/02ISR Number: 3897791-5Report Type:Expedited (15-DaCompany Report #FR8947603APR2002 Age:69 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening PT Report Source Product Role Coma Confusional State Health Professional Temesta (Lorazepam, Unspec, 0) PS Other Lioresal (Baclofen) SS ORAL INTRAVENOUS Hallucination 1 DOSE 50 Memory Impairment TIMES PER Muscle Contractions DAY, Involuntary INTRAVENOUS Rivotril 22-Aug-2005 Page: 128 12:15 PM Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Clonazepam) SS ORAL 5 DOSES DAILY, ORAL Date:04/10/02ISR Number: 3898289-0Report Type:Expedited (15-DaCompany Report #FR8947603APR2002 Age:69 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening Disability ORAL INTRAVENOUS PT Report Source Product Role Coma Confusional State Health Professional Temesta (Lorazepam, Unspec, 0) PS Other Lioresal (Baclofen) SS Memory Impairment Muscle Contractions Rivotril (Clonazepam) SS Involuntary Astrocytoma C Hallucination 1 DOSE 50 Medication Error Manufacturer Route ORAL TIMES PER DAY ORAL 5 DOSES DAILY Date:04/10/02ISR Number: 3898469-4Report Type:Expedited (15-DaCompany Report #309913 Age:69 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening PT Report Source Product Role Manufacturer Route Coma Confusional State Foreign Other Rivotril (Clonazepam) PS ORAL Temesta (Lorazepam) SS ORAL Lioresal (Baclofen) SS 5 UNIT DAILY Dyskinesia ORAL Hallucination ORAL INTRAVENOUS Medication Error INTRAVENOUS Memory Impairment Date:04/11/02ISR Number: 3899096-5Report Type:Expedited (15-DaCompany Report #20020997 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL PT Report Source Product Role Unevaluable Event Foreign Health Professional Lioresal(R) Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route 100 MCG ONCE INTRATHECAL Date:04/15/02ISR Number: 3901520-6Report Type:Expedited (15-DaCompany Report #A206119 Age:50 YR Gender:Male I/FU:F Outcome Dose Duration Required 50.00 MG Intervention to TOTAL:PRN:ORA Prevent Permanent L Impairment/Damage 300.00 MG PT Report Source Product Role Drug Effect Decreased Consumer Viagra Tablets PS Doxepin SS Hydroxyzine Baclofen Seroquel Chloral Hydrate Remeron (Subject Drug) SS SS C C Ejaculation Disorder Erectile Dysfunction Priapism TOTAL Date:04/16/02ISR Number: 3902278-7Report Type:Expedited (15-DaCompany Report #PHBS2002CL04226 Age:57 YR Gender:Male I/FU:I Outcome Other 22-Aug-2005 Page: 129 PT Pulmonary Fibrosis 12:15 PM Report Source Foreign Consumer C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other Dose Product Role Lioresal(Baclofen) Tablet PS Enalapril (Enalapril) Diazepam C C Manufacturer Route Duration SEE IMAGE ORAL 1095 DAY Date:04/22/02ISR Number: 3903758-0Report Type:Expedited (15-DaCompany Report #309913 Age:69 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening PT Report Source Coma Confusional State Dyskinesia Hallucination Memory Impairment Product Role Manufacturer Rivotril Temesta Lioresal PS SS SS Roche Manufacturer Route Date:04/23/02ISR Number: 3906120-XReport Type:Expedited (15-DaCompany Report #309913 Age:69 YR Gender:Female I/FU:F Outcome Dose Duration Life-Threatening PT Report Source Product Role Route Coma Confusional State Foreign Other Rivotril (Clonazepam) PS ORAL Hallucination Temesta (Lorazepam) SS ORAL Memory Impairment Lioresal (Baclofen) SS 5 UNIT DAILY Dyskinesia ORAL ORAL INTRADISCAL (INTRASPINAL) PER 50 DAY INTRADISCAL 1 DOSE FORM 1 (INTRASPINAL) Date:04/26/02ISR Number: 3908528-5Report Type:Expedited (15-DaCompany Report #PHBS2002PL03764 Age:29 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization 10 MG, BID Initial or Prolonged 22-Aug-2005 Page: 130 12:15 PM PT Report Source Product Role Accommodation Disorder Foreign Baclofen(Baclofen) PS Anxiety Asthenia Coma Dyspnoea Fear Hypoaesthesia Hypotonia Loss Of Consciousness Nausea Salivary Hypersecretion Somnolence Therapeutic Agent Toxicity Vomiting Literature Health Professional Other Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/06/02ISR Number: 3912132-2Report Type:Expedited (15-DaCompany Report #02-04-0381 Age:55 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization ORAL Initial or Prolonged Other PT Report Source Product Role Manufacturer Route Chromaturia Consumer Baclofen Tablets PS Ipi ORAL Bumex Ditropan Xl C C Manufacturer Route Manufacturer Route Diabetes Mellitus Fatigue Hepatitis Hepatocellular Damage Liver Function Test Abnormal Pancreatic Disorder Pyrexia Swelling Weight Decreased Date:05/06/02ISR Number: 3912537-XReport Type:Expedited (15-DaCompany Report #20021028 Age: Gender:Female I/FU:I Outcome PT Dose Duration Required Drug Withdrawal Syndrome Intervention to INTRATHECAL MCG, DAILY , Prevent Permanent INTRATHECAL Impairment/Damage Date:05/13/02ISR Number: 3916451-5Report Type:Direct Age:48 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Hypersensitivity Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Company Report #CTU 167997 Report Source Product Role Zanaflex Baclofen PS SS Date:05/20/02ISR Number: 3919685-9Report Type:Expedited (15-DaCompany Report #PHRM2002FR01351 Age:66 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 10 MG, QD, PT Report Source Product Role Coma Hypothalamo-Pituitary Foreign Health Lioresal(Baclofen) Tablet PS Disorders Professional Hypotonia Multiple Sclerosis Relapse Nervous System Disorder Other Neurontin (Gabapentin) Aldalix Capsule C C Manufacturer Route ORAL ORAL Date:05/22/02ISR Number: 3922404-3Report Type:Expedited (15-DaCompany Report #PHRM2002FR00857 Age:52 YR Gender:Male I/FU:F Outcome Dose Disability Other INTRATHECAL PT Report Source Product Role Amaurosis Fugax Hypotension Retinal Vein Thrombosis Foreign Health Professional Other Lioresal Intrathecal(Baclofen ) Solution For Injection PS Lioresal "Novartis" (Baclofen) Tablet SS Manufacturer Route Duration 50 MG, ONCE/SINGLE, INTRATHECAL 75 MG/DAY, ORAL Seropram(Citalopram 22-Aug-2005 Page: 131 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hydrovromide) Tablet SS ORAL Tardyferon(Ferrous Sulfate) Tablet SS ORAL Dulcolax(Bisacodyl) SS 20 MG/DAY, ORAL 2 TABS/DAY, ORAL Date:05/23/02ISR Number: 3922620-0Report Type:Expedited (15-DaCompany Report #2002-DE-01032GD (0) Age:38 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Angiogram Abnormal Angiogram Retina Abnormal Blindness Literature Mexiletine (Mexiletine Hydrochloride) PS ORAL Conjunctival Hyperaemia Drug Toxicity Clonidine (Clonidine) SS ORAL Eye Disorder Morphine (Morphine) SS ORAL Fundoscopy Abnormal Maculopathy Retinogram Abnormal Retinopathy Trazodine (Trazodine Hydrochloride) Pentosan Polysulfate (Pentosan Polysulfate) Gabapentin (Gabapentin) Lidocaine Hydrochloride (Lidocaine Hydrochloride) Manufacturer Route DAILY, PO PO PO INTRAVENOUS SS SS SS SS 385.7 MG (SINGLE DOSE INFUSION), IV Baclofen (Baclofen) PO Methadone Hydrochloride (Methadone SS ORAL Hydrochloride) SS PO Lorazepam (Lorazepam) Hydroxyzine Hydrochloride Hydroxyzine Hydrochloride) Glimepiride (Oral Antidiabetics) Promethazine Hydrochloride (Promethazine Hydrochloride) Fluoxetine Hydrochloride (Fluoxetine Hydrochloride) Sucralfate (Sucralfate) Date:05/24/02ISR Number: 3923365-3Report Type:Expedited (15-DaCompany Report #PHNU2001DE02477 Age:30 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization 22-Aug-2005 Page: 132 12:15 PM SS SS SS SS SS SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Dose PT Report Source Product Role Aspiration Bronchial Blood Creatine Foreign Health Lioresal(Baclofen) Tablet, 25mg PS Phosphokinase Increased Professional Blood Creatine Other Manufacturer Route Duration ORAL 1000 MG, ONCE/SINGLE, ORAL Phosphokinase Mb Coma Convulsion Intentional Misuse Date:05/28/02ISR Number: 3924413-7Report Type:Expedited (15-DaCompany Report #2002-DE-01032GD (0) Age:38 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Blindness Retinal Degeneration Retinopathy Scotoma Literature Mexiletine (Mexiletine Hydrochloride) (Nr) (Mexiletine-Hcl) PS ORAL Clonidine (Clonidine) (Nr) (Clonidine-Hcl) SS ORAL Morphine (Morphine) (Nr) (Morphine-Hcl) SS ORAL Manufacturer Route PO Toxicologic Test Abnormal PO PO Trazodone (Trazodone Hydrochloride) (Nr) (Trazodone-Hcl) Pentosan Polysulfate (Pentosan Polysulfate) Gabapentin (Gabapentin) (Nr) Lidocaine Hydrochloride (Lidocaine SS SS SS INTRAVENOUS Hydrochloride) SS Baclofen (Baclofen) (Nr) SS ORAL Methadone Hydrochloride (Methadone Hydrochloride) SS ORAL 385.27 MG (SINGLE DOSE INFUSION) IV PO PO Lorazepam (Lorazepam) (Nr) Hydroxyzine Hydrochloride (Hydroxyzine Hydrochloride) (Nr) Glimepiride (Oral Antidiabetics) (Nr) Promethazine Hydrochloride (Promethazine Hydrochloride) Sucralfate (Sucralfate) (Nr) 22-Aug-2005 Page: 133 12:15 PM SS SS SS SS SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/04/02ISR Number: 3928123-1Report Type:Expedited (15-DaCompany Report #02-04-0381 Age:55 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 10 MG ORAL Other PT Report Source Product Role Chromaturia Diabetes Mellitus Consumer Baclofen - Ipi Tablets PS Bumex Fluid Retention Ditropan Cenestin C C C C Fatigue Gastrointestinal Disorder Hepatitis Hypertension Nasopharyngitis Pancreatic Disorder Pyrexia Swelling Urinary Tract Infection Weight Decreased Date:06/06/02ISR Number: 3928907-XReport Type:Direct Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Agitation INTRATHECAL 100MCG/DAY Initial or Prolonged Confusional State CONTINOUS Muscle Spasticity INTRATHECAL Pyrexia Manufacturer Route ORAL Company Report #CTU 169646 Report Source Product Role Baclofen PS Pediasure Mellaril Albuterol Decadron Mylicon Zyrtec Vancomycin Aminophylline Tegretol Robanul Diamox Reglan Zantac C C C C C C C C C C C C C Manufacturer Route Date:06/12/02ISR Number: 3932877-8Report Type:Expedited (15-DaCompany Report #PHBS2002JP03106 Age:60 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 5 MG/DAY, PT Report Source Product Role Manufacturer Route Eosinophilia Lung Infiltration Foreign Health Lioresal(Baclofen) Tablet PS ORAL Pneumonia Professional Herbal Extracts Nos (No Ingredients/Substanc es) SS ORAL Selegilene Hydrochloride C ORAL Other ORAL Date:06/12/02ISR Number: 3933087-0Report Type:Expedited (15-DaCompany Report #PHBS2002AU05729 Age:41 YR Gender: I/FU:I Outcome Other 22-Aug-2005 Page: 134 PT Alanine Aminotransferase Increased Aspartate 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Aminotransferase Increased Gamma-Glutamyltransferase Increased Dose Report Source Product Role Foreign Lioresal (Baclofen) PS Manufacturer Route Duration ORAL 10 MG, TID, Health ORAL Professional Other Date:06/12/02ISR Number: 3933340-0Report Type:Expedited (15-DaCompany Report #PHBS2002JP03106 Age:60 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 1 TABLET/D, PT Report Source Product Role Manufacturer Route Eosinophilic Pneumonia Lung Infiltration Foreign Health Lioresal(Baclofen) Tablet PS ORAL Pneumonia Professional Selegiline Hydrochloride (Selegiline Hydrochloride) Tablet SS ORAL Herbal Extracts Nos (No Ingredients/Substanc es) SS ORAL ORAL Other ORAL ORAL Date:06/12/02ISR Number: 3933653-2Report Type:Expedited (15-DaCompany Report #PHBS2002JP06406 Age:20 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 120 MG/D, PT Report Source Product Role Hypercapnia Foreign Health Lioresal(Baclofen) Tablet PS Professional ORAL Manufacturer Route ORAL Other Phenobarbital(Phenob arbital) SS Depakene Benzalin C C ORAL 200 MG/D, ORAL Date:06/18/02ISR Number: 3935686-9Report Type:Expedited (15-DaCompany Report #20021066 Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Medical Device Initial or Prolonged Complication INTRATHECAL UNK MCG, Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route DAILY, INTRATHECAL Date:06/18/02ISR Number: 3935689-4Report Type:Expedited (15-DaCompany Report #20021064 Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Csf Test Abnormal Initial or Prolonged Musculoskeletal Stiffness INTRATRACHEAL 50 MCG, ONCE, Pain INTRATHECAL Pyrexia 22-Aug-2005 Page: 135 12:15 PM Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/24/02ISR Number: 3939049-1Report Type:Expedited (15-DaCompany Report #02-04-0381 Age:55 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 10MG ORAL PT Report Source Product Role Manufacturer Route Chromaturia Dehydration Health Professional Baclofen - Ipi Tablets PS Ipi ORAL Bumex Ditropan Cenestin Glucotrol Xl Quinine Sulfate C C C C C Manufacturer Route Diabetes Mellitus Fatigue Gastroenteritis Hepatitis Hepatocellular Damage Hypertension Inflammation Muscle Spasms Nasopharyngitis Oedema Pancreatic Disorder Proteus Infection Urinary Tract Infection Weight Decreased Date:06/26/02ISR Number: 3940300-2Report Type:Expedited (15-DaCompany Report #PHNU2002DE01956 Age:3 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Hypokalaemia Foreign Health Lioresal(Baclofen) Tablet PS Topamax(Topiramate) C Duration ORAL 25 MG, QID, Professional ORAL Other Date:07/01/02ISR Number: 3943008-2Report Type:Expedited (15-DaCompany Report #20021082 Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Gastric Atony Initial or Prolonged Pancreatitis INTRATHECAL 100 MCG, Report Source Product Role Foreign Health Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Required ONCE, Intervention to INTRATHECAL Prevent Permanent Impairment/Damage Professional Sirdalud (Tizanidine Hydrochloride) Lioresal Intrathecal 25 Mcg C C Date:07/03/02ISR Number: 3944385-9Report Type:Expedited (15-DaCompany Report #PHBS2002AU02650 Age:47 YR Gender:Female I/FU:F Outcome Dose Death PT Report Source Product Role Adrenoleukodystrophy Completed Suicide Foreign Health Lioresal(Baclofen) Tablet PS Depression Professional Drug Toxicity Pulmonary Oedema Thyroid Disorder Toxicologic Test Abnormal Other Cipramil C 10 MG, BID, ORAL 22-Aug-2005 Page: 136 Manufacturer Route Duration 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/05/02ISR Number: 3946585-0Report Type:Expedited (15-DaCompany Report #CIP02001062 Age:52 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Dehydration Grand Mal Convulsion Foreign Health Professional Dantrium (Dantrolene Sodium) Capsule, Unknown PS ORAL Baclofen (Baclofen) Unknown, Unknown SS ORAL Tetrahydrocannabinol (Tetrahydrocannabino l) Capsule, Unknown SS ORAL 150 MG DAILY, Other ORAL 60 MG DAILY, ORAL 8 DF DAILY, ORAL Date:07/08/02ISR Number: 3945815-9Report Type:Direct Age:51 YR Gender:Male I/FU:I Outcome Dose Disability PT Company Report #CTU 171775 Report Source Product Role Manufacturer Route Baclofen 10 Mg Watson PS Watson ORAL Crixivan Combivir Albuterol Fosamax Nephrocaps C C C C C Duration Drug Effect Decreased Drug Withdrawal Syndrome 50 MG DAILY Pharmaceutical Product ORAL Complaint Date:07/18/02ISR Number: 3955373-0Report Type:Expedited (15-DaCompany Report #20021105 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Drug Ineffective Initial or Prolonged Muscle Spasms INTRATHECAL DAILY, Required INTRATHECAL Intervention to Prevent Permanent Impairment/Damage Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Date:07/24/02ISR Number: 3953478-1Report Type:Expedited (15-DaCompany Report #2002111158GB Age:14 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Anxiety Foreign Health Professional Cyklokapron (Tranexamic Acid) Solution, Sterile PS Baclofen Mefenamic Acid SS C Duration ORAL ORAL Date:07/25/02ISR Number: 3954880-4Report Type:Expedited (15-DaCompany Report #PHBS2002IT08366 Age:72 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 37.5 MG/DAY, Initial or Prolonged ORAL PT Report Source Product Role Drug Hypersensitivity Foreign Lioresal(Baclofen) PS ORAL Generalised Erythema Health Ditropan(Oxybutynin) SS ORAL Professional 7.5 MG/DAY, Other ORAL 22-Aug-2005 Page: 137 12:15 PM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Rivotril(Clonazepam) SS ORAL Omnic (Tamsulosin Hydrochloride) SS ORAL ORAL ORAL Date:08/01/02ISR Number: 3957636-1Report Type:Expedited (15-DaCompany Report #PHBS2002JP06406 Age:20 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE PT Report Source Product Role Manufacturer Route Convulsion Disease Recurrence Foreign Health Lioresal (Baclofen) Tablet PS ORAL Drug Level Changed Hypercapnia Professional Other Phenobarbital (Phenobarbital) SS ORAL SEE IMAGE Pyrexia Respiratory Failure Depakene Benzalin Piracetam Lactic Acid (Lactic Acid) Ambroxol Hydrochloride (Ambroxol Hydrochloride) C C C C C Date:08/01/02ISR Number: 3958288-7Report Type:Expedited (15-DaCompany Report #PHNU2002DE02465 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Oedema Peripheral Foreign Health Professional Other Lioresal(Baclofen) Unknown Ribif (Interferon Beta) Role Duration Date:08/01/02ISR Number: 3958294-2Report Type:Expedited (15-DaCompany Report #PHFR2002GB02296 Age: Gender:Male I/FU:I PS SS Manufacturer Route Outcome Dose Other PT Report Source Product Role Psychotic Disorder Foreign Health Baclofen(Baclofen) Unknown PS Manufacturer Route Duration ORAL 180 MG, QD, Professional ORAL Other Date:08/06/02ISR Number: 3959397-9Report Type:Expedited (15-DaCompany Report #PHNU2002DE01956 Age:3 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Hypokalaemia Foreign Health Lioresal (Baclofen) PS Novartis ORAL Topamax (Topiramate) ... C C Duration 2.5 MG, QID, Professional ORAL;REGIMEN Other 2-8, SEE IMAGE 22-Aug-2005 Page: 138 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/14/02ISR Number: 3962179-5Report Type:Direct Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Coma Initial or Prolonged Hypotonia Required Medication Error Intervention to Muscle Spasticity Prevent Permanent Impairment/Damage INTRATHECAL 1260 MCG/D Company Report #CTU 174064 Report Source Product Role Manufacturer Baclofen For Intrathecal Use 6000 Micrograms/Ml Compound By Priorty One PS Compound By Priorty One Valium Flagyl C C Route INTRATHEAL Date:08/20/02ISR Number: 3965671-2Report Type:Expedited (15-DaCompany Report #20021138 Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Drug Withdrawal Syndrome Initial or Prolonged Medical Device INTRATHECAL MCG, DAILY, Complication INTRATHECAL Pharmaceutical Product Complaint Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Date:08/21/02ISR Number: 3966609-4Report Type:Expedited (15-DaCompany Report #PHNU2002DE02752 Age:65 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE PT Report Source Product Role Accidental Overdose Fatigue Foreign Health Lioresal (Baclofen) Tablet PS Hypertension Professional Other Date:08/21/02ISR Number: 3966610-0Report Type:Expedited (15-DaCompany Report #PHBS2002BR09516 Age:59 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Anorexia Paralysis Foreign Consumer Lioresal (Baclofen) Tablet PS Vomiting Other Manufacturer Route Duration ORAL SEE IMAGE Date:09/03/02ISR Number: 3969243-5Report Type:Expedited (15-DaCompany Report #WAES 0208CHE00033 Age:72 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 3 DAY 22-Aug-2005 Page: 139 12:15 PM PT Report Source Product Role Manufacturer Route Hypertension Stupor Health Professional Vioxx Baclofen PS SS Merck & Co., Inc ORAL ORAL Deflazacort Acetaminophen Amlodipine Besylate Aspirin Indapamide Calcium (Unspecified) And Vitamin D (Unspecified) Cozaar Hydrochlorothiazide SS C C C C ORAL ORAL ORAL ORAL ORAL C C ORAL ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report And Losartan Potassium C ORAL Date:09/03/02ISR Number: 3971521-0Report Type:Expedited (15-DaCompany Report #20021163 Age: Gender: I/FU:I Outcome Dose Other PT Report Source Product Role Health Professional Lioresal 2000 Mcg/Ml Intratheca (Baclofen Injectino) PS Manufacturer Route Route Duration Burning Sensation Feeling Cold Hypoaesthesia 580 MCG, Muscle Spasticity INTRATHECAL DAILY, INTRATHECAL Date:09/04/02ISR Number: 3969979-6Report Type:Expedited (15-DaCompany Report #320345 Age:41 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 8 DAY Initial or Prolonged 8 DAY DAILY. 8 DAY 8 DAY 8 DAY 8 PT Report Source Product Role Manufacturer Leukopenia Rivotril PS Roche Overdose Deroxat SS Renal Failure Acute Methotrexate SS Thrombocytopenia Lioresal SS Neurontin SS Topalgic SS Xanax C DAY Date:09/05/02ISR Number: 3972264-XReport Type:Expedited (15-DaCompany Report #PHBS2002IT10106 Age:52 YR Gender:Male I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Hospitalization 75 MG/DAY Initial or Prolonged ORAL Erythema Foreign Lioresal (Baclofen) PS ORAL Ditropan (Oxybutynin) SS ORAL Rivotril (Clonazepam) Drops SS ORAL Omnic (Tamsulosin Hydrochloride) C Health Professional Other 7.5 MG/DAY, ORAL 15 DROPS/DAY ORAL Date:09/05/02ISR Number: 3972269-9Report Type:Expedited (15-DaCompany Report #PHBS2002CH10098 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 75 MG/DAY, Initial or Prolonged ORAL PT Report Source Product Role Hypertensive Crisis Foreign Lioresal (Baclofen) PS ORAL Stupor Health Vioxx (Rofecoxib) SS ORAL Calcort (Deflazacort) SS ORAL Professional Manufacturer Route 25 Other MG/DAY,ORAL 15 MG/DAY, ORAL Dafalgan (Paracetamol) Norvasc Aspirine Fludex (Indapamide) Calcimagon-D3 Cosaar (Losartan 22-Aug-2005 Page: 140 12:15 PM C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Potassium) Losartan Potassium W/Hydrochlorothiazid e (Losartan Potassium) C C Date:09/05/02ISR Number: 3972270-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE02854 Age:31 YR Gender:Male I/FU:I Outcome Dose Other 25 MG, TID, PT Report Source Product Role Cholelithiasis Foreign Lioresal (Baclofen) PS Hepatic Steatosis Health Hepatitis Professional Other Propranolol C Manufacturer Route Duration ORAL ORAL Date:09/05/02ISR Number: 3972271-7Report Type:Expedited (15-DaCompany Report #PHNU2002DE02857 Age:4 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 25 MG, BID, PT Report Source Product Role Accidental Overdose Apathy Foreign Health Lioresal (Baclofen) Tablet PS Bradycardia Professional Clonic Convulsion Fatigue Medication Error Other Manufacturer Route ORAL ORAL Lioresal "Novartis" Tablet Botox (Botulinum Toxin Type A) C C Date:09/05/02ISR Number: 3972283-3Report Type:Expedited (15-DaCompany Report #PHBS2002JP06406 Age:20 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE PT Report Source Product Role Pyrexia Respiratory Failure Foreign Health Lioresal (Baclofen) Tablet PS Professional Phenobarbital Manufacturer Route ORAL Other (Phenobarbital) SS Depakene Benzalin Lactic Acid (Lactic Acid) Ambroxol Hydrochloride (Ambroxol Hydrochloride) C C ORAL SEE IMAGE C C Date:09/05/02ISR Number: 3972659-4Report Type:Expedited (15-DaCompany Report #PHBS2002JP08298 Age:73 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening PT Report Source Product Role Drug Level Increased Loss Of Consciousness Foreign Health Lioresal (Baclofen) Tablet PS 10 TO 20 Professional MG/DAY ORAL Other 22-Aug-2005 Page: 141 12:15 PM Primperan (Metoclopramide) Calcium Carbonate Tablet Pantosin (Panthethine) Nitorol Tablet C C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lasix Methycobal (Mecobalamin) Tablet Erispan (Fludiazepam) Tablet Halcion (Triazolam) C C C C Date:09/06/02ISR Number: 3971404-6Report Type:Expedited (15-DaCompany Report #320345 Age:41 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 8 DAY Initial or Prolonged 8 DAY DAILY. 8 DAY 8 DAY 8 DAY 8 PT Report Source Product Role Manufacturer Leukopenia Consumer Rivotril PS Roche Overdose Deroxat SS Renal Failure Acute Methotrexate SS Thrombocytopenia Lioresal SS Neurontin SS Topalgic (Tramadol) SS Xanax C Route DAY Date:09/09/02ISR Number: 3973743-1Report Type:Expedited (15-DaCompany Report #20021156 Age: Gender:Female I/FU:I Outcome Dose Death INTRATHECAL PT Report Source Product Role Accidental Overdose Other Lioresal? Intrathecal (Baclofen Injection) PS Duration MCG, DAILY, INTRATHECAL Date:09/09/02ISR Number: 3973758-3Report Type:Expedited (15-DaCompany Report #20021167 Age: Gender:Female I/FU:I Manufacturer Route Outcome Dose Duration Hospitalization Initial or Prolonged PT Condition Aggravated Drug Withdrawal Syndrome Incoherent MCG, DAILY, Medical Device INTRATHECAL Report Source Product Role Health Professional Lioresal? Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route INTRATHECAL Complication Muscle Spasticity Pyrexia Date:09/09/02ISR Number: 3973862-XReport Type:Expedited (15-DaCompany Report #2002054640 Age:77 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 10 MG (BID), Initial or Prolonged ORAL Other PT Report Source Product Role Arrhythmia Foreign Norvasc (Amlodipine) PS ORAL Atrial Fibrillation Health Cardiac Disorder Dizziness Professional Other Carbamazepine (Carbamazepine) SS ORAL Lioresal (Baclofen) SS ORAL Digitoxin Ferroglycine Sulfate Complex Furosemide Karvea Hct Glibenclamide C 600 MG (BID), Drug Interaction ORAL Drug Level Above 25 MG Therapeutic (DAILY), ORAL Drug Toxicity Vomiting 22-Aug-2005 Page: 142 12:15 PM C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pantoprazole Sodium Budesonide Oxitropium Bromide C C C Date:09/11/02ISR Number: 3974286-1Report Type:Expedited (15-DaCompany Report #PHNU2002DE02963 Age:77 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 25 MG, QD, Initial or Prolonged ORAL PT Report Source Product Role Atrial Flutter Foreign Lioresal (Baclofen) PS ORAL Blood Pressure Systolic Study Increased Dizziness Drug Interaction Health Professional Other Carbamazepine Azu(Carbamazepine) 200 Mg SS ORAL Norvasc(Amlodipine Besilate) SS 300 MG, BID, Drug Toxicity ORAL Nausea Vertigo 5MG, BID,ORAL Digitoxin Ferro "Sanol" (Ferroglycine Sulfate Complex) Furorese Karvezide(Irbesartan ) Maninil "Berlin-Chemie" Pantozol (Pantoprazole Sodium) Pulmicort Ventilat (Oxitropium Bromide) Oxcarbazepine Date:09/12/02ISR Number: 3975466-1Report Type:Expedited (15-DaCompany Report #PHBS2002JP08298 Age:73 YR Gender:Male I/FU:F C C C C C C C C C Manufacturer Route Outcome Dose Duration Life-Threatening PT Report Source Product Role Depressed Level Of Consciousness Foreign Health Lioresal (Baclofen) Tablet PS Drug Level Increased Professional 10 TO 20 MG/DAY, ORAL Other 22-Aug-2005 Page: 143 12:15 PM Primperan (Metoclopramide) Calcium Carbonate Pantosin (Panthethine) Nitorol Lasix Methycobal (Mecobalamin) Erispan (Fludiazepam) Halcion (Triazolam) C C C C C C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/17/02ISR Number: 3977268-9Report Type:Expedited (15-DaCompany Report #B0278371A Age:41 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Leukopenia Overdose Renal Failure Acute Foreign Paxil Tablet (Paroxetine Hydrochloride) PS ORAL Tramadol Hydrochloride (Formulation Unknown) (Tramadol Hydrochloride) SS ORAL Gabapentin (Formulation Unknown) (Gabapentin) SS ORAL Clonazepam Injection (Clonazepam) SS Baclofen Tablet (Baclofen) SS ORAL Methotrexate Tablet (Methotrexate) SS ORAL Alprazolam C 20 MG ORAL Thrombocytopenia ORAL ORAL INTRAVENOUS INTRAVENOUS ORAL ORAL Date:09/17/02ISR Number: 3977332-4Report Type:Expedited (15-DaCompany Report #PHNU2002DE03089 Age: Gender: I/FU:I Outcome Dose Other PT Report Source Product Role Drug Interaction Muscle Spasticity Foreign Health Lioresal(Baclofen) Tablet PS Professional Other Dronabinol (Dronabinol) SS Manufacturer Route Duration ORAL ORAL Date:09/18/02ISR Number: 3978402-7Report Type:Expedited (15-DaCompany Report #20021182 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL PT Dyskinesia Feeling Hot Hypoaesthesia MCG, DAILY, Injection Site Report Source Product Role Consumer Health Professional Lioresal? Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route INTRATHECAL Inflammation Injection Site Oedema Joint Stiffness Muscular Weakness Neck Pain Paraesthesia Pyrexia Date:09/18/02ISR Number: 3978403-9Report Type:Expedited (15-DaCompany Report #20021185 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged MCG, DAILY, INTRATHECAL 22-Aug-2005 Page: 144 12:15 PM PT Report Source Product Role Meningitis Staphylococcal Health Professional Lioresal? Intrathecal (Baclofen Injection) PS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/18/02ISR Number: 3979986-5Report Type:Expedited (15-DaCompany Report #PHBS2002BE10260 Age:1 YR Gender:Female I/FU:I Outcome Dose Other ORAL PT Report Source Product Role Hepatotoxicity Foreign Baclofen (Baclofen) PS Manufacturer Route Duration ORAL Literature Health Professional Other Date:09/19/02ISR Number: 3977960-6Report Type:Expedited (15-DaCompany Report #PHBS2002IT10106 Age:52 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 75 MG/DAY, Initial or Prolonged ORAL PT Report Source Product Role Erythema Foreign Lioresal (Baclofen) PS ORAL Ditropan (Oxybutynin) SS ORAL Rivotril (Clonazepam) Drops SS ORAL Omnic (Tamsulosin Hydrochloride) C Manufacturer Route Health Professional Other 7.5 MG/DAY, ORAL 15 DROPS/DAY, ORAL Date:09/19/02ISR Number: 3977967-9Report Type:Expedited (15-DaCompany Report #PHBS2002IT08366 Age:72 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 37.5 MG/DAY, Initial or Prolonged ORAL PT Report Source Product Role Generalised Erythema Foreign Lioresal (Baclofen) PS Health Manufacturer Route ORAL Professional Other Ditropan (Oxybutynin) SS Rivotril (Clonazepam) SS ORAL Omnic (Tamsulosin Hydrochloride) SS ORAL 7.5 MG/DAY ORAL 0.4 MG/DAY,ORAL Date:09/19/02ISR Number: 3978164-3Report Type:Expedited (15-DaCompany Report #PHBS2002JP08298 Age:73 YR Gender:Male I/FU:F Outcome Dose Duration Life-Threatening PT Report Source Product Role Drug Level Increased Loss Of Consciousness Foreign Health Lioresal(Baclofen) Tablet PS 10 TO 20 Professional MG/DAY, ORAL Other 22-Aug-2005 Page: 145 12:15 PM Primperan (Metoclopramide) Calcium Carbonate Pantosin (Pantethine) Nitrol Lasix Methycobal (Mecobalamin) Eripsan (Fludiazepam) Halcion (Triazolam) C C C C C C C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/19/02ISR Number: 3978322-8Report Type:Expedited (15-DaCompany Report #20021187 Age: Gender:Male I/FU:I Outcome PT Dose Duration Life-Threatening Unevaluable Event Hospitalization Initial or Prolonged INTRATHECAL MCG, DAILY, Report Source Product Role Health Professional Lioresal? Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route INTRATHECAL Date:09/25/02ISR Number: 3981657-6Report Type:Expedited (15-DaCompany Report #PHNU2002DE02857 Age:4 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 25 MG, BID, PT Report Source Product Role Accidental Overdose Apathy Foreign Health Lioresal (Baclofen) Tablet PS Bradycardia Professional Clonic Convulsion Coma Dyskinesia Fatigue Grand Mal Convulsion Hypotonia Medication Error Miosis Pupillary Light Reflex Tests Abnormal Somnolence Tremor Other ORAL ORAL Lioresal "Novartis" Tablet Botox (Botulinum Toxin Type A) C C Date:09/25/02ISR Number: 3981956-8Report Type:Expedited (15-DaCompany Report #PHHO2001FR08069 Age:80 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 300 MG, BID, PT Report Source Product Role Incontinence Somnolence Foreign Study Trileptal (Trileptal T22413+) PS Manufacturer Route ORAL Health ORAL Professional Other Zoloft (Sertraline Hydrochloride) Lioresal (Baclofen) SS SS Mopral (Omeprazole) C 30 MG, TID, Date:10/02/02ISR Number: 3984603-4Report Type:Expedited (15-DaCompany Report #PHHO2001FR08069 Age:80 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 300 PT Report Source Product Role Incontinence Somnolence Foreign Study Health Trileptal (Trileptal T22413+) Trileptal(Trileptal) PS MG, BID, Professional ORAL Other Zoloft (Sertraline Hydrochloride) Lioresal (Baclofen) Unknown SS SS 30 MG, TID Mopral (Omeprazole) 22-Aug-2005 Page: 146 12:15 PM C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/02/02ISR Number: 3986831-0Report Type:Expedited (15-DaCompany Report #PHBS2002JP06406 Age:40 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 120 MG/DAY, ORAL; PT Report Source Product Role Manufacturer Route Drug Level Increased Epilepsy Foreign Health Lioresal(Baclofen)Ta blet PS ORAL Hypercapnia Professional Pyrexia Other Phenobarbital (Phenobarbital ) SS ORAL SEE IMAGE Respiratory Depression Respiratory Failure 200 MG/D, ORAL; SEE IMAGE Depakene Benzalin Lactic Acid(Lacticf Acid) Ambroxol Hydrochloride(Ambrox ol Hydrochloride) Piracetam C C C C C Date:10/07/02ISR Number: 3989632-2Report Type:Expedited (15-DaCompany Report #PHBS2002AR11469 Age:52 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 10 MG, TID, Initial or Prolonged ORAL PT Report Source Product Role Activated Partial Foreign Lioresal (Baclofen) PS Thromboplastin Time Health Abnormal Agitation Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Blood Alkaline Professional Other Heparin (Heparin) Acetylsalicylic Acid Omeprazole (Omeprazole) Alplax (Alprazolam) Trapax Tablet Folic Acid Calcium Carbonate C C C C C C C Manufacturer Route ORAL Phosphatase Increased Blood Bilirubin Increased Confusional State Prothrombin Time Shortened Erythropoietin (Erythropoietni) C Date:10/08/02ISR Number: 3989955-7Report Type:Expedited (15-DaCompany Report #02P-163-0201357-00 Age:44 YR Gender:Male I/FU:I Outcome Dose Duration Death Life-Threatening Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 147 12:15 PM PT Report Source Product Cardiac Arrest Depressed Level Of Consciousness Grand Mal Convulsion Intentional Misuse Literature Health Professional Dipotassium Clorazepate (Tranxene) (Clorazepate Dipotassium) Amitriptyline Dextropropoxyphene Oxybutynin Cyclobenzaprine Baclofen Cisapride Omeprazole Diosmin Glycopyrronium Bromide Role PS SS SS SS SS SS SS SS SS SS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/08/02ISR Number: 3990003-3Report Type:Expedited (15-DaCompany Report #D0039382A Age:30 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 500 MG SINGLE PT Report Source Product Role Manufacturer Route Accidental Exposure Blood Pressure Systolic Foreign Health Lamictal Tablet (Lamotrigine) PS ORAL Decreased Professional Oxcarbazepine Tablet (Oxcarbazepine) SS ORAL Baclofen Tablet (Baclofen) SS ORAL Levetiracetam Tablet (Levetiracetam) SS ORAL DOSE ORAL Therapeutic Agent Toxicity 2400 MG SINGLE DOSE ORAL 10 MG SINGLE DOSE ORAL 2000 MG SINGLE DOSE ORAL Date:10/09/02ISR Number: 3991016-8Report Type:Expedited (15-DaCompany Report #PHFR2002GB03125 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Photosensitivity Reaction Foreign Health Diclofenac (Diclofenac) PS Duration UNK, UNK, Professional UNKNOWN Other Lioresal(Baclofen) Unknown Librium "Hoffman" (Chlordiazeoxide Hydrochloride) SS C Manufacturer Route Dothiepin (Dosulepin) C Date:10/15/02ISR Number: 3993753-8Report Type:Expedited (15-DaCompany Report #NSADSS2002032587 Age:57 YR Gender:Female I/FU:F Outcome Dose Death PT Report Source Product Role Manufacturer Route Blood Glucose Increased Blood Ph Decreased Completed Suicide Intentional Misuse Literature Health Professional Tylenol With Codeine (Unspecified) (Acetaminophen/Codei ne) PS ORAL Baclofen (Baclofen) SS ORAL Duration ORAL Renal Impairment ORAL Respiratory Arrest Date:10/16/02ISR Number: 3993679-XReport Type:Expedited (15-DaCompany Report #20021187 Age: Gender:Male I/FU:F Outcome Dose Duration Life-Threatening Hospitalization INTRATHECAL DAILY, Initial or Prolonged INTRATHECAL PT Report Source Product Role Drug Level Below Therapeutic Health Professional Lioresal Intrathecal (Baclofen Injection) PS Medical Device Complication 22-Aug-2005 Page: 148 12:15 PM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/17/02ISR Number: 3995652-4Report Type:Expedited (15-DaCompany Report #PHBS2002BR11953 Age:34 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 40 TABLETS/D, PT Report Source Product Role Coma Intentional Misuse Foreign Health Lioresal (Baclofen) Tablet PS Miosis Professional Respiratory Depression Suicide Attempt Other Phenobarbital (Phenobarbital) SS Manufacturer Route ORAL ORAL Date:10/17/02ISR Number: 3997059-2Report Type:Expedited (15-DaCompany Report #GRP02000157 Age:35 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged ORAL PT Report Source Product Role Manufacturer Route Anaemia Arthritis Beta Haemolytic Foreign Health Professional Dantamacrin(Dantrole ne Sodium) Capsule, Unknownmg PS ORAL Streptococcal Infection Blister Other Timonil(Carbamazepin e) SS ORAL Candida Pneumonia Epidermolysis Lioresal "Novartis" (Baclofen) SS ORAL Erythema Pancytopenia Oxybutynin(Oxybutyni n) SS ORAL Peritonsillar Abscess Photosensitivity Reaction Tranxilium(Clorazepa te Dipotassium) SS ORAL Acimethin(Methionine ) SS ORAL Fragmin(Heparin-Frac tion, Sodium Salt) SS ORAL Nystatin(Nystatin) SS ORAL ORAL ORAL ORAL ORAL ORAL ORAL ORAL Date:10/24/02ISR Number: 3995588-9Report Type:Expedited (15-DaCompany Report #D0039382A Age:30 YR Gender:Male I/FU:F Outcome PT Dose Duration Hospitalization Blood Pressure Systolic 500MG Single Initial or Prolonged Decreased dose 1 DAY Drug Toxicity 2400MG Single dose 1 Report Source Product Role Manufacturer Route Health Lamictal PS Glaxo Wellcome ORAL Trileptal SS ORAL Lioresal SS ORAL Keppra SS ORAL Professional DAY 10MG Single dose 1 DAY 2000MG Single dose 1 DAY Date:10/25/02ISR Number: 4000730-XReport Type:Expedited (15-DaCompany Report #20021200 Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Catheter Related Initial or Prolonged Complication INTRATHECAL MCG, DAILY, Discomfort INTRATHECAL Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Date:10/25/02ISR Number: 4000769-4Report Type:Expedited (15-DaCompany Report #EMADSS2002006188 Age:38 YR Gender:Male I/FU:I Outcome Other 22-Aug-2005 Page: 149 PT Convulsion Drug Interaction 12:15 PM Report Source Foreign Health Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Professional Product Dose Role Manufacturer Route Manufacturer Route Duration Topalgic Tramadol Hydrochloride) Deroxat (Paroxetine Hydrochloride) Lioresal (Baclofen) Neurontin (Gabapentin) PS SS SS C Date:10/28/02ISR Number: 4001488-0Report Type:Expedited (15-DaCompany Report #20021202 Age: Gender:Male I/FU:I Outcome PT Dose Duration Life-Threatening Discomfort Hospitalization Gastric Dilatation INTRATHECAL MCG, DAILY, Initial or Prolonged Gastric Volvulus INTRATHECAL Intestinal Dilatation Post Procedural Complication Upper Gastrointestinal Haemorrhage Urinary Retention Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Date:10/29/02ISR Number: 3998819-4Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12081485 Age:63 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Daily dose: PT Haematemesis Ulcer Report Source Product Role Manufacturer Route Warfarin Sodium PS Bristol-Myers Squibb Company ORAL as per INR Acetylsalicylic Acid Diclofenac Baclofen SS SS SS ORAL ORAL ORAL Folic Acid Co-Amilofruse C C ORAL ORAL Simvastatin Epilim Uniphyllin Co-Codamol C C C C ORAL ORAL ORAL ORAL Daily dosage: 5/40 Date:10/30/02ISR Number: 4003291-4Report Type:Expedited (15-DaCompany Report #PHBS2002AU05729 Age:41 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Alanine Aminotransferase Increased Foreign Health Lioresal (Baclofen) Unknown PS Aspartate Professional Aminotransferase Increased Gamma-Glutamyltransferase Increased Other 10 MG, TID, ORAL 22-Aug-2005 Page: 150 Manufacturer Route Duration 12:15 PM Mormison Stilnox (Zolpidem) Valium Endone (Oxycodone Hydrochloride) Pethidine (Pethidine) C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Zomig (Zolmitriptan) Maxolon Prochlorperazine Maleate (Prochlorperazine Maleate) Brevinor (Noresthisterone) Diclocil (Dicloxacillin Sodium Monohydrate) C C C C C Date:10/31/02ISR Number: 4004234-XReport Type:Expedited (15-DaCompany Report #PHFR2002GB03125 Age:49 YR Gender:Female I/FU:F Outcome Dose Disability Other 75 MG, TID; PT Report Source Product Role Manufacturer Route Photosensitivity Reaction Foreign Health Diclofenac(Diclofena c) Unknown PS ORAL Lioresal(Baclofen) Unknown SS ORAL Duration Professional ORAL Other 10 MG/DAY, ORAL Librium "Hoffman" (Chlordiazepoxide Hydrochloride) Dothiepin (Dosulepin) C C Date:11/04/02ISR Number: 4006150-6Report Type:Expedited (15-DaCompany Report #PHFR2002GB03463 Age:63 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 75 MG/DAY, ORAL PT Report Source Product Role Gastrointestinal Ulcer Haematemesis Foreign Health Diclofenac (Diclofenac) PS Haemoglobin Decreased Professional Manufacturer Route ORAL International Normalised Other Baclofen (Baclofen) SS ORAL Warfarin (Warfarin) SS ORAL Aspirine (Acetylsalicylic Acid) SS ORAL 10 MG/DAY, Ratio Increased ORAL ORAL 75 MG/DAY, ORAL Folic Acid Co-Amilofruse Simvastatin Epilim Uniphyllin "Napp" Co-Codamol (Paracetamol) C C C C C C Date:11/05/02ISR Number: 4006957-5Report Type:Expedited (15-DaCompany Report #PHNU2002DE02752 Age:65 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE 22-Aug-2005 Page: 151 12:15 PM PT Report Source Product Role Accidental Overdose Fatigue Foreign Health Lioresal (Baclofen) Tablet PS Hypertension Professional Other Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/06/02ISR Number: 4008525-8Report Type:Expedited (15-DaCompany Report #PHBS2002JP12793 Age:4 YR Gender:Female I/FU:I Outcome Dose Other 10 MG/DAY, PT Report Source Product Role Fanconi Syndrome Acquired Foreign Lioresal (Baclofen) PS Renal Tubular Disorder Health Manufacturer Route Duration ORAL ORAL Professional Other Date:11/06/02ISR Number: 4008526-XReport Type:Expedited (15-DaCompany Report #PHRM2002FR02640 Age:19 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE SUBCUTANEOUS PT Report Source Product Role Neutropenia Foreign Health Lioresal (Baclofen) Tablet PS Professional Other Fraxiparine (Heparin-Fraction, Calcium Salt) Solution SS Manufacturer Route ORAL 1 DF, QD, SUBCUTANEOUS Date:11/08/02ISR Number: 4012252-0Report Type:Expedited (15-DaCompany Report #PHNU2002DE02854 Age:31 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Cholangitis Cholelithiasis Foreign Health Lioresal (Baclofen) Tablet PS Hepatic Steatosis Professional Propra-Ratiopharm C Manufacturer Route Duration 25 MG, TID, ORAL; 25 MG, Other TID, ORAL ORAL Date:11/11/02ISR Number: 4007050-8Report Type:Expedited (15-DaCompany Report #US-BRISTOL-MYERS SQUIBB COMPANY-12081485 Age:63 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged Daily dose: PT Report Source Product Role Manufacturer Route Haematemesis Haemoglobin Decreased Health Professional Warfarin Sodium PS Bristol-Myers Squibb Company ORAL International Normalised as per INR Ratio Increased Ulcer Acetylsalicylic Acid Diclofenac Baclofen Folic Acid Co-Amilofruse SS SS SS C C ORAL ORAL ORAL ORAL ORAL Simvastatin Epilim Uniphyllin Co-Codamol C C C C ORAL ORAL ORAL ORAL Daily dosage: 5/40 Date:11/13/02ISR Number: 4012308-2Report Type:Expedited (15-DaCompany Report #200214441FR Age:36 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SUBCUTANEOUS 10 MG TID PO 22-Aug-2005 Page: 152 PT Report Source Product Role Neutropenia Foreign Other Heparin-Fraction, Sodium Salt (Lovenox) PS Baclofen (Lioresal) SS 40 MG QD SC 13 DAY 12:15 PM 5 Manufacturer Route WK ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/15/02ISR Number: 4013153-4Report Type:Expedited (15-DaCompany Report #PHNU2002DE03679 Age:45 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Condition Aggravated Pyrexia Foreign Health Lioresal (Baclofen) Tablet PS Metoclopramide Tavor Heparin C C C Manufacturer Route Duration ORAL 30MG/DAY, Professional ORAL Other Date:11/18/02ISR Number: 4013548-9Report Type:Expedited (15-DaCompany Report #2002003941 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL Other PT Report Source Product Role Drug Withdrawal Syndrome Grand Mal Convulsion Health Professional Zoloft (Sertraline Hydrochloride) PS White Blood Cell Count Increased Baclofen (Baclofen) Klonopin (Clonazepam) SS Atenolol Fentanyl Morphine Simvastatin C C C C Manufacturer Route ORAL SS 3 MG (TID) Date:11/18/02ISR Number: 4013896-2Report Type:Expedited (15-DaCompany Report #PHBS2002TW13256 Age:61 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 5 MG, TID Initial or Prolonged PT Report Source Product Role Asthenia Foreign Baclofen(Baclofen) PS Drug Toxicity Haemodialysis Hyporeflexia Hypotonia Nausea Literature Health Professional Other Manufacturer Route Speech Disorder Toxic Induced Encephalopathy Vision Blurred Vomiting Date:11/20/02ISR Number: 4016764-5Report Type:Expedited (15-DaCompany Report #PHBS2002JP12793 Age:4 YR Gender:Female I/FU:F Outcome Dose Disability 10 MG/DAY, PT Report Source Product Role Manufacturer Route Fanconi Syndrome Acquired Foreign Lioresal (Baclofen) PS ORAL Renal Tubular Disorder Health Valproic Acid (Valproic Acid) SS ORAL Duration ORAL Professional Other 450 MG/DAY, ORAL Excergan (Zonisamide) Rivotril Phenobal Dantrium (Dantrolene Sodium) Mucodyne Meptin (Procaterol Hydrochloride) 22-Aug-2005 Page: 153 12:15 PM C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Clarith (Clarithromycin) C Date:11/20/02ISR Number: 4016785-2Report Type:Expedited (15-DaCompany Report #PHBS2002BR13602 Age:22 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 20 TABLETS, PT Report Source Product Role Manufacturer Route Agitation Hypotension Foreign Health Lioresal (Baclofen) Tablet PS ORAL Intentional Misuse Professional Mydriasis Other Amitripyline (Amitriptyline) Tablet SS ORAL Oxybutynin (Oxybutynin) Tablet SS ORAL Diazepam (Diazepam) Tablet SS ORAL ONCE/SINGLE, ORAL Suicide Attempt 20 DF, ONCE/SINGLE, ORAL 10 TABLETS, ONCE/SINGLE, ORAL 10 TABLETS, ONCE/SINGLE, ORAL Date:11/22/02ISR Number: 4016036-9Report Type:Expedited (15-DaCompany Report #EMADSS2002006188 Age:38 YR Gender:Male I/FU:F Outcome Dose PT Duration Report Source Product Role Manufacturer Route Hospitalization Initial or Prolonged Other Convulsion Drug Interaction Foreign Health Professional Topalgic (Unspecified) (Tramadol Hydrochloride) PS Deroxat (Paroxetine Hyrochloride) SS Lioresal (Baclofen) SS Neurontin (Gabapentin) C 300 MG, DAILY 20 MG, DAILY 30 MG, DAILY Date:11/26/02ISR Number: 4017585-XReport Type:Expedited (15-DaCompany Report #PHBS2002CL04226 Age:57 YR Gender:Male I/FU:F Outcome Dose Other SEE IMAGE PT Report Source Product Role Pulmonary Fibrosis Sarcoidosis Foreign Consumer Lioresal(Baclofen)Ta blet PS Enalapril (Enalapril) Diazepam C C 1095 DAY Date:12/02/02ISR Number: 4020521-3Report Type:Expedited (15-DaCompany Report #20021236 Age: Gender:Male I/FU:I Outcome Death 22-Aug-2005 Page: 154 Manufacturer Route Duration PT Brain Death Coma Hypotonia Pupil Fixed 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Ventricular Fibrillation Dose INTRATHECAL Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route Duration UNK MCG, DAILY, INTRATHECAL Date:12/02/02ISR Number: 4020792-3Report Type:Expedited (15-DaCompany Report #20021235 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Clonic Convulsion Initial or Prolonged Muscle Spasticity INTRATHECAL 536 MCG, Pneumonia DAILY, Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Tizanidine Lorazepam Clonazepam C C C INTRATHECAL Date:12/02/02ISR Number: 4020794-7Report Type:Expedited (15-DaCompany Report #20021232 Age: Gender:Female I/FU:I Outcome Dose Other INTRATHECAL PT Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Duration Csf Bacteria Identified Diphtheria MCG, DAILY, Drug Withdrawal Syndrome INTRATHECAL Meningitis Date:12/03/02ISR Number: 4022059-6Report Type:Expedited (15-DaCompany Report #PHBS2002BR13602 Age:22 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 20 TABLETS, PT Report Source Product Role Agitation Heart Rate Increased Foreign Health Lioresal (Baclofen) Tablet PS ORAL Hypotension Professional Intentional Misuse Other Amitriptyline (Amitriptyline) Tablet SS ORAL Oxybutynin (Oxybutynin) Tablet SS ORAL Diazepam (Diazepam) Tablet SS ORAL Manufacturer Route ONCE/SINGLE, ORAL Mydriasis Suicide Attempt 20 DF, ONCE/SINGLE, ORAL 10 TABLETS, ONCE/SINGLE, ORAL 10 TABLETS, ONCE/SINGLE, ORAL Date:12/09/02ISR Number: 4020800-XReport Type:Direct Age:56 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization 22-Aug-2005 Page: 155 12:15 PM Company Report #CTU 182317 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged Required Intervention to Prevent Permanent Dose Duration Impairment/Damage PT Report Source Asthenia Difficulty In Walking Product Role Baclofen 2000.0 Ug/Ml PS Manufacturer Route Manufacturer Route Manufacturer Route INTRADISCAL (INTRASPINAL) Dyspnoea 19.8 UG/HR Medication Error INTRADISCAL Pharmaceutical Product Complaint Date:12/09/02ISR Number: 4023061-0Report Type:Expedited (15-DaCompany Report #02P-163-0205269-00 Age:37 YR Gender:Unknown I/FU:I Outcome Dose Death PT Report Source Product Role Completed Suicide Literature Health Professional Hydrocodone/Acetamin ophen (Vicodin) (Hydrocodone/Acetami nophen) Venlafaxine Baclofen PS SS SS Duration Date:12/09/02ISR Number: 4023117-2Report Type:Expedited (15-DaCompany Report #PHNU2002DE03679 Age:45 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Condition Aggravated Pyrexia Foreign Health Lioresal (Baclofen) Tablet PS Professional Other Metoclopramide (Metoclopramide) Tavor Heparin (Heparin) C C C Duration SEE IMAGE Date:12/10/02ISR Number: 4024891-1Report Type:Expedited (15-DaCompany Report #PHNU2002DE03089 Age: Gender:Unknown I/FU:F ORAL Outcome Dose Other PT Report Source Product Role Drug Interaction Muscle Spasticity Foreign Health Lioresal (Baclofen) Tablet PS Professional Other Dronabinol (Dronabinol) SS Mydocalm "Strathmann" (Tolperisone Hydrochloride) Sirdalud Benzodiazepines C C C Manufacturer Route Duration ORAL ORAL CHANGING DOSAGE Date:12/11/02ISR Number: 4025240-5Report Type:Expedited (15-DaCompany Report #PHRM2002FR02963 Age:36 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 10 MG, TID, PT Report Source Product Role Agranulocytosis Pyrexia Foreign Health Lioresal (Baclofen) Tablet PS White Blood Cell Count Professional Decreased Other INTRAGASTRIC 22-Aug-2005 Page: 156 12:15 PM Lovenox (Heparin-Fraction, Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sodium Salt) Solution For Injection SUBCUTANEOUS SS 40 MG, QD; SUBCUTANEOUS Date:12/16/02ISR Number: 4027524-3Report Type:Expedited (15-DaCompany Report #PHFR2002GB04053 Age:46 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 20 MG/DAY, PT Report Source Product Role Haematemesis Haemoglobin Decreased Foreign Health Baclofen(Baclofen) Unknown PS Oesophagitis Professional Diazepam Lactulose C C Manufacturer Route ORAL ORAL Other Date:12/16/02ISR Number: 4027526-7Report Type:Expedited (15-DaCompany Report #PHFR2002GB04054 Age:82 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 5MG/DAY , PT Report Source Product Role Haematemesis Haemoglobin Decreased Foreign Health Baclofen (Baclofen) Unknown PS Lanzoprazole(Lanzopr azole) Amoxicillin C C Manufacturer Route ORAL Professional ORAL Other Date:12/16/02ISR Number: 4032190-7Report Type:Expedited (15-DaCompany Report #USA-2002-008204 Age:42 YR Gender:Female I/FU:I Outcome Dose Duration Death Hospitalization - PT Report Source Product Optic Neuritis Pneumonia Study Health Betaseron (Interferon Beta - Role Manufacturer Route Initial or Prolonged Quadriplegia SUBCUTANEOUS SEE IMAGE Disability INTRATHECAL INTRATHECAL Professional 1b) Injection PS Baclofen (Baclofen) SS Albuterol Tequin (Gatifloxacin) Neurontin (Gabapentin) Multivitamins (Ergocalciferol, Retinol, Panthenol) Mandelamine "Park-Davis" (Methenamine Mandelate) Diovan "Novartis" (Valsartan) Elavil C C C C C C C Date:12/18/02ISR Number: 4027955-1Report Type:Expedited (15-DaCompany Report #02-12-1104 Age:82 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 5MG QD ORAL 22-Aug-2005 Page: 157 12:15 PM PT Report Source Product Role Haematemesis Foreign Other Baclofen - Ipi Tablets PS Lansoprazole Amoxicillin C C Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/20/02ISR Number: 4029155-8Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Required 5MG ONCE ORAL Intervention to Prevent Permanent Impairment/Damage PT Company Report #CTU 183156 Report Source Product Role Manufacturer Route Coma Heart Rate Decreased Baclofen 10mg Upsher-Smith PS Upsher-Smith ORAL Hypotension Compazine Vicodin Glipizide Xl Isosorbide Er Lovastatin Methylphenidiate C C C C C C Manufacturer Route Date:12/30/02ISR Number: 4036646-2Report Type:Expedited (15-DaCompany Report #PHNU2002DE04194 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 12.5 MG, BID, PT Report Source Product Role Asthenia Depressed Level Of Foreign Health Lioresal (Baclofen) Tablet PS Consciousness Professional Drug Level Above Other ORAL; 10 MG, BID, ORAL; 5 Therapeutic MG, BID, ORAL Dysarthria Fatigue Muscular Weakness Narcolepsy Overdose Reflux Oesophagitis Vomiting L-Thyroxin Henning Berlin Dreisavit Nexium Mups (Esomeprazole) Lactulose Mcp Hexal Baldrian-Dispert (Valeriana Officinalis Root) C C C C C C Date:12/31/02ISR Number: 4040235-3Report Type:Expedited (15-DaCompany Report #SAG/INT-10/0/13/10/1 Age:58 YR Gender:Male I/FU:F ORAL Outcome Dose Duration Hospitalization Initial or Prolonged INTRAVENOUS PT Report Source Product Role Aphasia Disease Recurrence Epilepsy Grand Mal Convulsion Multiple Sclerosis Foreign Health Professional Other Sandoglobulin Or Placebo (Placebo Placebo) (Sandoglobulin Or Placebo) PS QMO, Relapse INTRAVENOUS Postictal State Pyrexia 22-Aug-2005 Page: 158 12:15 PM Baclofen (Baclofen) Capsule Ds 103-282 (Tizanidine Hydrochloride) Capsule Neuromet (Oxiracetam) Orfiril (Valproate Sodium) SS SS C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/06/03ISR Number: 4036977-6Report Type:Direct Age:51 YR Gender:Female I/FU:I Outcome Dose Other PT Company Report #CTU 183902 Report Source Product Role Manufacturer Route Baclofen 10 Mg Rosemont/Geneva PS Rosemont/Geneva Product Role Manufacturer Route Baclofen 20 Mg Watson PS Watson ORAL Oxycontin Oxycodone Fibercon Sennacot Colace Benadryl C C C C C C Manufacturer Route Duration Drug Ineffective Pharmaceutical Product 10 MG 3 X A Complaint DAY Date:01/08/03ISR Number: 4038506-XReport Type:Direct Age:50 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 20 MG TID Initial or Prolonged ORAL Disability PT Company Report #CTU 184078 Report Source Drug Withdrawal Syndrome Hip Fracture Road Traffic Accident Spinal Compression Fracture Syncope Tibia Fracture Date:01/10/03ISR Number: 4040943-4Report Type:Expedited (15-DaCompany Report #20010894 Age: Gender:Male I/FU:F Outcome Dose Death INTRATHECAL PT Report Source Product Role Health Professional Lioresa (Baclofen Injection) PS See B5 C Duration Blood Creatine Phosphokinase Increased 967 MCG DAILY Body Temperature INTRATHECAL Increased INTRATHECAL Csf Glucose Abnormal Csf Protein Abnormal Hypoaesthesia Lung Disorder Post Procedural Complication Date:01/13/03ISR Number: 4041205-1Report Type:Direct Age:51 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 10MG 3X DAY PT Product Role Manufacturer Difficulty In Walking Muscle Spasticity Baclofen 10mg Rosemont PS Rosemont Pharmaceutical Product Complaint Baclofen 10mg Geneva SS Geneva Product Role Manufacturer Route Baclofen - Watson 10mg Tabs PS Watson ORAL Date:01/16/03ISR Number: 4042953-XReport Type:Direct Age:49 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1T PO TID PT Dyspnoea Pharmaceutical Product Complaint Pharyngeal Oedema 22-Aug-2005 Page: 159 12:15 PM Company Report #CTU 184305 Report Source Route Company Report #CTU 184755 Report Source FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/03ISR Number: 4045117-9Report Type:Expedited (15-DaCompany Report #B0286936A Age:40 YR Gender:Unknown I/FU:I Outcome Dose Death PT Report Source Product Role Death Literature Health Aspirin (Formulation Unknown) (Aspirin) PS ORAL Professional Paracetamol (Formulation Unknown) (Acetaminophen) SS ORAL Baclofen (Formulation Unknown SS ORAL Manufacturer Route Duration ORAL ORAL ORAL Date:01/23/03ISR Number: 4046877-3Report Type:Expedited (15-DaCompany Report #PHNU2003DE00472 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Delusional Disorder, Persecutory Type Hallucination Foreign Health Professional Lioresal (Baclofen) Norvasc Sandocal "Novartis" (Sodium) Stilnox (Zolpidem) Marcumar (Phenprocoumon) PS C Manufacturer Route Route Duration Date:02/03/03ISR Number: 4050591-8Report Type:Direct Age:47 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization SUBCUTANEOUS 100 MG Initial or Prolonged 12 Disability SUBCUTANEOUS Required PT Anal Sphincter Atony Back Pain EVERY Cellulitis C Company Report #CTU 185805 Report Source Product Role Manufacturer Enoxaparin-Lovenox100 Mg Aventis PS Aventis Deep Vein Thrombosis Hyporeflexia C C Baclofen-Intrathecal Intervention to Implant Site Infection INTRATHECAL CONTINUOUS Prevent Permanent Implant Site Reaction INTRATHECAL Impairment/Damage Operative Haemorrhage Paraplegia Subdural Haematoma Drug In Pump Geigy SS Warfarin C Geigy Date:02/05/03ISR Number: 4051268-5Report Type:Expedited (15-DaCompany Report #WAES 0208CHE00033 Age:72 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 3 DAY 22-Aug-2005 Page: 160 12:15 PM PT Hypertension Stupor Report Source Product Role Manufacturer Route Vioxx Baclofen PS SS Merck & Co., Inc ORAL ORAL Deflazacort Acetaminophen Amlodipine Besylate Aspirin Indapamide Calcium (Unspecified) And Vitamin D (Unspecified) Cozaar Hydrochlorothiazide And Losartan Potassium SS C C C C ORAL ORAL ORAL ORAL ORAL C C ORAL ORAL C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/05/03ISR Number: 4053353-0Report Type:Expedited (15-DaCompany Report #DCC03003 BAC Age:51 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 10 MG ORAL Initial or Prolonged PT Report Source Product Role Manufacturer Route Difficulty In Walking Consumer Baclofen PS Usp ORAL Muscle Spasticity Other Estrace Lasix Xanax Effexor Detrol Loricet C C C C C C Manufacturer Route Manufacturer Route Date:02/14/03ISR Number: 4056899-4Report Type:Direct Age: Gender:Male I/FU:I Outcome PT Dose Duration Required Areflexia Intervention to Coma Prevent Permanent Hypotonia INTRATHECAL 400-420 MCG Impairment/Damage Hypoventilation DAILY Irritability INTRATHECA Company Report #CTU 186719 Report Source Product Role Lioresal Intrathecal(Baclofen Injection) PS Date:02/24/03ISR Number: 4065260-8Report Type:Expedited (15-DaCompany Report #HQWYE522020FEB03 Age: Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Role Adverse Drug Reaction Consumer Infumorph (Morphine Sulfate, Injection) PS Baclofen (Baclofen) SS Duration INTRASPINAL Date:02/27/03ISR Number: 4067358-7Report Type:Expedited (15-DaCompany Report #PHNU2003DE00538 Age:31 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Abortion Complications Of Maternal Foreign Health Lioresal(Baclofen) Tablet, 10mg PS Exposure To Therapeutic Drugs Maternal Drugs Affecting Foetus Professional Other Manufacturer Route Duration ORAL SEE IMAGE Date:03/04/03ISR Number: 4070019-1Report Type:Expedited (15-DaCompany Report #20031317 Age:58 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL PT Report Source Product Role Coma Drug Effect Decreased Hyperpyrexia Consumer Health Professional Lioresal Intrathecal(Baclofen Injection) PS DAILY, Medical Device INTRATHECAL Complication Overdose 22-Aug-2005 Page: 161 12:15 PM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/07/03ISR Number: 4071715-2Report Type:Expedited (15-DaCompany Report #03-02-0220 Age:17 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Areflexia INTRATHECAL 75-350UG/D Initial or Prolonged Asthenia INTRATHECAL 11 MON Other Catheter Related Complication Clonic Convulsion Deep Vein Thrombosis Hypotonia Migration Of Implant Muscle Spasticity Post Procedural Complication Report Source Product Role Literature Baclofen PS Manufacturer Route Manufacturer Route Health Professional Date:03/07/03ISR Number: 4072935-3Report Type:Expedited (15-DaCompany Report #PHNU2002DE04194 Age: Gender:Male I/FU:F Outcome Dose Duration Life-Threatening Hospitalization 10 MG, BID, Initial or Prolonged ORAL; 5 MG, PT Report Source Product Role Asthenia Coma Foreign Health Lioresal(Baclofen) Tablet PS Convulsion Professional Depressed Level Of Other BID, ORAL Consciousness Drug Level Above Therapeutic Dysarthria Fall Fatigue Haemodialysis Liver Disorder Muscular Weakness Narcolepsy Overdose Reflux Oesophagitis Renal Failure L-Thyroxin "Henning Berlin" Dreisavit Nexium Mups (Esomeprazole) Lactulose Mcp "Hexal" Baldrian-Dispert (Valeriana Officinalis Root) C C C C C C ORAL Date:03/13/03ISR Number: 4076154-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE00472 Age: Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Delusional Disorder, Persecutory Type Foreign Health Lioresal(Baclofen) Unknown PS Hallucination Professional Other Norvasc Sandocal "Novartis" Sodium Stilnox (Zolpidem) Marcumar(Phenprocoum on) ORAL Date:03/17/03ISR Number: 4077770-8Report Type:Expedited (15-DaCompany Report #2003009487 Age: Gender:Female I/FU:I Outcome Other 22-Aug-2005 Page: 162 Manufacturer Route Duration PT Alopecia Arrhythmia Blood Pressure Increased Cardiac Failure 12:15 PM C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Dizziness Drug Hypersensitivity Heart Rate Increased Report Source Product Role Hypotension Memory Impairment Foreign Consumer Neurontin (Gabapentin) PS Manufacturer Route Duration ORAL 50 MG, ORAL Myocardial Infarction Pain Pulmonary Hypertension Restlessness Somnolence Thinking Abnormal Tricuspid Valve Disease Weight Decreased Weight Increased Nitrostat (Glyceryl Trinitrate) Lidocaine Baclofen K-Lyte Irbesartan Spironolactone Oxygen Taurine All Other Therapeutic Products Atenolol SS SS SS C C C C C C C Date:03/18/03ISR Number: 4077977-XReport Type:Expedited (15-DaCompany Report #DCC03003 BAC Age:51 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 10 MG ORAL PT Report Source Product Role Difficulty In Walking Muscle Spasticity Consumer Other Baclofen Tablets, Usp PS Estrace Lasix Xanax Effexor Detrol Loricet C C C C C C Pharmaceutical Product Complaint Manufacturer Route ORAL Date:03/20/03ISR Number: 4080533-0Report Type:Expedited (15-DaCompany Report #20031307 Age: Gender: I/FU:I Outcome PT Dose Duration Required Drug Withdrawal Syndrome Intervention to Medical Device INTRATHECAL DAILY, Report Source Product Role Foreign Health Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Prevent Permanent INTRATHECAL Impairment/Damage Complication Professional Pharmaceutical Product Complaint Date:03/20/03ISR Number: 4080569-XReport Type:Expedited (15-DaCompany Report #20031298 Age:22 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Drug Withdrawal Syndrome Initial or Prolonged Heart Rate Increased INTRATHECAL INTRATHECAL Post Procedural Complication Pyrexia Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Company Representative Date:03/20/03ISR Number: 4080761-4Report Type:Expedited (15-DaCompany Report #PHBS2003CH02731 Age:32 YR Gender:Female I/FU:I Outcome Other 22-Aug-2005 Page: 163 PT Abortion Spontaneous Complications Of Maternal 12:15 PM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Exposure To Therapeutic Drugs Maternal Drugs Affecting Foetus Report Source Product Role Unintended Pregnancy Foreign Lioresal(Baclofen) PS Manufacturer Route Manufacturer Route Duration 30 MG/DAY Health Professional Other Date:03/26/03ISR Number: 4083983-1Report Type:Expedited (15-DaCompany Report #2003CG00392 Age:80 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 10 MG QD PO Initial or Prolonged 20 MG QD PO PT Report Source Product Role Abdominal Distension Foreign Zestril PS ORAL Abnormal Faeces Health Mopral SS ORAL Anorexia Professional Bricanyl SS Cardioactive Drug Level Lasilix SS ORAL Increased Digoxine SS ORAL Drug Interaction Rilutek SS ORAL Electrocardiogram St Isoptine SS ORAL Segment Depression Hexaquine SS ORAL Nausea Levothyrox SS ORAL Oxygen Saturation Lioresal Ciba-Geigy SS ORAL Decreased Kardegic SS ORAL Renal Impairment Atrovent SS RESPIRATORY (INHALATION) C-Reactive Protein 2 PUFF DAILY Increased Other IH 10 MG QD PO 0.25 MG QD PO 50 MG TID PO 40 MG BID PO 2 DF TID PO 75 UG QD PO 2 DF DAILY PO 160 MG QD PO RESPIRATORY (INHALATION) Speech Disorder 1PUFF DAILY Tongue Dry IH Vomiting Solupred Deroxat SS SS Forlax SS ORAL 20 MG QD PO Date:03/27/03ISR Number: 4086939-8Report Type:Expedited (15-DaCompany Report #PHFR2003GB01258 Age:84 YR Gender:Male I/FU:I Outcome Dose Other 10 MG, TID, PT Report Source Product Role Obsessive-Compulsive Foreign Baclofen (Baclofen) PS Personality Disorder Health Paranoia Professional Other Co-Codamol Folic Acid Risedronate Sodium (Risedronate Sodium) Perindopril (Perindopril) Aspirne Bumetanide (Bumetanide) C C Manufacturer Route Duration ORAL ORAL C C C C Date:04/04/03ISR Number: 4090087-0Report Type:Expedited (15-DaCompany Report #PHNU2003DE01380 Age:70 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 50 MG/DAY, PT Report Source Product Role Drug Interaction Fatigue Foreign Health Lioresal (Baclofen) Tablet, 10mg PS Pain In Extremity Professional Weight Increased Other Neurontin (Gabapentin) SS ORAL 1800MG/DAY Saroten "Bayer 22-Aug-2005 Page: 164 12:15 PM Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Vital" (Amitriptyline Hydrochloride) L-Thyroxin "Henning Berlin" Candesartan (Candesartan) Oxybutynin (Oxybutynin) SS Bayer Vital C C C Date:04/04/03ISR Number: 4091000-2Report Type:Expedited (15-DaCompany Report #PHNU2003DE01333 Age:5 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 15 MG/DAY, PT Report Source Product Role Coma Hypothermia Foreign Health Lioresal (Baclofen) Tablet PS Manufacturer Route ORAL Professional ORAL Other Date:04/07/03ISR Number: 4089788-XReport Type:Expedited (15-DaCompany Report #03-03-0381 Age:14 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Clonic Convulsion INTRATHECAL 536-107UG Initial or Prolonged Discomfort INTRATHECAL 5 YR Dyspnoea Hyperpyrexia Medical Device Complication Muscle Spasticity Post Procedural Complication Respiratory Rate Increased Report Source Product Role Literature Baclofen PS Health Professional Manufacturer Route Date:04/08/03ISR Number: 4091612-6Report Type:Expedited (15-DaCompany Report #20021163 Age: Gender:Female I/FU:F Outcome Dose Other INTRATHECAL PT Report Source Product Role Burning Sensation Feeling Cold Health Professional Lioresal? Intrathecal(Baclofen Injection) PS Manufacturer Route Manufacturer Route Duration 275 MCG, DAILY, INTRATHECAL Date:04/08/03ISR Number: 4092307-5Report Type:Expedited (15-DaCompany Report #20031346 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Medication Error Initial or Prolonged Respiratory Disorder INTRATHECAL MCG, DAILY, INTRATHECAL 22-Aug-2005 Page: 165 12:15 PM Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/09/03ISR Number: 4092451-2Report Type:Expedited (15-DaCompany Report #DEU-2002-0000223 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Insomnia Tooth Disorder Foreign Other Oxygesic 40 Mg(Oxycodone Hydrochloride) Cr Tablet PS ORAL Neurontin(Gabapentin ) SS ORAL Baclofen(Baclofen) SS Tramal C Duration 40 MG, TID, ORAL 600 MG, Q6H, ORAL 30 MG, DAILY, ORAL Date:04/09/03ISR Number: 4092532-3Report Type:Expedited (15-DaCompany Report #PHNU2003DE00538 Age:31 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Abortion Complications Of Maternal Foreign Health Lioresal(Baclofen) Tablet, 10mg PS Exposure To Therapeutic Drugs Maternal Drugs Affecting Foetus Pregnancy Professional Other Manufacturer Route Duration ORAL SEE IMAGE Date:04/09/03ISR Number: 4092915-1Report Type:Expedited (15-DaCompany Report #20031343 Age: Gender: I/FU:I Outcome Dose Death PT Report Source Product Death Foreign Lioresal Intrathecal Duration Role Manufacturer Route Health INTRATHECAL (Baclofen Injection) PS UNK MCG, Professional DAILY, INTRATHECAL Date:04/15/03ISR Number: 4095246-9Report Type:Expedited (15-DaCompany Report #03-04-0444 Age:9 YR Gender: I/FU:I Outcome PT Dose Duration Hospitalization Accidental Overdose INTRATHECAL 99.8-777UG Initial or Prolonged Blood Pressure Decreased INTRATHECAL 3 YR Other Coma Delayed Recovery From Anaesthesia Haemodynamic Instability Heart Rate Decreased Heart Rate Increased Implant Site Reaction Medical Device Complication Respiratory Depression 22-Aug-2005 Page: 166 12:15 PM Report Source Product Role Literature Baclofen PS Ranidine Scopolamine C C Health Professional Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/15/03ISR Number: 4095976-9Report Type:Expedited (15-DaCompany Report #PHBS2003IT03668 Age:79 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Cardiac Failure Dyspnoea Foreign Health Lioresal (Baclofen) Unknown PS Manufacturer Route Duration ORAL ORAL Professional Other Date:04/17/03ISR Number: 4098157-8Report Type:Expedited (15-DaCompany Report #HQWYE640614APR03 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Drug Withdrawal Syndrome Myocardial Infarction Health Professional Infumorph (Morphine Sulfate, Injection) PS Baclofen (Baclofen, ) SS Manufacturer Route Manufacturer Route Duration INTRADISCAL (INTRASPINAL) Pharmaceutical Product INTRASPINAL Complaint INTRADISCAL (INTRASPINAL) INTRASPINAL Date:04/17/03ISR Number: 4098265-1Report Type:Expedited (15-DaCompany Report #HQWYE640714APR03 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRADISCAL (INTRASPINAL) PT Report Source Product Role Decubitus Ulcer Loss Of Consciousness Health Professional Infumorph (Morphine Sulfate, Injection) PS Baclofen (Baclofen) SS Rhabdomyolysis INTRASPINAL INTRADISCAL (INTRASPINAL) INTRASPINAL Date:04/17/03ISR Number: 4098292-4Report Type:Expedited (15-DaCompany Report #DEU-2002-0000223 Age: Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Insomnia Sleep Disorder Tooth Disorder Foreign Other Oxygesic 40 Mg (Oxycodone Hydrochloride) Cr Tablet PS ORAL Neurontin (Gabapentin) SS ORAL Baclofen SS ORAL Tramal C Manufacturer Route Duration 40 MG, TID, ORAL 600 MG, Q6H, ORAL 30 MG. DAILY ORAL Date:04/21/03ISR Number: 4099464-5Report Type:Expedited (15-DaCompany Report #20031357 Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Coma Initial or Prolonged Overdose INTRATHECAL DAILY, INTRATHECAL 22-Aug-2005 Page: 167 12:15 PM Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/21/03ISR Number: 4099466-9Report Type:Expedited (15-DaCompany Report #20031364 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Decubitus Ulcer Initial or Prolonged Loss Of Consciousness INTRATHECAL DAILY, Overdose INTRATHECAL Rhabdomyolysis Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Morphine C Manufacturer Route Manufacturer Route Date:04/24/03ISR Number: 4102658-3Report Type:Expedited (15-DaCompany Report #ZANA001068 Age:14 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL INTRATRACHEAL PT Report Source Product Role Clonic Convulsion Condition Aggravated Literature Health Zanaflex (Tizanidine Hydrochloride) PS Dyspnoea Professional Baclofen (Baclofen) SS Lorazepam Clonazepam C C INTHC Hyperpyrexia Mechanical Complication Of Implant Medical Device Complication Muscle Spasms Respiratory Rate Increased Date:04/25/03ISR Number: 4101033-5Report Type:Direct Age: Gender: I/FU:I Outcome Dose Duration Other QUARTER TABS QUARTER TABS ORAL PT Medication Error Company Report #USP 55815 Report Source Product Role Metoprolol PS Baclofen SS Manufacturer Route Date:04/28/03ISR Number: 4103900-5Report Type:Expedited (15-DaCompany Report #PHBS2003IT03668 Age:79 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Cardiac Failure Dyspnoea Foreign Health Lioresal (Baclofen)Unknown PS Lanoxin Drops Sintrom Tenoretic C C C Manufacturer Route Duration ORAL 30 MG/DAY, Professional ORAL Other Date:05/02/03ISR Number: 4106535-3Report Type:Expedited (15-DaCompany Report #20031374 Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Meningitis Initial or Prolonged INTRATHECAL MCG, DAILY, Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Intrethecal Morphine C INTRATHECAL 22-Aug-2005 Page: 168 12:15 PM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/02/03ISR Number: 4107134-XReport Type:Expedited (15-DaCompany Report #20031364 Age: Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL PT Report Source Product Role Decubitus Ulcer Loss Of Consciousness Overdose Health Professional Lioresal Intrathecal(Baclofen Injection) PS Morphine C Manufacturer Route Manufacturer Route Manufacturer Route DAILY, Pharmaceutical Product INTRATHECAL Complaint Rhabdomyolysis Date:05/02/03ISR Number: 4107135-1Report Type:Expedited (15-DaCompany Report #20031375 Age:34 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Agitation Initial or Prolonged Atrial Fibrillation Required Confusional State INTRATHECAL 700 MCG, Intervention to Hallucination, Visual DAILY, Prevent Permanent Hyperpyrexia INTRATHECAL Impairment/Damage Hypertension Somnolence Tachycardia Tremor Report Source Product Role Health Professional Lioresal Intrathecal(Baclofen Injection) PS Date:05/02/03ISR Number: 4107136-3Report Type:Expedited (15-DaCompany Report #20031357 Age: Gender:Female I/FU:F Outcome PT Dose Duration Hospitalization Depressed Level Of Initial or Prolonged Consciousness INTRATHECAL DAILY, Nausea INTRATHECAL Overdose Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Vomiting Date:05/07/03ISR Number: 4109166-4Report Type:Expedited (15-DaCompany Report #PHBS2003IE4292 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Depression Mania Foreign Health Professional Other Lioresal(Baclofen) Solution PS Manufacturer Route Manufacturer Route Date:05/07/03ISR Number: 4109598-4Report Type:Expedited (15-DaCompany Report #HQWYE931328APR03 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Meningitis Health Professional Infumorph (Morphine Sulfate, Injection) PS Baclofen (Balofen, ) SS Duration INTRASPINAL INTRASPINAL 22-Aug-2005 Page: 169 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/07/03ISR Number: 4109850-2Report Type:Expedited (15-DaCompany Report #20031379 Age: Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Role Treatment Noncompliance Health Professional Lioresal Intrathecal (Baclofen Inje) PS Oral Baclofen C Manufacturer Route Manufacturer Route Manufacturer Route Duration INTRATHECAL DAILY, INTRATHECAL Date:05/12/03ISR Number: 4111021-0Report Type:Expedited (15-DaCompany Report #HQWYE64061APR03 Age: Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Drug Withdrawal Syndrome Myocardial Infarction Health Professional Infumorph (Morphine Sulfate, Injection) PS Baclofen (Baclofen,) SS Duration INTRASPINAL INTRA-UTERINE INTRASPINAL Date:05/14/03ISR Number: 4114069-5Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Other PT Company Report #CTU 193045 Report Source Product Role Baclofen 5mg Bid X 7 Days Then 10mg Bid PS Duration Abnormal Behaviour Confusional State 5MG BID X 7 Restlessness DAYS THEN Speech Disorder 10MG BID Urinary Tract Infection Date:05/15/03ISR Number: 4112986-3Report Type:Expedited (15-DaCompany Report #20031384 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged DAILY, Required INTRATHECAL Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Agitation Coma Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route Headache Overdose Swelling Date:05/15/03ISR Number: 4113334-5Report Type:Expedited (15-DaCompany Report #20031397 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Affect Lability Initial or Prolonged Depression INTRATHECAL DAILY, Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS INTRATHECAL Date:05/19/03ISR Number: 4115291-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB01925 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Aphonia Foreign Health Lioresal(Baclofen) Tablet PS Duration 5 MG, BID, Professional ORAL Other 22-Aug-2005 Page: 170 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/03ISR Number: 4122338-8Report Type:Expedited (15-DaCompany Report #20031387 Age: Gender:Male I/FU:I Outcome Dose Duration Life-Threatening INTRATHECAL PT Report Source Product Role Drug Withdrawal Syndrome Migration Of Implant Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route DAILY, Muscle Spasticity INTRATHECAL Myoclonus Rebound Effect Date:06/04/03ISR Number: 4123307-4Report Type:Direct Age:60 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 2MG BID Initial or Prolonged 10MG TID PT Company Report #CTU 194851 Report Source Product Role Dizziness Haloperidol PS Syncope Baclofen SS Guaifenesin Atenolol Lorazepam Meclizine Venlafaxine Fosinopril Hctz Fosinopril C C C C C C C C Date:06/04/03ISR Number: 4124610-4Report Type:Expedited (15-DaCompany Report #20031416 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Medication Error Initial or Prolonged Muscle Spasms INTRATHECAL MCG, DAILY, Tachycardia INTRATHECAL Report Source Product Role Health Professional Lioresal (Baclofen Injection) PS Date:06/12/03ISR Number: 4128745-1Report Type:Expedited (15-DaCompany Report #PHBS2003BR05490 Age:53 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Facial Palsy Foreign Consumer Lioresal (Baclofen) Tablet PS 10 MG/DAY, Other ORAL Fluoxetine Hydrochloride (Fluoxetine Hydrochloride) Pyridoxine Hydrochloride Naprosyn Omeprazole (Omeprazole) Alprazolam (Alprazolam) Date:06/13/03ISR Number: 4129705-7Report Type:Expedited (15-DaCompany Report #20031406 Age: Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 171 Manufacturer Route Duration 12:15 PM PT Blood Pressure Increased Device Failure C C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Drug Withdrawal Syndrome Heart Rate Increased Hyperhidrosis Dose INTRATHECAL Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Duration Muscle Spasms Muscle Spasticity UNK MCG, DAILY, INTRATHECAL Date:06/16/03ISR Number: 4130141-8Report Type:Expedited (15-DaCompany Report #03-06-0687 Age:46 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SEE IMAGE PT Report Source Product Role Blood Pressure Increased Feeling Abnormal Health Professional Baclofen - Ipi Tablets PS ORAL High Density Lipoprotein Decreased Hypokalaemia Sinus Tachycardia Date:06/16/03ISR Number: 4130826-3Report Type:Expedited (15-DaCompany Report #20031422 Age:9 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL PT Device Failure Lethargy Overdose MCG, DAILY, Somnolence Report Source Product Role Health Professional Lioresal Intrathecal(Baclofen Injection) PS INTRATHECAL Vomiting Date:06/20/03ISR Number: 4133795-5Report Type:Expedited (15-DaCompany Report #20031423 Age: Gender:Male I/FU:I Manufacturer Route Outcome PT Dose Duration Hospitalization Apnoeic Attack Initial or Prolonged Blood Pressure Decreased INTRATHECAL DAILY, Catheter Related INTRATHECAL Complication Drug Ineffective Pain Paralysis Somnolence Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Dilaudid Clonidine C C Manufacturer Route Manufacturer Route Date:06/27/03ISR Number: 4138389-3Report Type:Expedited (15-DaCompany Report #PHFR2003GB01925 Age: Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Aphonia Foreign Health Lioresal(Baclofen) Tablet PS Duration 5 MG, BID, Professional ORAL Other 22-Aug-2005 Page: 172 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/30/03ISR Number: 4138358-3Report Type:Direct Age:35 YR Gender:Female I/FU:I Outcome Dose PT Company Report #CTU 112871 Report Source Product Role Blacofen 10mg PS Manufacturer Route Manufacturer Route Duration Dizziness 1 TWICE A DAY Medication Error Nausea Date:07/08/03ISR Number: 4145177-0Report Type:Expedited (15-DaCompany Report #PHNU2003DE02314 Age:68 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Dizziness Drug Interaction Eye Rolling Foreign Study Health Esidrix (Hydrochlorothiazide ) Tablet PS ORAL Fall Professional Hypertension Orthostatic Hypotension Other Baclofen (Baclofen, Baclofen) SS ORAL Benalapril (Enalapril) Tablet, 5mg SS ORAL Doxepin (Doxepin) Capsule SS ORAL 25 MG, QD, ORAL 25 MG, ORAL Tremor 5 MG, QD ORAL 75 MG, QD, ORAL Celebrex Capsule Metoclopramide (Metoclopramide) Solution C C Date:07/08/03ISR Number: 4145181-2Report Type:Expedited (15-DaCompany Report #PHBS2003JP06722 Age:37 YR Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Other Depressed Level Of Consciousness Muscular Weakness Sleep Apnoea Syndrome Foreign Health Professional Other Lioresal (Baclofen) PS Date:07/14/03ISR Number: 4148239-7Report Type:Expedited (15-DaCompany Report #20031447 Age:22 YR Gender: I/FU:I Outcome Dose Death INTRATHECAL PT Report Source Product Role Death Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Duration MCG, DAILY, INTRATHECAL Date:07/15/03ISR Number: 4149280-0Report Type:Expedited (15-DaCompany Report #PHNU2003DE02530 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 30 MG, QID, 22-Aug-2005 Page: 173 12:15 PM PT Report Source Product Role Faecaloma Intestinal Obstruction Foreign Health Lioresal (Baclofen) Unknown PS Professional Other Duragesic (Fentanyl) SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/16/03ISR Number: 4150063-6Report Type:Expedited (15-DaCompany Report #PHBS2003JP06722 Age:37 YR Gender:Female I/FU:F Outcome PT Dose Duration Hospitalization Depressed Level Of Initial or Prolonged Consciousness INTRATHECAL INTRATHECAL Muscular Weakness Sleep Apnoea Syndrome Report Source Product Role Foreign Health Lioresal Intrathecal $Me(Baclofen)Ampoulr PS Manufacturer Route Manufacturer Route Manufacturer Route Professional Other Date:07/16/03ISR Number: 4150797-3Report Type:Expedited (15-DaCompany Report #PHNU2003DE02627 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Diarrhoea Incontinence Foreign Health Lioresal (Baclofen) PS Muscle Spasticity Professional Other Duration 10 MG, TID Date:07/17/03ISR Number: 4150464-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE01380 Age:70 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 50 MG/DAY, PT Report Source Product Role Drug Interaction Fatigue Foreign Health Lioresal(Baclofen) Tablet, 10 Mg PS Pain In Extremity Professional Weight Increased Other Neurontin (Gabapentin) SS ORAL ORAL 1800 MG/DAY, Saroten "Bayer Vital" (Amitriptyline Hydrochloride) L-Thyroxin "Henning Berlin" Candesartan (Candesartan) SS C C Bayer Vital Oxybutynin (Oxybutynin) C Date:07/18/03ISR Number: 4152559-XReport Type:Expedited (15-DaCompany Report #20031457 Age:32 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL PT Clonus Drug Withdrawal Syndrome Hyperreflexia 420 MCG, Hypertonia Report Source Product Role Health Professional Lioresal Intrathecal(Baclofen Injection) PS Baclofen (Baclofen) Diazepam (Diazepam) C C DAILY, Pruritus INTRATHECAL; Pyrexia 200 UG/DAY Tachycardia Date:07/22/03ISR Number: 4154090-4Report Type:Expedited (15-DaCompany Report #PHNU2003DE02530 Age: Gender:Female I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 174 12:15 PM PT Abdominal Distension Constipation Gastrointestinal Motility Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Disorder Intestinal Obstruction Vomiting Dose Report Source Product Role Foreign Lioresal (Baclofen) PS Health Professional Other Duragesic (Fentanyl) Sirdalud SS C Manufacturer Route Manufacturer Route Manufacturer Route Duration SEE IMAGE Date:07/28/03ISR Number: 4157797-8Report Type:Expedited (15-DaCompany Report #20031464 Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Catheter Related Initial or Prolonged Complication INTRATHECAL DAILY, Convulsion INTRATHECAL Meningitis Muscle Spasticity Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Date:07/30/03ISR Number: 4160273-XReport Type:Expedited (15-DaCompany Report #PHBS2003DE07067 Age: Gender:Male I/FU:I Outcome PT Dose Duration Life-Threatening Autonomic Nervous System Hospitalization Imbalance Initial or Prolonged Cardiac Failure INTRATHECAL SEE IMAGE Catheter Related Complication Device Failure Dialysis Disseminated Intravascular Coagulation Drug Withdrawal Syndrome Hyperpyrexia Hypertension Hypotension Metabolic Acidosis Report Source Product Role Foreign Literature Health Lioresal Intrathecal $Me (Baclofen) Ampoule PS Professional Multi-Organ Failure Myocardial Infarction Myoclonus Pain Pneumonia Psychomotor Hyperactivity Renal Failure Respiratory Failure Rhabdomyolysis Tachycardia Date:07/30/03ISR Number: 4160277-7Report Type:Expedited (15-DaCompany Report #20031467 Age: Gender: I/FU:I Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 175 12:15 PM PT Apnoea Autonomic Nervous System Imbalance Cardiac Failure Coagulopathy Drug Withdrawal Syndrome Hyperhidrosis FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypertension Hypertonia Hypotension Dose INTRATHECAL Report Source Product Role Foreign Health Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route Duration Myocardial Infarction Myopathy 1220 MCG, Pain Professional DAILY, Pneumonia INTRATHECAL Pyrexia Renal Failure Tachycardia Date:07/30/03ISR Number: 4160283-2Report Type:Expedited (15-DaCompany Report #20031343 Age: Gender: I/FU:F Outcome Dose Death INTRATHECAL PT Report Source Product Role Foreign Health Lioresal Intrathecal (Baclofen Injection) PS Duration Cardiac Failure Pneumonia , DAILY, Professional INTRATHECAL Date:07/30/03ISR Number: 4160943-3Report Type:Expedited (15-DaCompany Report #20031470 Age: Gender: I/FU:I Outcome PT Dose Duration Life-Threatening Coagulopathy Hospitalization Coma Initial or Prolonged Drug Withdrawal Syndrome INTRATHECAL MCG, DAILY, Required Hypertonia INTRATHECAL Intervention to Hypotension Prevent Permanent Myopathy Impairment/Damage Pyrexia Respiratory Disorder Sepsis Tachycardia Report Source Product Role Literature Health Professional Lioresal Intrathecal(Baclofen Injection) PS Date:07/30/03ISR Number: 4167827-5Report Type:Expedited (15-DaCompany Report #PHBS2003US07039 Age:45 YR Gender:Male I/FU:I Outcome Dose Duration Death Hospitalization Initial or Prolonged 22-Aug-2005 Page: 176 12:15 PM PT Report Source Product Role Cardio-Respiratory Arrest Coma Device Failure Disseminated Intravascular Coagulation Drug Withdrawal Syndrome Hypotension Lung Disorder Muscle Rigidity Muscle Spasticity Rhabdomyolysis Tachycardia Urosepsis Literature Health Professional Lioresal Intrathecal (Baclofen) Ampoule PS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/01/03ISR Number: 4163066-2Report Type:Expedited (15-DaCompany Report #2003-02108 Age:2 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other 12.5MG/2.5ML PT Report Source Product Role Abdominal Pain Upper Accidental Overdose Aggression Consumer Baclofen (Watson Laboratories)(Baclof en) Tablet, 20mg PS Manufacturer Route ORAL Dyskinesia QAM, 5MG/ML Electroencephalogram QHS, ORAL Abnormal Hallucination Headache Insomnia Lethargy Medication Error Pruritus Respiratory Rate Decreased Scratch Screaming Date:08/04/03ISR Number: 4163552-5Report Type:Periodic Age:52 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged 60 MG DAILY Company Report #0254-02(0) PT Report Source Product Role Manufacturer Route Dehydration Grand Mal Convulsion Foreign Health Professional Baclofen Tablets (Unknown Strength) Usp (Danbury/Watson) PS ORAL Cannador SS ORAL Dantrolene SS ORAL PO 8 DF DAILY PO 150 MG DAILY PO Date:08/04/03ISR Number: 4163554-9Report Type:Periodic Age:55 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged 60 MG DAILY Company Report #0255-02(0) PT Report Source Product Role Manufacturer Route Atrial Fibrillation Dehydration Grand Mal Convulsion Foreign Health Professional Baclofen Tablets Usp (Unknown Strength) (Danbyry/Watson) PS ORAL Placebo Therapy SS ORAL Lansoprazole Viagra C C Infection PO 10 MG DAILY PO Date:08/06/03ISR Number: 4166353-7Report Type:Expedited (15-DaCompany Report #20031379 Age: Gender:Male I/FU:F Outcome Dose Death INTRATHECAL PT Report Source Product Role Accident Atrophy Health Professional Lioresal Intrathecal (Baclofen Injection) PS Baclofen C Duration DAILY, Chronic Obstructive INTRATHECAL Pulmonary Disease Emphysema Injury Pulmonary Congestion Pulmonary Oedema 22-Aug-2005 Page: 177 12:15 PM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/11/03ISR Number: 4166762-6Report Type:Direct Age:22 YR Gender:Female I/FU:I Outcome Dose Other INTRATHECAL PT Company Report #CTU 199720 Report Source Product Role Baclofen Inj PS Manufacturer Route Duration Depressed Level Of 5000MCG IT Consciousness Date:08/11/03ISR Number: 4167972-4Report Type:Periodic Age:32 MON Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 75MG QD ORAL Company Report #03-03-0386 PT Report Source Product Role Manufacturer Route Anorexia Coma Consumer Baclofen - Ipi Tablets PS Ipi ORAL Tegretol Dilantin Aspirin Zyrtec Benadryl Vancomycin Zantac Gentamicin Zofran Lovenox Pulmicort C C C C C C C C C C C Diarrhoea Hypoventilation Malaise Muscle Twitching Overdose Vomiting Date:08/12/03ISR Number: 4166043-0Report Type:Expedited (15-DaCompany Report #PHBS2003NL08166 Age:8 YR Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Duration Hypernatraemia Liver Function Test 2.5 mg, BID Abnormal Pyrexia Restlessness Rhabdomyolysis Date:08/13/03ISR Number: 4169349-4Report Type:Expedited (15-DaCompany Report #20031485 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL PT Blood Pressure Increased Muscle Spasticity Nausea 1200 MCG, Post Procedural Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) - 2000mcg/Ml PS DAILY, Complication INTRATHECAL Pyrexia Reflexes Abnormal Urinary Tract Infection Date:08/14/03ISR Number: 4168190-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE02970 Age:15 YR Gender:Male I/FU:I Outcome Other 22-Aug-2005 Page: 178 PT Alanine Aminotransferase Increased Aspartate Aminotransferase Increased 12:15 PM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Gamma-Glutamyltransferase Increased Liver Function Test Dose Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Novartis Sector: Pharma ORAL Manufacturer Route Route Duration Abnormal UNK Lioresal SS 50mg/day Date:08/22/03ISR Number: 4173452-2Report Type:Direct Age: Gender: I/FU:I Outcome Dose PT Company Report #CTU 200544 Report Source Product Role Baclofen Pump PS Duration Activities Of Daily Living Impaired Body Temperature Increased Cognitive Disorder Confusional State Diplopia Drug Withdrawal Syndrome Malaise Medication Error Memory Impairment Speech Disorder Tachycardia Thinking Abnormal Vomiting Date:08/25/03ISR Number: 4172857-3Report Type:Expedited (15-DaCompany Report #PHBS2003TW08684 Age:73 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Abnormal Behaviour Initial or Prolonged Apathy UNKNOWN 15 mg/day Atrial Fibrillation UNKNOWN 1500 mg/day Report Source Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Acetaminophen C UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN Creatinine Renal 300 mg/day Clearance Increased 5 mg/day Depressed Level Of 7.5 mg, BID Consciousness 5 mg/day Locked-In Syndrome Mental Impairment 10 mg/day Proteinuria Speech Disorder Urinary Incontinence Carbamazepine C Glipizide C Meloxicam C Diazepam C Zolpidime Hemitartare C Date:08/25/03ISR Number: 4178410-XReport Type:Expedited (15-DaCompany Report #20031498 Age: Gender:Male I/FU:I Outcome Dose Duration Life-Threatening INTRATHECAL PT Cardiac Arrest Emotional Distress MCG, DAILY, Loss Of Consciousness INTRATHECAL Medication Error Overdose 22-Aug-2005 Page: 179 12:15 PM Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/26/03ISR Number: 4179648-8Report Type:Expedited (15-DaCompany Report #PHBS2003TW08684 Age:73 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 15 MG/DAY Initial or Prolonged PT Report Source Product Role Apathy Foreign Baclofen (Baclofen) PS Atrial Fibrillation Back Pain Depressed Level Of Consciousness Electroencephalogram Abnormal Insomnia Locked-In Syndrome Mental Impairment Pain Proteinuria Speech Disorder Urinary Incontinence Literature Health Professional Other Acetaminophen Carbamazepine Glipizide (Glipizide) Meloxicam (Meloxicam) Diazepam Zolpidine Hemitartare (Zolpidem) C C Manufacturer Route C C C C Date:08/28/03ISR Number: 4175020-5Report Type:Expedited (15-DaCompany Report #PHNU2003DE01333 Age:5 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 15mg/day Other PT Coma Hypothermia Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Manufacturer Route Pneumonia Aspiration Date:08/28/03ISR Number: 4176562-9Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Report Source PT Company Report #CTU 200904 Report Source Product Role Baclofen (Generic ) For Lioresal PS Duration Pharmaceutical Product Complaint 20MG 1 PO QHS, 10MG 1 PIO TID, 10MG ORAL 1 BID PRN Date:08/29/03ISR Number: 4179803-7Report Type:Expedited (15-DaCompany Report #20031501 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL PT Report Source Product Role Drug Withdrawal Syndrome Medication Error Postoperative Infection Health Professional Lioresal Intrathecal(Baclofen Injection) PS Manufacturer Route Manufacturer Route DAILY, INTRATHECAL Date:08/29/03ISR Number: 4182478-4Report Type:Expedited (15-DaCompany Report #2003UW10598 Age:13 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Dysphagia Hallucination Respiratory Arrest Health Professional Iressa Iressa Baclofen PS SS SS Clonidine SS START DATE IS PRIOR TO 02-AUG-2003 START DATE IS PRIOR TO 02-AUG-2003 22-Aug-2005 Page: 180 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Methylphenidate SS Lorazepam SS Zoloft SS Benadryl SS START DATE IS PRIOR TO 02-AUG-2003 START DATE IS PRIOR TO 02-AUG-2003 START DATE IS PRIOR TO 02-AUG-2003 START DATE IS PRIOR TO 02-AUG-2003 Date:09/03/03ISR Number: 4184486-6Report Type:Expedited (15-DaCompany Report #20031508 Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Back Disorder Initial or Prolonged Catheter Related INTRATHECAL DAILY, Complication INTRATHECAL Drug Withdrawal Syndrome Mental Status Changes Muscle Rigidity Muscle Spasticity Oedema Pyrexia Rebound Effect Stress Report Source Product Role Health Professional Lioresal (Baclofen Injection) PS Oral Baclofen C Manufacturer Route Date:09/08/03ISR Number: 4180743-8Report Type:Expedited (15-DaCompany Report #PHBS2003NL09276 Age:62 YR Gender:Female I/FU:I Outcome Dose Other PT UNKNOWN Drug Interaction Hypotonia 12.5 mg, BID Muscle Twitching Muscular Weakness 12.5 mg/d UNKNOWN 2.5 mg/kg/d UNKNOWN 5 mg/kg/d UNKNOWN 0.25 ug/kg/d UNKNOWN 10 ug/d UNKNOWN 0.6 mg/kg/d UNKNOWN 35 mg/d UNKNOWN 0.6 - 1.0 UNKNOWN Report Source Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Baclofen SS Novartis Sector: Pharma Propofol SS Propofol SS Sufentanil SS Sufentanil SS Atracurium SS Atracurium SS Isoflurane SS Morphine SS Diazepam C Prednisone C Levothyroxine C Vitamin B12 C Cefuroxime C Clindamycin C Dexamethasone C Duration vol% UNKNOWN 8 mg/d UNKNOWN 7.5 mg, BID UNKNOWN 20 mg, QD UNKNOWN 25 ug, QD UNKNOWN INTRAVENOUS 1500 mg/d INTRAVENOUS 600 mg/d INTRAVENOUS 10 mg/d 22-Aug-2005 Page: 181 12:15 PM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/09/03ISR Number: 4186531-0Report Type:Direct Age: Gender: I/FU:I Outcome Dose Duration Hospitalization INTRAVENOUS 1 G IV Initial or Prolonged SEE IMAGE Required Intervention to Prevent Permanent Impairment/Damage PT Company Report #CTU 201499 Report Source Drug Toxicity Q12 Mental Status Changes Product Role Vancomycin Iv PS Baclofen SS 10 Mg Qid Manufacturer Route Manufacturer Route Manufacturer Route Renal Failure Acute Date:09/09/03ISR Number: 4188462-9Report Type:Expedited (15-DaCompany Report #20031516 Age: Gender:Male I/FU:I Outcome Dose Death INTRATHECAL PT Report Source Product Role Death Health Professional Lioresal Intrathecal(Baclofen Injection) PS Duration MCG, DAILY, INTRATHECAL Date:09/09/03ISR Number: 4188463-0Report Type:Expedited (15-DaCompany Report #20031515 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Blood Creatine Initial or Prolonged Phosphokinase Increased INTRATHECAL DAILY, Drug Withdrawal Syndrome INTRATHECAL Muscle Spasticity Pruritus Pyrexia Rebound Effect Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Oral Baclofen C Date:09/09/03ISR Number: 4188465-4Report Type:Expedited (15-DaCompany Report #20031512 Age: Gender:Male I/FU:I Outcome PT Dose Duration Required Respiratory Disorder Intervention to Rhabdomyolysis INTRATHECAL DAILY, Prevent Permanent INTRATHECAL Impairment/Damage Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route Date:09/10/03ISR Number: 4188488-5Report Type:Expedited (15-DaCompany Report #20031517 Age: Gender:Male I/FU:I Outcome Dose Death INTRATHECAL PT Report Source Product Role Death Health Professional Lioresal Intrathecal (Baclofen Injection) PS Duration MCG, DAILY, INTRATHECAL Date:09/11/03ISR Number: 4200753-1Report Type:Periodic Age:61 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 10 MG, BID; ORAL 365 Company Report #2003163149US PT Report Source Product Role Renal Failure Acute Health Professional Bextra (Valdecoxib) Tablet PS DAY Glucophage 22-Aug-2005 Page: 182 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Metformin Hydrochloride) SS ORAL Valium (Diazepam) SS ORAL Baclofen (Baclofen) SS Diovan (Valsartan) SS Zanaflex (Tizanidine Hydrochloride) SS Hydrocodone (Hydrocodone) SS Niacin (Nicotinic Acid) SS ORAL Vasotec (Enalapril Maleate) SS ORAL Potassium Chloride (Potassium Chloride) SS ORAL 500 MG, BID; ORAL UNK, UNK; ORAL UNKNOWN UNK, UNK, UNK UNKNOWN UNK, UNK, UNK ORAL UNK, UNK; ORAL UNKNOWN UNK, UNK, UNK 250 MG, QD; ORAL 10 UNK, UNK; ORAL 8 UNK, BID; ORAL Tolterodine L-Tartrate Ultram (Tramadol Hydrochloride) Protonix (Pyritinol) Lasix Norvasc (Amlodipine Besilate) Lortab C C C C C C Date:09/12/03ISR Number: 4190173-0Report Type:Expedited (15-DaCompany Report #2003CG01252 Age: Gender:Male I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Optic Neuropathy Foreign Health Professional Other Marcaine Lioresal "Ciba-Geigy" Catapressan PS Date:09/23/03ISR Number: 4195382-2Report Type:Direct Age:39 YR Gender:Female I/FU:I Outcome Dose PT SS SS Ciba-Geigy Product Role Manufacturer Baclofen PS Upsher Smiths Laboratoires 12:15 PM Route Company Report #CTU 202278 Report Source Duration Asthenia Decreased Appetite Feeling Abnormal Gastrointestinal Disorder Hyperaesthesia Pain Pharmaceutical Product Complaint Sleep Disorder Vision Blurred Vomiting 22-Aug-2005 Page: 183 Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/23/03ISR Number: 4195536-5Report Type:Direct Age:64 YR Gender:Female I/FU:I Outcome Dose Duration Required 5 MG X 2 Intervention to (ONLY) Prevent Permanent Impairment/Damage PT Company Report #CTU 202368 Report Source Blood Calcium Product Role Baclofen PS Manufacturer Route Manufacturer Route Manufacturer Route Blood Chloride Blood Creatinine Blood Glucose Blood Potassium Blood Sodium Blood Urea Depressed Level Of Consciousness Haematocrit Mental Status Changes Pco2 Prescribed Overdose Date:09/24/03ISR Number: 4198354-7Report Type:Expedited (15-DaCompany Report #20031525 Age:38 YR Gender:Female I/FU:I Outcome Dose Death INTRATHECAL PT Report Source Product Role Death Health Professional Company Lioresal Intrathecal(Baclofen Injection) PS Duration UNK MCG, Representative DAILY, INTRATHECAL Date:09/24/03ISR Number: 4198922-2Report Type:Expedited (15-DaCompany Report #20031512 Age: Gender:Male I/FU:F Outcome PT Dose Duration Required Catheter Related Intervention to Complication INTRATHECAL DAILY, Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Prevent Permanent INTRATHECAL Impairment/Damage Respiration Abnormal Rhabdomyolysis Therapeutic Response Decreased Oral Baclofen C Date:09/29/03ISR Number: 4202431-1Report Type:Expedited (15-DaCompany Report #20031523 Age: Gender:Female I/FU:I Outcome PT Dose Duration Required Constipation Intervention to Drug Ineffective Prevent Permanent Dysarthria INTRATHECAL MCG, DAILY, Impairment/Damage Muscle Spasms INTRATHECAL Pruritus Pyrexia Report Source Product Role Health Professional Lioresal Intrathecal(Baclofen Injection) PS Date:09/29/03ISR Number: 4202432-3Report Type:Expedited (15-DaCompany Report #20031520 Age:50 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 184 12:15 PM PT Anxiety Catheter Related Complication Drug Withdrawal Syndrome Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose INTRATHECAL Muscle Spasticity Nausea Pruritus Report Source Product Role Pyrexia Vomiting Health Professional Lioresal Intrathecal(Baclofen Injection) PS Manufacturer Route Manufacturer Route Duration 265 MCG, DAILY, INTRATHECAL Date:10/01/03ISR Number: 4203623-8Report Type:Expedited (15-DaCompany Report #2003039929 Age:64 YR Gender:Unknown I/FU:I Outcome Dose Death Other ORAL PT Report Source Product Role Cardio-Respiratory Arrest Completed Suicide Literature Health Doxepin (Caps) (Doxepin) PS ORAL Professional Baclofen (Baclofen) SS ORAL Quetiapine (Quetiapine) SS ORAL All Other Therapeutic Products SS ORAL Duration ORAL ORAL ORAL Date:10/07/03ISR Number: 4202376-7Report Type:Expedited (15-DaCompany Report #PHRM2003FR02525 Age:35 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 20 mg/day PT Cytolytic Hepatitis Hepatic Necrosis Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Di-Antalvic 6 DF/day 87840MIN SS ORAL Date:10/07/03ISR Number: 4210074-9Report Type:Periodic Age:51 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 10 MG ORAL PT Report Source Product Role Drug Ineffective Muscle Spasticity Consumer Other Baclofen Tablets, Usp PS Estrace Lasix Xanax Effexor Detrol Loricet C C C C C C Date:10/07/03ISR Number: 4210085-3Report Type:Periodic Age:86 YR Gender:Female I/FU:I Outcome Dose Other Company Report #DCC03003 BAC 22-Aug-2005 Page: 185 Route ORAL Company Report #DCC 03-010 BAC PT Report Source Product Role Confusional State Somnolence Consumer Baclofen Tablets, Usp PS Diovan Pravachol Tums Baby Aspirin C C C C Manufacturer Route Duration 10 MG QID ORAL Manufacturer 1 DAY 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/07/03ISR Number: 4210088-9Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 20 MG QD ORAL Other Company Report #DCC 03-008 BAC20 PT Report Source Product Role Hallucinations, Mixed Health Professional Baclofen Tablets, Usp 20 Mg PS Zonegren Carbatrol Risperdal C C C Manufacturer Route ORAL Date:10/08/03ISR Number: 4203687-1Report Type:Expedited (15-DaCompany Report #PHNU2003DE03532 Age:57 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Lioresal PS Novartis Sector: Pharma Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Route Duration Thrombocytopenia UNKNOWN Date:10/08/03ISR Number: 4203695-0Report Type:Expedited (15-DaCompany Report #PHRM2003FR02525 Age:35 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 20 mg/day PT Report Source Cytolytic Hepatitis Hepatic Necrosis Di-Antalvic 6 DF/day Date:10/08/03ISR Number: 4207348-4Report Type:Direct Age: Gender: I/FU:I Outcome Dose SS ORAL 87840MIN PT Company Report #USP 080176 Report Source Product Role Baclofen Baclofen PS SS Duration Medication Error Manufacturer Route Date:10/08/03ISR Number: 4207422-2Report Type:Expedited (15-DaCompany Report #20031542 Age: Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Role Medication Error Overdose Health Professional Lioresal Intrathecal(Baclofen Injection) PS Manufacturer Route Duration INTRAVENOUS BOLUS 75 MCG, BOLUS EVERY 8 MINUTES Date:10/09/03ISR Number: 4205237-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB03795 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 5 mg, TID PT Report Source Product Role Manufacturer Coma Musculoskeletal Stiffness Health Professional Baclofen PS Novartis Sector: Pharma Aspirine Trimethoprim Salbutamol Oxybutynin C C C C Renal Impairment 22-Aug-2005 Page: 186 12:15 PM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/14/03ISR Number: 4211478-0Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Other Company Report #2003025236 PT Report Source Product Role Convulsion Health Professional Neurontin (Gabapentin) Baclofen (Baclofen) PS SS Manufacturer Route Duration OTHER OTHER Atenolol (Atenolol) Bisacodyl (Bisacodyl) Docusate Sodium (Docusate Sodium) Vitamins Magnesium Gluconate (Magnesium Gluconate) C C C C C Date:10/17/03ISR Number: 4210416-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB03937 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Baclofen PS Novartis Sector: Pharma Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Duration Confusional State Drug Withdrawal Syndrome 20 mg, TID Nightmare Date:10/20/03ISR Number: 4211969-2Report Type:Expedited (15-DaCompany Report #PHBS2003CA11214 Age: Gender:Unknown I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 40 mg, BID Initial or Prolonged PT Convulsion Pyrexia Report Source Sepsis Date:10/20/03ISR Number: 4215525-1Report Type:Expedited (15-DaCompany Report #20031551 Age:57 YR Gender:Male I/FU:I Outcome PT Dose Duration Required Coagulopathy Intervention to Prevent Permanent INTRATHECAL UNK MCG, Impairment/Damage DAILY, Report Source Product Role Foreign Health Professional Lioresal Intrathecal(Baclofen Injection) PS Manufacturer Route INTRATHECAL Date:10/21/03ISR Number: 4215104-6Report Type:Expedited (15-DaCompany Report #PHNU2003DE03532 Age:45 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Duration Thrombocytopenia 20mg/day Date:10/22/03ISR Number: 4213554-5Report Type:Expedited (15-DaCompany Report #PHFR2003GB03912 Age: Gender:Male I/FU:F Outcome Dose Death Other 22-Aug-2005 Page: 187 PT Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Duration Colitis Death Diarrhoea 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/22/03ISR Number: 4213555-7Report Type:Expedited (15-DaCompany Report #PHFR2003GB03795 Age: Gender:Male I/FU:F Outcome Dose Duration Death Hospitalization 5 mg, TID Initial or Prolonged PT Report Source Product Role Manufacturer Cerebrovascular Accident Coma Baclofen PS Novartis Sector: Pharma Musculoskeletal Stiffness Renal Impairment Aspirine Trimethoprim Salbutamol Oxybutynin C C C C Route Date:10/24/03ISR Number: 4217495-9Report Type:Expedited (15-DaCompany Report #PHBS2003JP06722 Age:37 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Depressed Level Of Consciousness Muscular Weakness Sleep Apnoea Syndrome Date:10/24/03ISR Number: 4217514-XReport Type:Direct Age:84 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 20 MG BID -PO Report Source PT Abasia Aphasia Product Role Manufacturer Route Lioresal Intrathecal $Me PS Novartis Sector: Pharma ORAL Company Report #CTU 204544 Report Source Product Role Manufacturer Route Baclofen/Lioresal 20 Mg Ivax-Zenith PS Ivax-Zenith ORAL Asthenia ( 4 DOSES) Convulsion Drooling Feeding Disorder Gait Disturbance Date:10/27/03ISR Number: 4221164-9Report Type:Expedited (15-DaCompany Report #20031565 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Convulsion Dystonia Hypoglycaemia UNK MCG DAILY INTRATHECAL Report Source Product Role Health Professional Lioresal Intrathecal(Baclofen Injection) PS Glucose Oral Baclofen Antibiotics C C C Manufacturer Route Manufacturer Route INTRATHECAL Date:10/28/03ISR Number: 4220492-0Report Type:Direct Age:62 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening PT Blood Glucose Increased Drug Toxicity 20 MG QD IV INTRAVENOUS Company Report #CTU 204679 Report Source Product Role Arsenic Trioxide 0.25 Mg Kg PS Ascorbic Acid 1000 Mg SS Baclofen Ativan Pepcid Prochloperazine Darvocet SS C C C C ASCORBIC ACID IV 22-Aug-2005 Page: 188 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lexapro Norvasc Remeron C C C Date:10/29/03ISR Number: 4221266-7Report Type:Expedited (15-DaCompany Report #PHBS2003US11591 Age:38 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Angiogram Abnormal Blindness Ocular Hyperaemia Retinogram Abnormal Scotoma Report Source Product Role Manufacturer Route Baclofen PS Novartis Sector: Pharma ORAL Mexiletine Hydrochloride Morphine Sulfate Morphine Sulfate SS C C Pentosan Polysulfate Sodium C Gabapentin C Lorazepam C Hydroxyzine Hydrochloride C Glimepiride C Promethazine Hydrochloride C Lidocaine Hydrochloride C Clonidine Hydrochloride C Methadone Hydrochloride C Fluoxetine Hydrochloride C Trazodone C INTRATHECAL UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN INTRAVENOUS 385.27 mg UNKNOWN UNKNOWN UNKNOWN UNKNOWN ORAL ORAL Sucralfate C UNKNOWN Date:10/29/03ISR Number: 4222057-3Report Type:Expedited (15-DaCompany Report #03-10-1333 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 5MG TID PT Report Source Product Role Coma Musculoskeletal Stiffness Foreign Other Baclofen - Ipi Tablets PS Aspirin Trimethoprim Salbutamol Oxybutynin C C C C Renal Impairment Date:10/29/03ISR Number: 4223676-0Report Type:Expedited (15-DaCompany Report #KII-2003-0004111 Age:55 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 189 12:15 PM PT Anticonvulsant Drug Level Below Therapeutic Aphasia Blood Pressure Increased Confusional State Heart Rate Increased Hypoventilation Intentional Misuse Intentional Self-Injury Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lethargy Loss Of Consciousness Miosis Dose Report Source Product Role Health Professional Oxycontin Tablets(Oxycodone Hydrochloride) Cr Tablet PS Manufacturer Route Duration Moaning Multiple Drug Overdose Productive Cough Pulmonary Oedema ORAL ORAL Respiratory Rate Increased Somnolence Toxicologic Test Abnormal Date:11/05/03ISR Number: 4227756-5Report Type:Direct Age:88 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 10 MG QID PRN Initial or Prolonged ORAL PT Demerol (Pethidine Hydrochloride) Baclofen (Baclofen) Risperdal(Risperidon e) Dilantin (Phenytoin Sodium) Soma(Carisoprodol) Methadone(Methadone) SS SS SS SS SS SS Company Report #CTU 205260 Report Source Incoherent Product Role Baclofen 10 Mg PS Asa Oxycodone C C Manufacturer Route ORAL Medication Error Somnolence Date:11/05/03ISR Number: 4229148-1Report Type:Expedited (15-DaCompany Report #K200301699 Age:35 YR Gender:Male I/FU:I Outcome PT Dose Duration Life-Threatening Coma Hospitalization Convulsion TRANSDERMAL 900 MG, Initial or Prolonged Drug Screen Positive TRANSDERMAL Electroencephalogram Report Source Product Role Literature Health Ketalar (Ketamine) Injection, 900mg PS Professional Baclofen(Baclofen) Manufacturer Route Abnormal 900 MG, Overdose TRANSDERMAL 900mg SS Amitriptyline (Amitriptyline) 360mg SS Lidocaine (Lidocaine) 900mg SS Ketoprofen(Ketoprofe n) 1800mg SS TRANSDERMAL Postictal State TRANSDERMAL 360 MG,TRANSDERMA L TRANSDERMAL 900 MG, TRANSDERMAL TRANSDERMAL 1800 MG, TRANSDERMAL Date:11/06/03ISR Number: 4230304-7Report Type:Expedited (15-DaCompany Report #K200301699 Age:35 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged TRANSDERMAL 900 PT Report Source Product Role Coma Convulsion Drug Screen Positive Literature Health Professional Ketalar (Ketamine)Injection , 900 Mg PS Medication Error MG,TRANSDERMA Overdose L Baclofen (Baclofen) 22-Aug-2005 Page: 190 12:15 PM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report TRANSDERMAL 900 Mg SS Amitriptyline (Amitriptyline) 360 Mg SS Lidocaine (Lidocaine) 900 Mg SS Ketoprofen (Ketoprofen) 1800 Mg SS 900 MG, TRANSDERMAL TRANSDERMAL 360 MG, TRANSD3RMAL TRANSDERMAL 900, TRANSDERMAL TRANSDERMAL 1800, MG, TRANSDERMAL Date:11/07/03ISR Number: 4229011-6Report Type:Expedited (15-DaCompany Report #PHFR2003GB04243 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Lioresal PS Novartis Sector: Pharma Manufacturer Route Duration Peptic Ulcer Date:11/07/03ISR Number: 4231764-8Report Type:Expedited (15-DaCompany Report #2003UW14116 Age: Gender:Female I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent 50 MG DAILY Impairment/Damage PO PT Report Source Product Role Alopecia Angina Pectoris Arrhythmia Foreign Health Professional Xylocaine Baclofen Neurontin PS SS SS Blood Pressure Increased Other Cardiac Disorder Nitrostat SS Cardiac Failure Cardiac Valve Disease Atenolol Avapro C C 0.3 Route ORAL Chest Pain Condition Aggravated Disturbance In Attention Dizziness Electrolyte Imbalance Heart Rate Increased Hypotension Memory Impairment Myocardial Infarction Pulmonary Hypertension Restlessness Somnolence Weight Decreased Weight Increased K-Lyte No Match Oxygen Taurine C C C C Date:11/10/03ISR Number: 4233596-3Report Type:Expedited (15-DaCompany Report #200313438GDS Age:35 YR Gender:Male I/FU:I Outcome PT Dose Duration Life-Threatening Areflexia TRANSDERMAL TRANSDERMAL Hospitalization Coma (TRANSCUTANEO Initial or Prolonged Convulsion US) Overdose TRANSDERMAL TRANSDERMAL Report Source Product Role Literature Ketoprofen PS Amitriptyline SS Lidocaine SS Health Professional (TRANSCUTANEO US) TRANSDERMAL TRANSDERMAL (TRANSCUTANEO US) 22-Aug-2005 Page: 191 12:15 PM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report TRANSDERMAL Ketamine SS Baclofen SS TRANSDERMAL (TRANSCUTANEO US) TRANSDERMAL TRANSDERMAL (TRANSCUTANEO US) Date:11/13/03ISR Number: 4234531-4Report Type:Expedited (15-DaCompany Report #PHRM2003FR02941 Age:56 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 60 mg/day PT Report Source Gastric Ulcer Gastrointestinal Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Manufacturer Route Haemorrhage Date:11/13/03ISR Number: 4236035-1Report Type:Expedited (15-DaCompany Report #KII-2003-0005736 Age:28 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Drug Screen Positive Hyperhidrosis Hyperpyrexia Medication Error Multiple Drug Overdose Sinus Tachycardia Somnolence White Blood Cell Count Study Health Professional Other Morphine Sulfate(Similar To Nda 19-516)(Morphine Sulfate) Unknown Soma (Carisoprodol) Valium(Diazepam) Ace Inhibitor Nos() Antihistamine() Nortriptyline(Nortri ptyline) Biguandes() Anticonvulsant() Ssri() Acetaminophen(Parace tamol) Role PS SS SS SS SS SS SS SS SS SS Acetylsalicylic Acid (Acetylsalicylic Acid0 Baclofen(Baclofen) Zanaflex(Tizanidine Hydrochloride) SS SS SS Date:11/13/03ISR Number: 4236056-9Report Type:Expedited (15-DaCompany Report #HQWYE674131OCT03 Age:63 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 5 MG 1X PER 1 Initial or Prolonged DAY 3 YR PT Report Source Product Role Dizziness Drug Interaction Health Professional Biso-Puren (Bisoprolol, Tablet) PS Hiatus Hernia Other Buprenorphine (Buprenorphine, ) SS Lebic (Baclofen, ) SS ORAL Nitrangin Compositum (Glyceryl Trinitrate/Valerian Tincture, ) SS ORAL Vomiting TRANSDERMAL EVERY Manufacturer Route ORAL 35 MCG, 1 3 DAYS 1 YR 10 (TABLETS), ONE DAILY 1 30 DROPS, TID 1 YR YR Nitrendipine 22-Aug-2005 Page: 192 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Nitrendipine, ) SS ORAL 10 MG 2X PER 1 DAY 1 YR Date:11/17/03ISR Number: 4236487-7Report Type:Expedited (15-DaCompany Report #20031567 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Drug Withdrawal Syndrome Initial or Prolonged Lethargy INTRATHECAL MCG, Muscle Spasticity DAILY, Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route INTRATHECAL Date:11/18/03ISR Number: 4236827-9Report Type:Direct Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Catheter Related Initial or Prolonged Complication INTRATHECAL DAILY, Muscle Spasticity INTRATHECAL Pharmaceutical Product Complaint Date:11/18/03ISR Number: 4236896-6Report Type:Direct Age: Gender:Female I/FU:I Outcome PT Dose Duration Required Oedema Peripheral Intervention to INTRATHECAL MCG, DAILY Prevent Permanent INTRATHECAL Impairment/Damage Company Report #CTU 206287 Report Source Product Role Lioresal Intrathecal (Baclofen Injection) PS Company Report #CTU 206278 Report Source Product Role Lioresal Intrathecal (Baclofen Injection) PS Date:11/18/03ISR Number: 4236897-8Report Type:Direct Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Device Failure Initial or Prolonged Drug Ineffective INTRATHECAL MCG, DAILY Company Report #CTU 206277 Report Source Product Role Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route INTRATHECAL Date:11/18/03ISR Number: 4236898-XReport Type:Direct Age: Gender:Male I/FU:I Outcome PT Dose Duration Required Condition Aggravated Intervention to Device Failure INTRATHECAL MCG, DAILY Prevent Permanent Muscle Spasticity INTRATHECAL Impairment/Damage Date:11/18/03ISR Number: 4236899-1Report Type:Direct Age: Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 193 12:15 PM PT Clonus Device Failure Drug Withdrawal Syndrome Hypotension Company Report #CTU 206276 Report Source Product Role Lioresal Intrathecal (Baclofen Injection) PS Company Report #CTU 206275 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscle Spasticity Muscle Twitching Report Source Dose INTRATHECAL Product Role Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route Manufacturer Route Duration MCG, DAILY INTRATHECAL Date:11/18/03ISR Number: 4236900-5Report Type:Direct Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Alcohol Withdrawal Initial or Prolonged Syndrome INTRATHECAL UNK MCG, Device Failure DAILY, Company Report #CTU 206286 Report Source Product Role Lioresal Intrathecal (Baclofen Injection) PS INTRATHECAL Date:11/18/03ISR Number: 4236901-7Report Type:Direct Age: Gender:Male I/FU:I Outcome PT Dose Duration Required Drug Effect Decreased Intervention to Mechanical Complication INTRATHECAL UNK MCG. Prevent Permanent Of Implant DAILY, Impairment/Damage INTRATHECAL Date:11/18/03ISR Number: 4236902-9Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose PT Duration Company Report #CTU 206285 Report Source Product Role Lioresal Intrathecal (Baclofen Injection) PS Company Report #CTU 206284 Report Source Product Role Hospitalization Agitation Initial or Prolonged Device Failure INTRATHECAL UNK MCG, Muscle Spasticity DAILY, Lioresal Intrathecal (Baclofen Injection) PS INTRATHECAL Date:11/18/03ISR Number: 4236903-0Report Type:Direct Age: Gender:Female I/FU:I Outcome PT Dose Duration Required Muscle Spasticity Intervention to INTRATHECAL UNK MCG DAILY Prevent Permanent , INTRATHECAL Impairment/Damage Date:11/18/03ISR Number: 4236904-2Report Type:Direct Age: Gender:Male I/FU:I Outcome PT Dose Duration Required Medication Error Intervention to Muscle Spasticity INTRATHECAL UNK MCG DAILY Prevent Permanent , INTRATHECAL Impairment/Damage 22-Aug-2005 Page: 194 12:15 PM Company Report #CTU 206283 Report Source Product Role Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Company Report #CTU 206282 Report Source Product Role Lioresal Intrathecal (Baclofen Injection) PS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/18/03ISR Number: 4236906-6Report Type:Direct Age: Gender:Female I/FU:I Outcome PT Dose Duration Required Medical Device Intervention to Complication INTRATHECAL UNK MCG, Prevent Permanent Medication Error DAILY, Impairment/Damage INTRATHECAL Date:11/18/03ISR Number: 4236907-8Report Type:Direct Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Medical Device Initial or Prolonged Complication INTRATHECAL UNK MCG, Overdose DAILY, Pharmaceutical Product INTRATHECAL Complaint Date:11/18/03ISR Number: 4236908-XReport Type:Direct Age: Gender:Male I/FU:I Outcome PT Dose Duration Required Medical Device Intervention to Complication INTRATHECAL UNK MCG, Prevent Permanent Muscle Spasticity DAILY, Impairment/Damage INTRATHECAL Company Report #CTU 206281 Report Source Product Role Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route Company Report #CTU 206280 Report Source Product Role Lioresal Intrathecal (Baclofen Injection) PS Company Report #CTU 206279 Report Source Product Role Lioresal Intrathecal (Baclofen Injection) PS Date:11/19/03ISR Number: 4238788-5Report Type:Expedited (15-DaCompany Report #20031495 Age:36 YR Gender:Male I/FU:F Outcome PT Dose Duration Death Abdominal Rigidity Hospitalization Anoxia Initial or Prolonged Anoxic Encephalopathy INTRATRACHEAL MCG, DAILY, Autonomic Nervous System INTRATHECAL Imbalance Cardiac Disorder Cervical Vertebra Injury Device Failure Feeling Abnormal Lung Disorder Overdose Respiratory Arrest Report Source Product Role Health Professional Lioresal Intrathecal(Baclofen Injection) PS Manufacturer Route Manufacturer Route Date:11/19/03ISR Number: 4239065-9Report Type:Expedited (15-DaCompany Report #2003-03851 Age:64 YR Gender: I/FU:I Outcome Dose Death 22-Aug-2005 Page: 195 PT Report Source Product Death Literature Health Professional Baclofen (Watson Laboratories) (Baclofen) Tablet Clonazepam (Watson Laboratories) (Clonazepam) Tablet Role Duration 12:15 PM PS SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/19/03ISR Number: 4246012-2Report Type:Expedited (15-DaCompany Report #20031600 Age: Gender:Male I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent INTRATHECAL Impairment/Damage PT Report Source Product Role Hepatitis Acute Foreign Health Professional Lioresal Intrathecal(Baclofen Injection) PS Manufacturer Route Manufacturer Route Date:11/21/03ISR Number: 4240662-5Report Type:Expedited (15-DaCompany Report #20031590 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Erythema Initial or Prolonged Meningitis Staphylococcal INTRATHECAL DAILY, Swelling INTRATHECAL Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Date:11/24/03ISR Number: 4239995-8Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0314709A Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 4 DAY Initial or Prolonged 5DROP Per day PT Report Source Product Role Manufacturer Route Dysaesthesia Clamoxyl PS Glaxosmithkline ORAL Hypochloraemia Laroxyl Drops SS Glaxosmithkline ORAL Hyponatraemia Lioresal SS ORAL Pyrexia Neurontin SS ORAL Rivotril Drops SS Dantrium SS Heptamyl C Diantalvic Eductyl C C 9UNIT Per day 2UNIT Per day 7DROP per day Glaxosmithkline ORAL 3UNIT Per day 3TAB Per day ORAL 2 Forlax Oroken C C Rocephine C Gentalline C Glaxosmithkline Role Manufacturer PS Watson Laboratories DAY INTRAVENOUS INTRAVENOUS Date:11/24/03ISR Number: 4241863-2Report Type:Expedited (15-DaCompany Report #2003-04000 Age:64 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Cardio-Respiratory Arrest Literature Health Professional Baclofen (Watson Laboratories)(Baclof en) Tablet Doxepin (Watson Laboratories) (Doxepin Hydrochloride) Capsule Quetiapine (Quetiapine) Duration Date:11/25/03ISR Number: 4242702-6Report Type:Expedited (15-DaCompany Report #2003117889 Age:53 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 196 12:15 PM PT Back Pain Blood Bicarbonate Abnormal Blood Uric Acid Decreased SS SS Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Dysaesthesia Heat Stroke Hypochloraemia Report Source Product Role Inappropriate Antidiuretic Hormone Foreign Health Neurontin (Gabapentin) PS ORAL Secretion Pyrexia Professional Amoxicillin Trihydrate (Amoxicillin Trihydrate) SS ORAL Heptaminol Hydrochloride (Heptaminol Hydrochloride) SS ORAL Amitriptyline Hydrochloride (Amitriptyline Hydrochloride) SS ORAL Baclofen (Baclofen) SS ORAL Dantrolene Sodium (Dantrolene Sodium) SS ORAL Manufacturer Route Duration 800 MG, ORAL ORAL 563.4 MG, ORAL ORAL 90 MG, ORAL 75 MG, ORAL Clonazepam (Clonazepam) Dextropropoxyphene (Dextropropoxyphene) Paracetamol (Paracetamol) Eductyl (Sodium Bicarbonate, Potassium Bitartrate) Macrogol (Macrogol) Cefixime (Cefixime) Ceftriaxone (Ceftriaxone) C C C C C C C Date:11/28/03ISR Number: 4244658-9Report Type:Expedited (15-DaCompany Report #FRP03000847 Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 25 MG, 3/DAY, PT Report Source Product Role Manufacturer Route Back Pain Blood Osmolarity Foreign Health Dantrium (Dantrolene Sodium)Capsule, 25mg PS ORAL Decreased Professional Blood Uric Acid Decreased Dysaesthesia Other Clamoxyl(Amoxicillin Trihydrate) SS ORAL Hept-A-Myl(Heptamino l Hydrochloride) SS ORAL Laroxyl(Amitriptylin e Hydrochloride) SS ORAL Lioresal "Ciba-Geigy"(Baclofe n) SS ORAL Neurontin(Gabapentin ) SS ORAL Rivotril(Clonazepam) SS ORAL ORAL ORAL Heat Stroke Hypochloraemia 563.4 MG, Hyponatraemia DAILY , ORAL Inappropriate Antidiuretic Hormone 5 MG, DAILY , Secretion ORAL Pyrexia Urine Sodium Abnormal 90 MG DAILY ORAL 800 MG, DAILY , ORAL 0.7 MG , DAILY ,ORAL 22-Aug-2005 Page: 197 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Di-Antalvic(Dextropr opoxyphene Hydrochloride) Eductyl(Potassium Bitartrate, Sodium Bicarbonate) Forlax(Macrogol) Oroken(Cefixime) SS SS SS SS 2 DF, DAILY, Rocephin(Ceftriaxone Sodium) SS Gentamycin-Mp(Gentam icin Sulfate) SS INJECTION NOS Date:11/28/03ISR Number: 4245376-3Report Type:Expedited (15-DaCompany Report #20031610 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Meningitis Initial or Prolonged INTRATHECAL MCG, DAILY, Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route INTRATHECAL Date:12/04/03ISR Number: 4247362-6Report Type:Expedited (15-DaCompany Report #2003AP04198 Age:35 YR Gender:Male I/FU:I Outcome PT Dose Duration Life-Threatening Coma TRANSDERMAL 900 MG DAILY Drug Level Above TD Therapeutic TRANSDERMAL 360 MG DAILY Drug Screen Positive TD Overdose TRANSDERMAL 900 MG DAILY TD Report Source Product Role Literature Lidocaine PS Amitriptyline SS Ketamine SS Health Professional TRANSDERMAL Baclofen SS Ketoprofen SS 900 MG DAILY TD TRANSDERMAL 1800 MG DAILY TD Date:12/08/03ISR Number: 4247086-5Report Type:Expedited (15-DaCompany Report #PHNU2003DE03643 Age:67 YR Gender:Female I/FU:F Outcome Dose Death Other PT Report Source Product Role Manufacturer Condition Aggravated Drug Effect Decreased Drug Ineffective Medication Error Lioresal Intrathecal PS Lioresal Intrathecal SS Novartis Sector: Pharma Novartis Sector: Pharma Muscle Spasticity Pneumonia Lioresal Intrathecal SS Novartis Sector: Pharma Product Role Manufacturer Lioresal PS Novartis Sector: Pharma Route Duration 297ng/day 297ng/day Respiratory Failure Date:12/08/03ISR Number: 4247334-1Report Type:Expedited (15-DaCompany Report #PHFR2003GB04243 Age: Gender:Male I/FU:F Outcome Dose Other 22-Aug-2005 Page: 198 PT Report Source Duration Oesophageal Rupture Peptic Ulcer 12:15 PM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/08/03ISR Number: 4248474-3Report Type:Direct Age:54 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged Disability Required Intervention to Prevent Permanent Impairment/Damage PT Company Report #CTU 207682 Report Source Coma Drug Withdrawal Syndrome Dyskinesia Fatigue Flushing Heart Rate Increased Mydriasis Pupil Fixed Somnolence Product Role Manufacturer Route Intrathecal Baclofen Pump PS Medtronic Manufacturer Route Manufacturer Route Date:12/08/03ISR Number: 4248588-8Report Type:Expedited (15-DaCompany Report #20031616 Age: Gender:Male I/FU:I Outcome PT Dose Duration Required Meningitis Intervention to INTRATHECAL UNG MCG, Prevent Permanent DAILY, Impairment/Damage INTRATHECAL Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Date:12/08/03ISR Number: 4248589-XReport Type:Expedited (15-DaCompany Report #20031620 Age: Gender:Female I/FU:I Outcome Dose Duration Required Intervention to UNK MCG, Prevent Permanent DAILY, Impairment/Damage INTRATHECAL PT Report Source Product Role Drug Withdrawal Syndrome Pruritus Health Professional Lioresal Intrathecal (Baclofen Injection) PS Pyrexia Date:12/08/03ISR Number: 4248590-6Report Type:Expedited (15-DaCompany Report #20031619 Age: Gender:Male I/FU:I Outcome Dose Death INTRATHECAL PT Report Source Product Role Breath Holding Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Duration MCG, DAILY, INTRATHECAL Date:12/08/03ISR Number: 4248591-8Report Type:Expedited (15-DaCompany Report #20031615 Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Agitation Initial or Prolonged Clonus INTRATHECAL UNK MCG, Heart Rate Increased DAILY, Muscle Spasticity INTRATHECAL Pruritus Pyrexia Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Date:12/08/03ISR Number: 4248790-5Report Type:Expedited (15-DaCompany Report #K200301829 Age:69 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 199 12:15 PM PT Blood Potassium Decreased Blood Sodium Decreased FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Chest Pain Dehydration Left Ventricular Failure Dose Report Source Product Role Manufacturer Route Foreign Health Professional Altace Capsules (Ramipril)Capsule, 5mg PS ORAL Prozac (Fluoxetine Hydrochloride) Capsule, 20 Mg SS ORAL Lioresal "Ciba-Geigy"(Baclofe n) Tablet, 10 Mg SS ORAL Lexomil (Bromazepam) Tablet, 12 Mg SS ORAL Duration Renal Failure Acute Vomiting 10 MG, QD, Other ORAL 20 MG, QD, ORAL 40 MG, QD, ORAL 9 MG, ORAL Corvasal (Molsidomine) Tablet, 4 Mg Cordarone (Amiodarone Hydrochloride) Tablet Trinipatch (Glyceryl Trinitrate) Patch, 5mg C C C Date:12/09/03ISR Number: 4249963-8Report Type:Expedited (15-DaCompany Report #20031628 Age: Gender:Male I/FU:I Outcome Dose Death INTRATHECAL PT Report Source Product Role Cardio-Respiratory Arrest Health Professional Lioresal Intrathecal (Baclofen Injection) 500mcg/Ml PS Duration DAILY, Manufacturer Route INTRATHECAL Date:12/10/03ISR Number: 4248881-9Report Type:Expedited (15-DaCompany Report #PHRM2003FR03170 Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 90 mg/day PT Report Source Product Role Manufacturer Route Back Pain Blood Bicarbonate Lioresal PS Novartis Sector: Pharma ORAL Abnormal Clamoxyl SS ORAL Blood Osmolarity Hept-A-Myl SS ORAL Decreased Laroxyl SS ORAL Blood Uric Acid Decreased Dantrium SS ORAL Body Temperature Neurontin SS ORAL Increased Rivotril SS ORAL Dysaesthesia Heat Stroke Di-Antalvic Eductyl SS SS ORAL Hypochloraemia Hyponatraemia Inappropriate Antidiuretic Hormone Secretion Pyrexia Forlax SS ORAL 5760 MIN 563.4 mg/day 5 drops/day 75 mg/day 800 mg/day 7 drops/day RECTAL 22-Aug-2005 Page: 200 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/10/03ISR Number: 4248892-3Report Type:Expedited (15-DaCompany Report #PHRM2003FR03171 Age:69 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 40 mg/day PT Report Source Product Role Manufacturer Route Blood Potassium Decreased Chest Pain Lioresal PS Novartis Sector: Pharma ORAL Dehydration Prozac Hyponatraemia Left Ventricular Failure Renal Failure Acute Triatec SS ORAL /Fra/ SS ORAL Lexomil SS ORAL Corvasal C ORAL /Net/ C ORAL Trinipatch C 20 mg/day 5 mg, BID .25 DF, TID 4 mg, TID Cordarone 200 mg, QW5 TRANSDERMAL Date:12/10/03ISR Number: 4248895-9Report Type:Expedited (15-DaCompany Report #PHRM2003FR03073 Age:11 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Chillblains Dermatitis Bullous Lioresal PS Novartis Sector: Pharma ORAL Peripheral Coldness Peripheral Vascular Disorder Raynaud'S Phenomenon Zymafluor Lubentyl Duration 20 mg/day C C ORAL ORAL Date:12/12/03ISR Number: 4251841-5Report Type:Expedited (15-DaCompany Report #KII-2003-0004887 Age:44 YR Gender:Male I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Other Blood Pressure Decreased Decubitus Ulcer Depressed Level Of Consciousness Study Health Professional Other Morphine Sulfate (Similar To Nda 19-516)(Morphine Sulfate) Unknown PS Medication Error Baclofen (Baclofen) SS Pyrexia Ambien (Zolpidem Tartrate) Benzodiazepine Derivatives ( ) ORAL 9 MG, TID, Infection ORAL SEE TEXT SS SS Date:12/16/03ISR Number: 4252351-1Report Type:Expedited (15-DaCompany Report #FR-BRISTOL-MYERS SQUIBB COMPANY-12455887 Age:76 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Dermatitis Bullous Drug Interaction Pemphigoid Health Professional Lopril PS Geneva Pharmaceuticals, Inc. (Novartis) ORAL Treated 2-3 Pruritus years Loxen SS ORAL Lioresal I ORAL Seropram I ORAL Asasantine I ORAL Treated for 2-3 years 0.5 tab per day (0,5 DOSE X 3/D) Treated for 2-3 years Treated for 22-Aug-2005 Page: 201 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 2-3 years Date:12/16/03ISR Number: 4252700-4Report Type:Expedited (15-DaCompany Report #03-12-1548 Age:62 YR Gender:Female I/FU:I Outcome Dose Disability 12.5MG BID PT Report Source Product Role Manufacturer Route Muscle Twitching Foreign Baclofen PS Ipi ORAL Muscular Weakness Literature Propofol SS Sufentanil SS Isoflurane Inhalation Solution SS Manufacturer Route Duration ORAL Health 2.5MG/KG/HOUR Professional (S) Other 0.25UG/KG HOUR(S) 0.6-1.0 VOL% Diazepam Levothyroxine Vitamin B 12 Injectable Atracurium Cefuroxime Clindamycin Dexamethasone Morphine Prednisone C C C C C C C C C Date:12/17/03ISR Number: 4254524-0Report Type:Expedited (15-DaCompany Report #20031618 Age: Gender:Male I/FU:F Outcome PT Dose Duration Required Hyperaemia Intervention to Hypotension Prevent Permanent Rash Erythematous Impairment/Damage Respiratory Rate INTRATHECAL 100 MCG, Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection), 500mcg/Ml PS Decreased DAILY, Somnolence INTRATHECAL Tachycardia Date:12/17/03ISR Number: 4254528-8Report Type:Expedited (15-DaCompany Report #20031620 Age: Gender:Female I/FU:F Outcome Dose Duration Required Intervention to INTRATHECAL DAILY, Prevent Permanent INTRATHECAL Impairment/Damage PT Report Source Product Role Erythema Meningitis Staphylococcal Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Pruritus Swelling Date:12/17/03ISR Number: 4254987-0Report Type:Expedited (15-DaCompany Report #ZANA001112 Age:32 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Other 36 MG ORAL PT Report Source Product Role Drug Interaction Haemolysis Health Professional Zanaflex (Tizanidine Hydrochloride) PS Baclofen (Baclofen) Neurontin (Gabapentin) Ditropan (Oxybutynin) Prednisone 22-Aug-2005 Page: 202 12:15 PM SS C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Prednisone) Date:12/17/03ISR Number: 4271963-2Report Type:Periodic Age:19 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Company Report #USA-2003-0009873 PT Report Source Product Role Coma Loss Of Consciousness Overdose Consumer Other Oxycontin Tablets (Oxycodone Hydrochloride) Celebrex (Celecoxib) Baclofen (Baclofen) Ghb (Oxybate Sodium) PS SS SS SS Date:12/17/03ISR Number: 4271964-4Report Type:Periodic Age:18 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged C Manufacturer Route Manufacturer Route Manufacturer Route Company Report #USA-2003-0009874 PT Report Source Product Role Loss Of Consciousness Overdose Consumer Other Oxycontin Tablets (Oxycodone Hydrochloride) Celebrex (Celecoxib) Baclofen (Baclofen) Ghb (Oxybate Sodium) PS SS SS SS Date:12/18/03ISR Number: 4255375-3Report Type:Expedited (15-DaCompany Report #230032K03FRA Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Feeling Drunk Initial or Prolonged Malaise SUBCUTANEOUS 44 MCG, 3 IN Syncope 1 WEEKS, Report Source Product Role Foreign Consumer Rebif (Interferon Beta) PS Baclofen SS Health Professional SUBCUTANEOUS 2 DOSAGE FORMS, 3 IN 1 2 YR ORAL DAYS, PER ORAL Vasobral SS ORAL Modafinil SS ORAL Zopiclone SS Mianserin SS Fenofibrate SS Oxybutynin SS Dantrolene Sodium SS 1 DOSAGE FORMS, 3 IN 1 DAYS, PER ORAL 3 DOSAGE FORMS, 3 IN 1 DAYS, PER ORAL 0.5 NOT REPORTED, 1 IN 1 DAYS, NOT REPORTED NOT REPORTED, 1 IN 1 DAYS, NOT REPORTED NOT REPORTED, 1 IN 1 DAYS, NOT REPORTED NOT REPORTED, 2 IN 1 DAYS, NOT REPORTED NOT REPORTED, 3 IN 1 DAYS, 22-Aug-2005 Page: 203 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report NOT REPORTED Date:12/18/03ISR Number: 4255551-XReport Type:Expedited (15-DaCompany Report #2003117889 Age:53 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 800 MG, ORAL PT Report Source Product Role Manufacturer Route Back Pain Blood Osmolarity Foreign Health Neurontin (Gabapentin) PS ORAL Decreased Blood Uric Acid Decreased Dysaesthesia Heat Stroke Professional Amoxicillin Trihydrate (Amoxicillin Trihydrate) SS ORAL Hypochloraemia Hyponatraemia Inappropriate Antidiuretic Hormone Amitriptyline Hydrochloride (Amitriptyline Hydrochloride) SS ORAL Secretion Pyrexia Dantrolene Sodium (Dantrolene Sodium) SS ORAL Baclofen (Baclofen) SS ORAL Heptaminol Hydrochloride (Heptaminol Hydrochloride) C ORAL ORAL ORAL 75 MG, ORAL 90 MG, ORAL 563.4 MG, ORAL Clonazepam (Clonazepam ) Dextropropoxyphene (Dextropropoxyphene) Paracetamol (Paracetamol) Eductyl (Sodium Bicarbonate, Potassium Bitartrate) Macrogol (Macrogol) Cefixime (Cefixime) Ceftriaxone C C C C C C (Ceftriaxone) Gentamicin (Gentamicin) C C Date:12/19/03ISR Number: 4255498-9Report Type:Expedited (15-DaCompany Report #99F--10645 Age: Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Aggression Agitation Confusional State Electroencephalogram Abnormal Encephalopathy Muscle Rigidity Report Source Product Role Lioresal Pirilene Rimifon Rifampicin Mopral Fozitec Hemodialysis PS C C C C C C UNKNOWN Date:12/19/03ISR Number: 4255933-6Report Type:Direct Age:17 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization 22-Aug-2005 Page: 204 12:15 PM Company Report #CTU 208449 Manufacturer Route ORAL ORAL ORAL ORAL ORAL ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Initial or Prolonged PT Dose Report Source Product Role Baclofen-Intrathecal 4000.0 Ug/Ml PS Manufacturer Route Manufacturer Route Manufacturer Route Duration Accident Catheter Related 40.6 UG/HR Complication INTRATHECAL 975.0 UG/D IT Device Failure Drug Withdrawal Syndrome Medication Error Overdose Respiratory Arrest Date:12/22/03ISR Number: 4257661-XReport Type:Expedited (15-DaCompany Report #20031642 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged MCG, DAILY, PT Report Source Product Role Diplegia Overdose Health Professional Lioresal Intrathecal (Baclofen Injection) PS Therapeutic Response INTRATHECAL Decreased Urinary Incontinence Date:12/22/03ISR Number: 4257663-3Report Type:Expedited (15-DaCompany Report #20031525 Age: Gender:Female I/FU:F Outcome Dose Death INTRATHECAL PT Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Duration Bronchopneumonia Cerebral Palsy MCG, DAILY, Muscle Spasticity INTRATHECAL Panic Reaction Date:12/23/03ISR Number: 4257952-2Report Type:Expedited (15-DaCompany Report #S03-FRA-05163-01 Age:76 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Dermatitis Bullous Pemphigoid Pruritus Foreign Health Professional Other Seropram (Citalopram Hydrobromide) Lopril (Captoprol) Lioresal "Novartis" (Baclofen) Role Manufacturer Route "Novartis" ORAL Route PS SS SS 0.5 UNK TID PO Loxen (Nicardipine Hydrochloride) Dipyridamole SS SS Date:12/24/03ISR Number: 4257446-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB04829 Age: Gender:Male I/FU:I Outcome Dose Other PT Psychotic Disorder UNKNOWN 22-Aug-2005 Page: 205 Report Source Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Duration 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/24/03ISR Number: 4257792-4Report Type:Expedited (15-DaCompany Report #PHRM2003FR03355 Age:76 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 5 mg, TID PT Report Source Pemphigoid Pruritus Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Loxen/Cardene Lopril Seropram Asasantin SS SS SS SS ORAL ORAL ORAL ORAL Date:01/02/04ISR Number: 4263784-1Report Type:Expedited (15-DaCompany Report #ZANA001112 Age:32 YR Gender:Male I/FU:F Outcome Dose Duration Life-Threatening Other 36 MG ORAL PT Report Source Product Role Glucose-6-Phosphate Dehydrogenase Deficiency Health Professional Zanaflex (Tizanidine Hydrochloride) PS Haemolysis Refusal Of Treatment By Patient Baclofen (Baclofen) Neurontin (Gabapentin) Ditropan (Oxybutynin) Predenisone (Prednisone) Manufacturer Route ORAL SS C C C Date:01/06/04ISR Number: 4263864-0Report Type:Expedited (15-DaCompany Report #PHBS2003CH14515 Age:76 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 20 mg/day 2880 MIN Other UNKNOWN PT Report Source Product Role Manufacturer Route Coma Fall Lioresal PS Novartis Sector: Pharma ORAL Somnolence 1440 MIN Stupor Temesta SS Floxapen C INTRAVENOUS DRIP 6 g Insulin C Actrapid C Benerva C UNKNOWN UNKNOWN UNKNOWN Date:01/06/04ISR Number: 4264762-9Report Type:Expedited (15-DaCompany Report #PHNU2003DE02970 Age:15 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Alanine Aminotransferase Increased Health Professional Lioresal PS Novartis Sector: Pharma ORAL Novartis Sector: Pharma ORAL Duration UNK Aspartate Aminotransferase Lioresal 50mg/day Increased Gamma-Glutamyltransferase Increased Date:01/06/04ISR Number: 4266163-6Report Type:Expedited (15-DaCompany Report #KII-2003-0006601 Age:63 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 206 12:15 PM PT Disorientation Drug Interaction Mental Status Changes Pain SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Rate Decreased Sinus Tachycardia Dose Report Source Product Study Health Professional Other Oxycodone Hydrochloride Fentanyl (Fentanyl) Amitriptyline (Amitriptyline) Ssri ( ) Baclofen (Baclofen) Gabapentin (Gabapentin) Tramadol (Tramadol) Cr Tablet Tolterodine (Tolterodine) Role Manufacturer Route Manufacturer Route Duration Somnolence PS SS SS SS SS SS SS SS Date:01/07/04ISR Number: 4265026-XReport Type:Expedited (15-DaCompany Report #99F--10645 Age: Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Aggression Agitation Confusional State Electroencephalogram Abnormal Encephalopathy Muscle Rigidity Product Role Lioresal Pirilene Rimifon Rifampicin Mopral Fozitec Hemodialysis PS C C C C C C ORAL ORAL ORAL ORAL ORAL ORAL UNKNOWN Date:01/07/04ISR Number: 4265753-4Report Type:Expedited (15-DaCompany Report #FR-ROCHE-354811 Age:76 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Pemphigoid Consumer Loxen Lp Lioresal Lopril Seropram Asasantin PS SS SS SS SS Roche ORAL ORAL ORAL ORAL ORAL Date:01/07/04ISR Number: 4267133-4Report Type:Expedited (15-DaCompany Report #20031649 Age: Gender:Female I/FU:I Outcome Dose Death INTRATHECAL PT Report Source Product Role Foreign Health Professional Lioresal Intrathecal (Baclofen Injection)2000 Mcg/Ml PS Antibiotics Dexamethasone C C Duration Coma Dyspnoea Hypertonia Hypotonia MCG, DAILY, Medical Device INTRATHECAL Complication Medical Device Implantation Proteus Infection Urosepsis 22-Aug-2005 Page: 207 12:15 PM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/07/04ISR Number: 4267152-8Report Type:Expedited (15-DaCompany Report #US-SHR-03-019043 Age:62 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SUBCUTANEOUS PT Report Source Product Role Coma Injection Site Cellulitis Pyrexia Consumer Betaseron(Interferon Beta-1b) Betaseron(Interferon Beta -1b) Injection, 250ug PS Baclofen (Baclofen) SS Manufacturer Route Manufacturer Route Manufacturer Route 8 MIU, EVERY 2 D, HS, SUBCUTANEOUS Date:01/13/04ISR Number: 4270791-1Report Type:Expedited (15-DaCompany Report #20041663 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Abdominal Distension Initial or Prolonged Agitation INTRATHECAL DAILY, Anorexia INTRATHECAL Constipation Drug Withdrawal Syndrome Pyrexia Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Date:01/13/04ISR Number: 4271325-8Report Type:Expedited (15-DaCompany Report #20031610 Age: Gender:Male I/FU:F Outcome PT Dose Duration Hospitalization Csf Culture Positive Initial or Prolonged Implant Site Infection INTRATHECAL DAILY, Meningitis INTRATHECAL Staphylococcal Infection Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Date:01/13/04ISR Number: 4271333-7Report Type:Expedited (15-DaCompany Report #20031616 Age: Gender:Male I/FU:F Outcome Dose Duration Required Intervention to Prevent Permanent INTRATHECAL DAILY, Impairment/Damage INTRATHECAL PT Report Source Product Role Csf Bacteria Identified Implant Site Infection Meningitis Health Professional Lioresal Intrathecal(Baclofen Injection) PS Antibiotics C Manufacturer Route Staphylococcal Infection Date:01/14/04ISR Number: 4269940-0Report Type:Expedited (15-DaCompany Report #PHNU2003DE02970 Age:15 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Alanine Aminotransferase Increased Health Professional Lioresal PS Novartis Sector: Pharma ORAL Duration 10 mg, 5QD Aspartate Aminotransferase Increased Epstein-Barr Virus Antibody Positive Gamma-Glutamyltransferase Increased 22-Aug-2005 Page: 208 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/16/04ISR Number: 4275090-XReport Type:Expedited (15-DaCompany Report #2004001460 Age:37 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG (TID) PT Report Source Product Role Condition Aggravated Neutropenia Foreign Health Triflucan (Fluconazole) PS Normochromic Normocytic Professional Baclofen (Baclofen) SS Manufacturer Route ORAL ORAL Anaemia Septic Shock White Blood Cell Count Decreased Date:01/16/04ISR Number: 4275310-1Report Type:Expedited (15-DaCompany Report #KII-2003-0006846 Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Confusional State Drug Withdrawal Syndrome Flushing Hyperhidrosis Hypertension Study Health Professional Other Oxycodone Hydrochloride (Similar To Nda 20-553)(Oxycodone Hydrochloride) PS ORAL Morphine Sulfate (Similar No Nda19-516) (Morphine Sulfate) Unknown SS ORAL Baclofen (Baclofen) SS ORAL ORAL Mental Status Changes Overdose Somnolence Tachycardia ORAL ORAL Neurontin (Gabapentin) Zinc (Zinc) Hydrochlorothiazide (Hydrochlorothiazide ) Tablet Paxil ((Paroxetine Hydrochloride) Vitamin A (Retinol) Vitamin C (Ascorbic Acid) SS SS SS SS SS C Date:01/20/04ISR Number: 4274648-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB00566 Age:4 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 6 mg, QID PT Report Source Bradycardia Hypothermia Product Role Manufacturer Route Baclofen PS Novartis Sector: Pharma ORAL Melatonin C ORAL 6m/day Date:01/20/04ISR Number: 4281437-0Report Type:Periodic Age:17 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL 22-Aug-2005 Page: 209 PT Report Source Product Role Hypertonia Health Professional Lioresal Intrathecal $Me(Baclofen) Ampoule PS INTRATHECAL 12:15 PM Company Report #PHBS2003US10785 Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/04ISR Number: 4277663-7Report Type:Expedited (15-DaCompany Report #20041668 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Hypotension Initial or Prolonged Hypothermia INTRATHECAL UNK MCG, Hypotonia DAILY, Medical Device Pain INTRATHECAL Mental Status Changes Shock Report Source Product Role Health Professional Lioresal Intrathecal (Vaclofen Injection) PS Manufacturer Route Date:01/22/04ISR Number: 4277500-0Report Type:Expedited (15-DaCompany Report #99F--10373 Age:65 YR Gender:Male I/FU:F Outcome PT Dose Duration Hospitalization Agitation Initial or Prolonged Blood Bicarbonate 5 mg, QD 8640 MIN Increased 3 Blood Creatinine Abnormal courses/week Blood Glucose Increased Blood Urea Increased 900 mg/day Coma Confusional State Encephalopathy Haemoglobin Decreased 750 mg/day Muscle Rigidity 40 mg/day Personality Change Due To 0.5 tab/day A General Medical Condition Toxic Induced Encephalopathy Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Hemodialysis C Rimifon Rifampicin C C ORAL ORAL Inh Triatec Amlor Pirilene C C C C ORAL ORAL ORAL ORAL Mopral C ORAL Fozitec C ORAL Date:01/23/04ISR Number: 4279366-1Report Type:Expedited (15-DaCompany Report #230032K03FRA Age: Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged SUBCUTANEOUS 44 MCG PT Report Source Product Role Manufacturer Route Feeling Drunk Malaise 3 IN 1 Syncope Foreign Consumer Rebif (Interferon Beta) PS Baclofen SS ORAL Vasobral SS ORAL Modafinil SS ORAL Zopiclone SS Mianserin SS Fenofibrate SS Health WEEKS Professional SUBCUTANEOUS 2 YR 2 DOSAGE FORMS, 3 IN 1 DAYS, PER ORAL 1 DOSAGE FORMS, 3 IN 1 DAYS, PER ORAL 3 DOSAGE FORMS, 3 IN 1 DAYS, PER ORAL 0.5 NOT REPORTED, 1 IN 1 DAYS, NOT REPORTED NOT REPORTED, 1 IN 1 DAYS NOT REPORTED NOT REPORTED 22-Aug-2005 Page: 210 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report 1 IN 1 DAYS, NOT REPORTED Oxybutynin SS Dantrolene Sodium SS NOT REPORTED, 2 IN 1 DAYS, NOT REPORTED NOT REPORTED, 3 IN 1 DAYS, NOT REPORTED Date:01/23/04ISR Number: 4279515-5Report Type:Expedited (15-DaCompany Report #DSA_23795_2004 Age:76 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 10 MG BID PO Other PT Report Source Product Role Coma Drug Interaction Foreign Health Temesta Lioresal PS SS Fall Somnolence Professional Other Floxapen Insulatard Actrapid Human Benerva C C C C Manufacturer Route ORAL Date:01/30/04ISR Number: 4281985-3Report Type:Expedited (15-DaCompany Report #PHBS2004CA01117 Age:27 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Agitation Anger Lioresal PS Novartis Sector: Pharma ORAL Antisocial Behaviour Constipation Lioresal Novartis Sector: Pharma ORAL Depression Dry Mouth Lioresal Novartis Sector: Pharma ORAL Duration 1 tablet/day 1 tablet, BID 1 tablet, TID 4320 MIN SS 4320 MIN 4320 MIN SS Dysphagia Eye Disorder Lioresal SS Novartis Sector: Pharma ORAL Novartis Sector: Pharma ORAL Novartis Sector: Pharma ORAL Manufacturer Route 2 tablets, Hallucination BID 4320 MIN Hyperhidrosis Insomnia Lioresal SS 2 tablets, Lethargy TID 1 tablet/day 2880 MIN Mood Swings Paranoia Lioresal Thyroid Function Test Domperidone SS 5760 MIN C UNKNOWN Abnormal Urine Output Decreased Date:02/03/04ISR Number: 4285825-8Report Type:Expedited (15-DaCompany Report #KII-2003-0007030 Age:51 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other ORAL ORAL 22-Aug-2005 Page: 211 12:15 PM PT Report Source Product Role Coma Convulsion Medication Error Study Health Professional Ms Contin Tablets (Morphine Sulfate) Cr Tablet PS ORAL Muscle Spasms Overdose Sleep Apnoea Syndrome Other Oxycodone Hydrochloride (Similar To Nda 20-553) (Oxycodone Hydrocloride) Baclofen (Baclofen) SS SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/04/04ISR Number: 4284881-0Report Type:Expedited (15-DaCompany Report #PHRM2004FR00643 Age:37 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 87840MIN 400 mg, TID PT Report Source Product Role Manufacturer Route Anaemia Coma Lioresal PS Novartis Sector: Pharma ORAL Neutropenia Triflucan SS ORAL 57600MIN Septic Shock Date:02/04/04ISR Number: 4284882-2Report Type:Expedited (15-DaCompany Report #PHFR2003GB04829 Age:41 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Delusion Hallucination, Auditory Baclofen PS Novartis Sector: Pharma ORAL Hallucination, Visual Risperidone C ORAL Psychotic Disorder Bendrofluazide C ORAL Perindopril C ORAL Metformin C Rosiglitazone C Diazepam C Duration 10 mg, QID 4 mg, QD 2.5 mg, QD 8 mg, QD 1 g, BID ORAL 4 mg mane 5 mg, TID Date:02/05/04ISR Number: 4288479-XReport Type:Expedited (15-DaCompany Report #20041682 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL PT Escherichia Infection Implant Site Infection Medical Device MCG, DAILY, Report Source Product Role Health Professional Lioresal Intrathecal(Baclofen Injection) PS Manufacturer Route Complication INTRATHECAL Meningitis Post Procedural Complication Pseudomonas Infection Date:02/09/04ISR Number: 4289929-5Report Type:Expedited (15-DaCompany Report #PHBS2004BR01170 Age:73 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Hyperaemia Hypersensitivity Lioresal PS Novartis Sector: Pharma ORAL Skin Exfoliation 50 mg/day Higroton C UNKNOWN Foraseq C UNKNOWN 200 ug/day Puran T4 C UNKNOWN 50 ug/day Marax C Manufacturer Route Duration 10 mg, BID UNKNOWN Date:02/09/04ISR Number: 4290279-1Report Type:Expedited (15-DaCompany Report #20041678 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Bacterial Infection Initial or Prolonged Implant Site Infection INTRATHECAL UNK MCG, DAILY, INTRATHECAL 22-Aug-2005 Page: 212 12:15 PM Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/04ISR Number: 4290283-3Report Type:Expedited (15-DaCompany Report #20031631 Age: Gender:Male I/FU:F Outcome PT Dose Duration Required Disease Recurrence Intervention to Fall Prevent Permanent Muscle Spasticity INTRATHECAL UNK MCG, Impairment/Damage Red Blood Cells Csf DAILY, Positive INTRATHECAL Reflexes Abnormal Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) 500mcg/Ml PS Manufacturer Route Manufacturer Route Route Date:02/10/04ISR Number: 4293965-2Report Type:Expedited (15-DaCompany Report #20041689 Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Cardio-Respiratory Arrest Initial or Prolonged Catheter Related INTRATHECAL DAILY, Complication INTRATHECAL Muscle Spasticity Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Date:02/18/04ISR Number: 4297296-6Report Type:Expedited (15-DaCompany Report #200410574FR Age:79 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SUBCUTANEOUS PT Eczema Report Source Product Role Manufacturer Lovenox PS Aventis Pharmaceuticals Inc. Tegretol - Slow Release Prozac 20 Mg Mopral Lioresal Fludex 1.5 Mg Comprime Enrobe Lp Praxilene SS SS SS SS ORAL ORAL ORAL ORAL SS C ORAL Motilium Diffu K Forlax C C C ORAL ORAL Date:02/18/04ISR Number: 4300236-4Report Type:Expedited (15-DaCompany Report #20041704 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Device Failure Initial or Prolonged Respiratory Failure Required Upper Respiratory Tract INTRATRACHEAL MCG, DAILY, Intervention to Infection INTRATHECAL Prevent Permanent Impairment/Damage Report Source Product Role Health Professional Lioresal Inthrathecal (Baclofen Injection) PS Iv Valium And Ativan C Manufacturer Route Route Date:02/19/04ISR Number: 4299078-8Report Type:Expedited (15-DaCompany Report #200412064GDDC Age:79 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged SUBCUTANEOUS 22-Aug-2005 Page: 213 PT Eczema Report Source Product Role Manufacturer Fludex PS Lovenox SS Aventis Pharmaceuticals Inc. Aventis Pharmaceuticals Inc. Prozac SS ORAL dose: UNK 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Tegretol SS ORAL Mopral SS ORAL Lioresal Praxilene Motilium Diffu K Forlax Xyzal SS C C C C C dose: 2 DF dose: UNK Date:02/20/04ISR Number: 4301283-9Report Type:Direct Age:83 YR Gender:Female I/FU:I Outcome Dose Disability 5 MG PO TID PT Company Report #CTU 212728 Report Source Product Role Aphasia Baclofen PS Asthenia Depressed Level Of Consciousness Lethargy Mutism Amlodipine Buffered Aspirin Calcium /Vit D Clonazepam Clopidogrel Cyanocobalamin Enoxaparin Escitalopram Furosemide .. Gabapentin Hydrochlorothiazide Levothyroxine Multivitamin Nystatin Simvastatin Vitamin E Acetaminophen Diphenhydramine Insulin Lispro (Sliding Scale) C C C C C C C C C C C C C C C C C C C Manufacturer Route Duration Date:02/24/04ISR Number: 4303806-2Report Type:Expedited (15-DaCompany Report #04-02-0268 Age:55 YR Gender:Male I/FU:I C ORAL Outcome Dose Duration Life-Threatening Other 80 MG ORAL PT Report Source Product Role Bradycardia Dizziness Foreign Other Baclofen - Ipi Tablets PS Gabapentin Movicol Salbutamol Vitamin C C C C C Date:02/25/04ISR Number: 4304275-9Report Type:Expedited (15-DaCompany Report #20041668 Age: Gender:Male I/FU:F Outcome Death Hospitalization Initial or Prolonged 22-Aug-2005 Page: 214 12:15 PM PT Epistaxis Hypotension Hypothermia Hypotonia Implant Site Reaction Mental Status Changes Mouth Haemorrhage Manufacturer Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pain Shock Dose Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Duration INTRATHECAL DAILY, INTRATHECAL Date:02/25/04ISR Number: 4304452-7Report Type:Expedited (15-DaCompany Report #04-02-0271 Age:40 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Psychotic Disorder Foreign Other Baclofen Tablets Ipi PS Ipi ORAL Risperidone Bendrofluazide Perindopril Metformin Rosiglitazone Diazepam C C C C C C Manufacturer Route Duration 10MG QID ORAL Date:02/25/04ISR Number: 4307179-0Report Type:Expedited (15-DaCompany Report #PHRM2004FR00853 Age:50 YR Gender:Male I/FU:I Outcome Dose INTRATHECAL PT Report Source Product Role Headache Hyperhidrosis Foreign Health Lioresal (Baclofen) PS Hypotension Professional Ileus Paralytic Urinary Retention Other Duration 50 UG, ONCE/SINGLE Date:03/02/04ISR Number: 4309428-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB01101 Age:55 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Other 80mg/day PT Bradycardia Dizziness Report Source Product Role Manufacturer Route Baclofen PS Novartis Sector: Pharma ORAL Gabapentin C ORAL Movicol C ORAL Salbutamol C Vitamin C C 300mg/day 1 sachet/day 2.5ml/day 500mg/day Date:03/02/04ISR Number: 4311023-5Report Type:Expedited (15-DaCompany Report #KII-2003-0007440 Age:41 YR Gender:Female I/FU:I Outcome Life-Threatening Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 215 12:15 PM PT Arrhythmia Blood Bicarbonate Decreased Blood Calcium Decreased Blood Glucose Increased Blood Potassium Decreased Body Temperature Increased Depressed Level Of Consciousness Drug Screen Positive Electrocardiogram Qt ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Corrected Interval Prolonged Nausea Prothrombin Time Report Source Product Role Prolonged Red Blood Cell Sedimentation Rate Increased Study Health Professional Other Morphine Sulfate (Similar To Nda 19-516) (Morphine Sulfate) PS Manufacturer Route Duration ORAL Respiratory Arrest Syncope Torsade De Pointes Ventricular Extrasystoles Ventricular Tachycardia Vomiting White Blood Cell Count Increased Vistaril(Hydroxyzine Embonate) Benadryl (Diphenhydramine Hydrochloride) Metformin (Metformin) Lipitor (Atorvastatin) Effexor (Venlafaxine Hydrochloride) Lasix (Furosemide) Potassium (Potassium) Reglan (Metoclopramide) Amfetamine (Amfetamine) Ambien (Zolpidem Tartrate) Acebutolol Hydrochloride (Acebutolol Hydrochloride) Baclofen (Baclofen) Nexium (Esomeprazole) Prilosec (Omeprazole) Quinine (Quinine) Promethazine (Promethazine) Klonopin (Clonazepam) Wellbutrin (Amfebutamone Hydrochloride) Celexa (Citalopram SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS SS ORAL Hydrobromide) C Date:03/02/04ISR Number: 4311152-6Report Type:Expedited (15-DaCompany Report #20041727 Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Drug Withdrawal Syndrome Initial or Prolonged Migration Of Implant INTRATHECAL MCG, DAILY, Required Muscle Rigidity INTRATHECAL Intervention to Muscle Spasticity Prevent Permanent Pruritus Impairment/Damage Pyrexia 22-Aug-2005 Page: 216 12:15 PM Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Baclofen C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/04ISR Number: 4312143-1Report Type:Expedited (15-DaCompany Report #20041729 Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Drug Withdrawal Syndrome Initial or Prolonged Muscle Spasticity INTRATHECAL MCG, DAILY, Pyrexia INTRATHECAL Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Route Date:03/04/04ISR Number: 4310967-8Report Type:Expedited (15-DaCompany Report #200410574FR Age:79 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged SUBCUTANEOUS PT Report Source Eczema Psoriasis Product Role Manufacturer Lovenox PS Aventis Pharmaceuticals Inc. Tegretol - Slow Release Prozac 20 Mg Mopral Lioresal Fludex 1.5 Mg Comprime Enrobe Lp Praxilene Motilium Diffu K Forlax SS SS SS SS ORAL ORAL ORAL ORAL SS C C C C ORAL ORAL ORAL Date:03/04/04ISR Number: 4311492-0Report Type:Expedited (15-DaCompany Report #PHBS2004TW02803 Age:58 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Depressed Level Of Initial or Prolonged Consciousness UNKNOWN 5 mg, TID Toxic Induced Encephalopathy Report Source Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Route Date:03/04/04ISR Number: 4311515-9Report Type:Expedited (15-DaCompany Report #PHBS2004TW02804 Age:76 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged UNKNOWN 10 mg, PT Report Source Depressed Level Of Consciousness TID Neurotoxicity Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Triazolam C Route Date:03/04/04ISR Number: 4311516-0Report Type:Expedited (15-DaCompany Report #PHBS2004TW02802 Age:50 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Agitation Initial or Prolonged Blood Glucose Increased UNKNOWN 5 mg, QID Confusional State UNKNOWN 0.25 mg/day Haemoglobin Decreased Toxic Induced Encephalopathy 22-Aug-2005 Page: 217 12:15 PM Report Source Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/10/04ISR Number: 4314817-5Report Type:Expedited (15-DaCompany Report #PHRM2004FR01023 Age:79 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Eczema Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma Tegretol Lp Fludex SS SS ORAL ORAL ORAL Mopral SS ORAL Lovenox SS Prozac SS ORAL Praxilene Motilium Diffu K Forlax Xyzall SS SS SS SS SS ORAL ORAL ORAL ORAL ORAL 1.5 mg/day 20 mg/day SUBCUTANEOUS 20 mg/day Date:03/11/04ISR Number: 4316454-5Report Type:Expedited (15-DaCompany Report #PHNU2003DE04094 Age: Gender:Male I/FU:F Outcome Dose Death INTRATHECAL PT Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen) PS Manufacturer Route Manufacturer Route Duration Device Failure Drug Ineffective SEE IMAGE, Drug Level Fluctuating Other INTRATHECAL Drug Withdrawal Syndrome Electroencephalogram Abnormal Muscle Spasticity Sudden Death Date:03/12/04ISR Number: 4316048-1Report Type:Expedited (15-DaCompany Report #PHBS2004CA03144 Age: Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Life-Threatening Hospitalization INTRATHECAL 530 Initial or Prolonged INTRATHECAL Cheyne-Stokes Respiration Respiratory Rate Lioresal Inthratecal PS Novartis Sector: Pharma Decreased Lioresal Inthratecal SS Novartis Sector: Pharma Lioresal Clonazepam SS C Depakene C 585 ORAL UNKNOWN UNKNOWN Date:03/17/04ISR Number: 4320217-4Report Type:Expedited (15-DaCompany Report #ZANA001136 Age:24 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 12 MG DAILY PT Report Source Product Role Manufacturer Route Bradycardia Drug Interaction Foreign Health Sirdalud (Tizanidine Hydrochloride) PS ORAL Hypotension Professional Hypotonia Other Lioresal (Baclofen) SS ORAL Myolastan (Tetrazepam) SS ORAL Ciflox (Ciprofloxacin) SS Voltarene Lp (Diclofenac Sodium) C ORAL 30 MG DAILY Malaise ORAL Skin Infection 75 MG DAILY ORAL 1 G DAILY 22-Aug-2005 Page: 218 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/19/04ISR Number: 4319830-XReport Type:Expedited (15-DaCompany Report #PHRM2004FR01091 Age:19 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Anorexia Initial or Prolonged General Physical Health 15 mg, TID 15840MIN Deterioration Hypernatraemia Muscle Spasticity Somnolence Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Manufacturer Route Manufacturer Route Date:03/19/04ISR Number: 4321930-5Report Type:Expedited (15-DaCompany Report #20041729 Age: Gender:Female I/FU:F Outcome PT Dose Duration Hospitalization Drug Withdrawal Syndrome Initial or Prolonged Muscle Spasticity INTRATHECAL MCG, DAILY, Pyrexia INTRATHECAL Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Date:03/19/04ISR Number: 4322351-1Report Type:Expedited (15-DaCompany Report #ZANA001136 Age:24 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 12 MG DAILY PT Report Source Product Role Bradycardia Drug Interaction Foreign Health Sirdalud (Tizanidine Hydrochloride) PS ORAL Hypotension Professional Hypotonia Other Lioresal (Baclofen) SS ORAL Myolastan (Tetrazepam) SS ORAL ORAL 30 MG DAILY Malaise ORAL 75 MG DAILY ORAL Ciflox (Ciprofloxacin) SS Voltaren Lp Diclofenac Sodium) C 1 G DAILY Date:03/22/04ISR Number: 4321082-1Report Type:Direct Age:55 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 5 MG BID PRN PT Company Report #CTU 214876 Report Source Product Role Confusional State Fatigue Baclofen 10mg Tablets PS Mental Status Changes Somnolence Paracalitol Epoetin Ferrous Gluconate Allopurinol Warfarin Nephrovite Metoprolol Oxycodone/Apap C C C C C C C C Date:03/23/04ISR Number: 4324819-0Report Type:Expedited (15-DaCompany Report #2004-01007 Age:62 YR Gender:Female I/FU:I Outcome Other 22-Aug-2005 Page: 219 PT Anaesthetic Complication Drug Interaction Hypotonia 12:15 PM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Muscular Weakness Dose Report Source Product Role Manufacturer Route Foreign Literature Health Baclofen (Watson Laboratories) (Baclofen) Tablet PS Watson Laboratories ORAL Isoflurane (Isoflurane) SS Duration 12.5 MG, BID, Professional ORAL Other OTHER 0.6 TO 1.0 VOL%, OTHER Prednisone Diazepam Levothyroxine (Levothyroxine) Vitamin B12 Injection Propofol (Propofol) Sufentanil (Sufentanil) Cefuroxime (Cefuroxime) Clindamycin (Clindamycin) Dexamethasone Atracurium (Atracurium) Morphine (Morphine) C C C C C C C C C C C Date:03/24/04ISR Number: 4325382-0Report Type:Expedited (15-DaCompany Report #20031619 Age: Gender:Male I/FU:F Outcome Dose Death INTRATHECAL INTRATHECAL PT Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Duration Breath Holding Cardiac Disorder MCG, DAILY, Manufacturer Route Date:03/26/04ISR Number: 4323641-9Report Type:Expedited (15-DaCompany Report #PHNU2004DE01249 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged UNKNOWN PT Report Source Abdominal Pain Acidosis Product Role Manufacturer Lioresal PS Novartis Sector: Pharma Manufacturer Route Blood Ph Decreased Hypokalaemia Hyponatraemia Respiratory Failure Somnolence Date:03/29/04ISR Number: 4330481-3Report Type:Expedited (15-DaCompany Report #20031600 Age: Gender: I/FU:F Outcome Dose Duration Required Intervention to INTRATHECAL MCG, Prevent Permanent INTRATHECAL Impairment/Damage 22-Aug-2005 Page: 220 12:15 PM PT Report Source Product Role Hepatitis Foreign Health Lioresal Intrathecal (Baclofen Injection) PS DAILY, Professional Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/29/04ISR Number: 4330679-4Report Type:Expedited (15-DaCompany Report #PHFR2003GB04316 Age: Gender:Male I/FU:F Outcome Dose INTRATHECAL PT Report Source Product Role Health Professional Baclofen Intrathecal (Baclofen) Unknown PS Manufacturer Route Manufacturer Route Manufacturer Route Duration Cholelithiasis Hepatitis Acute INTRATHECAL Other Date:03/29/04ISR Number: 4332202-7Report Type:Expedited (15-DaCompany Report #20041748 Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Cerebrospinal Fluid Initial or Prolonged Leakage INTRATHECAL DAILY, Headache INTRATHECAL Lymphoedema Meningitis Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Date:03/30/04ISR Number: 4332873-5Report Type:Expedited (15-DaCompany Report #20041727 Age: Gender:Female I/FU:F Outcome PT Dose Duration Hospitalization Drug Withdrawal Syndrome Initial or Prolonged Pocket Erosion INTRATHECAL MCG, DAILY, Required INTRATHECAL Intervention to Prevent Permanent Impairment/Damage Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Oral Baclofen C Date:03/31/04ISR Number: 4328426-5Report Type:Expedited (15-DaCompany Report #PHBS2004SE04163 Age:89 YR Gender:Male I/FU:I Outcome Dose Death Other PT Report Source Product Role Manufacturer Lioresal PS Novartis Sector: Pharma Triobe C Route Duration Difficulty In Walking Drug Level Increased Fatigue Intentional Misuse Pneumonia Date:04/02/04ISR Number: 4330283-8Report Type:Expedited (15-DaCompany Report #PHRM2004FR01370 Age:69 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Cardiac Failure Initial or Prolonged Confusional State 10 mg/day 5760 MIN Dyspnoea Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Date:04/02/04ISR Number: 4330286-3Report Type:Expedited (15-DaCompany Report #PHBS2004SE04163 Age:89 YR Gender:Male I/FU:F Outcome Dose Death Other 22-Aug-2005 Page: 221 PT Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Triobe C Duration Difficulty In Walking Drug Level Increased Fatigue Intentional Misuse Pneumonia 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/05/04ISR Number: 4334304-8Report Type:Expedited (15-DaCompany Report #20041774 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL PT Report Source Product Role Meningitis Streptococcal Wound Secretion Health Professional Lioresal Intrathecal(Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route MCG, DAILY, INTRATHECAL Date:04/05/04ISR Number: 4334359-0Report Type:Expedited (15-DaCompany Report #20041768 Age:4 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization INTRATHECAL DAILY, Initial or Prolonged INTRATHECAL Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Autonomic Nervous System Imbalance Health Professional Lioresal Intrathecal (Baclofen Injection) PS Blood Pressure Fluctuation Clonus Convulsion Drug Withdrawal Syndrome Hypoxia Muscle Spasticity Pneumonia Pyrexia Rales Respiratory Distress Respiratory Failure Tachycardia Tremor Wheezing Date:04/08/04ISR Number: 4335915-6Report Type:Expedited (15-DaCompany Report #04-04-0494 Age:36 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization - PT Report Source Product Autonomic Nervous System Foreign Baclofen Tablets - Role Initial or Prolonged 10MG HS ORAL Imbalance Other Blood Creatine Phosphokinase Increased Disorientation Drug Withdrawal Syndrome Muscle Rigidity Ipi PS Amitriptyline C Ipi ORAL Route Date:04/09/04ISR Number: 4335860-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB01654 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 10 mg, TID PT Anaemia Duodenal Ulcer Report Source Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Haemorrhage Date:04/09/04ISR Number: 4335861-8Report Type:Expedited (15-DaCompany Report #PHFR2004GB01655 Age:36 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 222 12:15 PM PT Autonomic Nervous System Imbalance Blood Creatine FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Phosphokinase Increased Disorientation Drug Withdrawal Syndrome Muscle Rigidity Dose Report Source Product Role Manufacturer Route Baclofen PS Novartis Sector: Pharma ORAL Duration Neuroleptic Malignant Syndrome 10mg/nocte Amitriptyline C ORAL 50mg/nocte Date:04/09/04ISR Number: 4336483-5Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Disability PT Company Report #CTU 216356 Report Source Product Role Manufacturer Route Baclofen 10mg Don'T Know - Is "Major Pharm A Mfr? PS ORAL Clonazepam SS ORAL Duration Headache Screaming Tic ONE TABLET, DAILY, ORAL 11/2 TABLET TWICE DAILY ORAL Date:04/12/04ISR Number: 4339539-6Report Type:Expedited (15-DaCompany Report #20041771 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Enterococcal Infection Initial or Prolonged Meningitis INTRATHECAL MCG, DAILY, Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS INTRATHECAL Date:04/13/04ISR Number: 4337273-XReport Type:Expedited (15-DaCompany Report #PHBS2004CA01117 Age:27 YR Gender:Male I/FU:F Manufacturer Route Outcome Dose Other PT Report Source Product Role Manufacturer Route Abnormal Behaviour Agitation Lioresal PS Novartis Sector: Pharma ORAL Anger Antisocial Behaviour Lioresal Novartis Sector: Pharma ORAL Depression Drug Hypersensitivity Lioresal Novartis Sector: Pharma ORAL Dry Mouth Dysphagia Lioresal Novartis Sector: Pharma ORAL Novartis Sector: Pharma ORAL Novartis Sector: Pharma ORAL Duration 1 tablet/day 4320 MIN 1 tablet, BID 1 tablet, TID SS 4320 MIN SS 4320 MIN SS 2 tablets, Eye Disorder BID 4320 MIN Hallucination Hyperhidrosis Lioresal SS 2 tablets, Infrequent Bowel TID 1 tablet/day 2880 MIN Movements Insomnia Lioresal Lethargy Domperidone 5760 MIN UNKNOWN Mood Swings Paranoia Thyroid Function Test Abnormal Urine Output Decreased 22-Aug-2005 Page: 223 SS 12:15 PM C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/19/04ISR Number: 4343705-3Report Type:Expedited (15-DaCompany Report #KII-2004-0009468 Age:30 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL Other PT Report Source Product Role Manufacturer Route Acidosis Alanine Aminotransferase Study Health Oxycodone Hydrochloride PS ORAL Increased Anion Gap Increased Professional Other Hydrocodone W/Acetaminophen SS ORAL Baclofen (Baclofen) SS ORAL ORAL Aspartate ORAL Aminotransferase Increased Asthenia Blood Bicarbonate Decreased Blood Bilirubin Increased Blood Potassium Decreased Blood Pressure Systolic Decreased Body Temperature Decreased Chromaturia Coma Convulsion Diarrhoea Drug Screen Positive Eye Rolling Heart Rate Decreased Heart Rate Increased Liver Disorder Multiple Drug Overdose Mydriasis Oliguria Prothrombin Time Prolonged Pupil Fixed Rhonchi Vomiting Date:04/19/04ISR Number: 4344071-XReport Type:Expedited (15-DaCompany Report #20031649 Age: Gender:Female I/FU:F Outcome Dose Death INTRATHECAL PT Report Source Product Role Foreign Health Professional Lioresal Intrathecal (Baclofen Injection) 2000mcg/Ml PS Antibiotics Dexamethasone C C Manufacturer Route Duration Coma Device Failure Hypertonia MCG, DAILY, Hypotonia INTRATHECAL Proteus Infection Respiratory Failure Urosepsis Date:04/21/04ISR Number: 4343187-1Report Type:Expedited (15-DaCompany Report #PHRM2004FR01508 Age:64 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Dermatitis Exfoliative Initial or Prolonged Erythema 5 mg, TID 12960MIN Pruritus INTRAVENOUS 1 g, TID 11520MIN Purpura 1000 mg, BID 2880 MIN Rash Maculo-Papular INTRAVENOUS 1 DF, TID 10080MIN 200 mg, BID 22-Aug-2005 Page: 224 11520MIN 12:15 PM Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Augmentin Injection SS Pyostacine SS Gentalline C Oflocet C ORAL ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Loxen C Insulatard C Humalog C ORAL 150 mg/day SUBCUTANEOUS SUBCUTANEOUS Date:04/21/04ISR Number: 4345636-1Report Type:Expedited (15-DaCompany Report #20041811 Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Blood Pressure Ambulatory Initial or Prolonged Abnormal INTRATHECAL MCG, DAILY , Coma INTRATHECAL Medication Error Overdose Somnolence Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Date:04/21/04ISR Number: 4345637-3Report Type:Expedited (15-DaCompany Report #20041748 Age: Gender:Female I/FU:F Outcome PT Dose Duration Hospitalization Cerebrospinal Fluid Initial or Prolonged Leakage INTRATHECAL MCG, DAILY, Lymphoedema INTRATHECAL Meningitis Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Date:04/23/04ISR Number: 4344763-2Report Type:Expedited (15-DaCompany Report #PHBS2004IE05132 Age: Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Duration Gastrointestinal Haemorrhage Date:04/28/04ISR Number: 4349760-9Report Type:Expedited (15-DaCompany Report #04-04-0599 Age: Gender:Male I/FU:I Outcome Dose Death 5MG TID Other PT Report Source Product Role Manufacturer Cerebrovascular Accident Foreign Baclofen-Ipi Tablets PS Ipi Coma Musculoskeletal Stiffness Renal Impairment Sudden Death Other Aspirin Trimethoprim Salbutamol Oxybutynin C C C C Route Duration Date:04/29/04ISR Number: 4350043-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB01654 Age:74 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 20 mg, TID PT Report Source Product Role Manufacturer Route Anaemia Duodenal Ulcer Baclofen PS Novartis Sector: Pharma ORAL Haemorrhage Oxybutynin C ORAL Haemorrhage Rabeprazole C ORAL Nephrolithiasis Ferrous Gluconate C ORAL 2.5 mg, BID 10 mg/day UNK, PRN 22-Aug-2005 Page: 225 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/29/04ISR Number: 4352673-XReport Type:Expedited (15-DaCompany Report #20041819 Age: Gender:Female I/FU:I Outcome PT Dose Duration Required Weight Decreased Intervention to INTRATHECAL MCG, DAILY, Prevent Permanent INTRATHECAL Impairment/Damage Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route Manufacturer Route Date:04/29/04ISR Number: 4353011-9Report Type:Expedited (15-DaCompany Report #20041818 Age: Gender: I/FU:F Outcome Dose Death PT Report Source Product Role Bradycardia Cardiac Arrest Foreign Health Lioresal Intrathecal (Baclofen Injection) PS Pain Professional Duration INTRATHECAL DAILY, INTRATHECAL Procedural Complication Syncope Vasovagal Date:05/04/04ISR Number: 4353176-9Report Type:Direct Age:41 YR Gender:Female I/FU:I Outcome Dose PT Company Report #CTU 217952 Report Source Product Role Baclofen 10 Mg And 15 Mg PS Duration Neutropenia 10-15 MG TID -QID BY MOUTH Date:05/06/04ISR Number: 4353892-9Report Type:Expedited (15-DaCompany Report #PHFR2004GB01886 Age: Gender: I/FU:I Outcome Dose PT Duration Report Source Product Role Other Atrioventricular Block Baclofen PS Dantrolene C Novartis Sector: Pharma Date:05/07/04ISR Number: 4356502-XReport Type:Expedited (15-DaCompany Report #PHBS2004NL05381 Age:40 YR Gender:Female I/FU:I Outcome Dose PT Report Source Product Dysgeusia Parosmia Health Professional Other Lioresal (Baclofen) Solution For Injection Nifedipine (Nifedipine) Amiloride W/Hydrochlorothiazid e (Amiloride) Tramadol (Tramadol) Carbamazepine (Carbamazepine) Role Manufacturer Route Duration PS C C C C Date:05/14/04ISR Number: 4358475-2Report Type:Expedited (15-DaCompany Report #PHBS2004IE05132 Age: Gender:Unknown I/FU:F Outcome Dose Other PT Gastrointestinal Haemorrhage 5 mg, BID 22-Aug-2005 Page: 226 Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Duration 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dantrolene UNKNOWN Date:05/17/04ISR Number: 4359226-8Report Type:Direct Age:61 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 10 MG QID Initial or Prolonged PT Company Report #CTU 218739 Report Source Mental Status Changes Date:05/17/04ISR Number: 4359684-9Report Type:Direct Age:48 YR Gender:Female I/FU:I Outcome Dose C UNK, UNK PT Product Role Manufacturer Route Baclofen PS Oxycodone Fentanyl Temazepam C C C Role Manufacturer Route PS Zenith SS Mylan Company Report #CTU 218832 Report Source Product Duration Weight Increased Baclofen 20 Mg 6 Times A Day Zenith Nadolol 80 Mg A Day Mylan Lipitor 10 Mg A D Oral Amitriptylin 50 Mg Ad Oral SS SS Date:05/17/04ISR Number: 4360834-9Report Type:Expedited (15-DaCompany Report #PHRM2004FR00853 Age:48 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged INTRATRACHEAL PT Report Source Product Role Headache Hyperhidrosis Hypotension Health Professional Other Lioresal Intrathecal (Baclofen) Solution For Injection PS 50 UG, Ileus Paralytic ONCE/SINGLE, Urinary Retention INTRATHECAL 1 DAY Manufacturer Route Forlax (Macrogol) Powder C Date:05/17/04ISR Number: 4360835-0Report Type:Expedited (15-DaCompany Report #PHRM2004FR01564 Age:78 YR Gender:Male I/FU:I Outcome PT Dose Duration Life-Threatening Coma Hospitalization Depressed Level Of Initial or Prolonged Consciousness INTRATHECAL INTRATHECAL Drug Level Above Therapeutic Escherichia Infection Implant Site Infection Interstitial Lung Disease Kussmaul Respiration Meningitis Bacterial Miosis Musculoskeletal Stiffness Pneumonia Aspiration Shock 22-Aug-2005 Page: 227 12:15 PM Report Source Product Role Health Professional Other Lioresal Intratecal (Baclofen) Solution For Injection PS Lopril (Captopril) Nozinan (Levomepromazine Maleate) Captea (Captopril, Hydrochlorothiazide) Tablet C C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/17/04ISR Number: 4361020-9Report Type:Expedited (15-DaCompany Report #20041833 Age: Gender: I/FU:I Outcome PT Dose Duration Hospitalization Catheter Related Initial or Prolonged Complication INTRATHECAL DAILY, Device Failure INTRATHECAL Drug Ineffective Meningitis Overdose Report Source Product Role Foreign Health Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Route Professional Date:05/17/04ISR Number: 4362222-8Report Type:Expedited (15-DaCompany Report #20041833 Age: Gender: I/FU:F Outcome PT Dose Duration Hospitalization Catheter Related Initial or Prolonged Complication INTRATHECAL MCG, DAILY, Device Failure INTRATHECAL Device Ineffective Overdose Report Source Product Role Foreign Health Lioresal Intrathecal (Baclofen Injection) PS Professional Date:05/18/04ISR Number: 4359916-7Report Type:Expedited (15-DaCompany Report #PHFR2004GB01886 Age:42 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Dantrolene SS Duration Atrioventricular Block Cardiac Arrest Convulsion Electrocardiogram Pr Prolongation Date:05/19/04ISR Number: 4360118-9Report Type:Expedited (15-DaCompany Report #PHBS2003CH14515 Age:67 YR Gender:Male I/FU:F ORAL ORAL Outcome PT Dose Duration Hospitalization Blood Creatinine Initial or Prolonged Increased 10 mg, TID 2880 MIN Other Bradycardia UNKNOWN 1 mg/day 1440 MIN Coma INTRAVENOUS Drug Interaction 6 g Drug Level Decreased UNKNOWN Fall UNKNOWN Somnolence UNKNOWN Stupor UNKNOWN 50 mg/day Report Source Product Role Manufacturer Route Health Professional Lioresal PS Novartis Sector: Pharma ORAL Temesta SS Floxapen C DRIP Insulin C Actrapid C Benerva C Prednisone C Diuretics C UNKNOWN Date:05/19/04ISR Number: 4360124-4Report Type:Expedited (15-DaCompany Report #PHFR2004GB01654 Age:74 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 20 mg, TID PT Report Source Product Role Manufacturer Route Anaemia Duodenal Ulcer Health Professional Baclofen PS Novartis Sector: Pharma ORAL Duodenal Ulcer Oxybutynin C ORAL Haemorrhage Rabeprazole C ORAL Nephrolithiasis Ferrous Gluconate C ORAL Lactulose C ORAL 2.5 mg, BID 10 mg/day UNK, PRN 22-Aug-2005 Page: 228 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/19/04ISR Number: 4364533-9Report Type:Expedited (15-DaCompany Report #PHFR2004GB01886 Age: Gender:Unknown I/FU:I Outcome Dose PT Report Source Product Atrioventricular Block Health Professional Other Baclofen (Baclofen ) Unknown Dantrolene (Dantrolene) Role Manufacturer Route Manufacturer Route Duration PS C Date:05/28/04ISR Number: 4368551-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB01886 Age:42 YR Gender:Female I/FU:F Outcome Dose PT Report Source Product Role Atrioventricular Block Cardiac Arrest Foreign Health Baclofen (Baclofen) PS ORAL Convulsion Electrocardiogram Pr Professional Other Dantrolene (Dantrolene) SS ORAL Duration ORAL ORAL Prolongation Date:05/28/04ISR Number: 4369769-9Report Type:Expedited (15-DaCompany Report #20041849 Age: Gender:Female I/FU:F Outcome PT Dose Duration Hospitalization Chills Initial or Prolonged Confusional State INTRATHECAL MCG, DAILY, Drug Withdrawal Syndrome INTRATHECAL Hallucination Medication Error Muscle Spasms Pyrexia Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Date:06/02/04ISR Number: 4368570-XReport Type:Expedited (15-DaCompany Report #BE-JNJFOC-20040403804 Age: Gender:Male I/FU:I Manufacturer Route Outcome PT Dose Duration Death Drug Interaction Hospitalization Encephalitis TRANSDERMAL 100 UG/HR, Initial or Prolonged Insomnia TRANSDERMAL Meningitis Myalgia 10 MG, 3 IN 1 Refusal Of Treatment By DAY, ORAL Patient Refusal Of Treatment By Relative Respiratory Depression Report Source Product Role Foreign Health Durogesic (Fentanyl) Patch PS Lioresal (Baclofen) Tablets SS Voltaren (Diclofenac Sodium) C Manufacturer Route Professional ORAL Date:06/02/04ISR Number: 4371696-8Report Type:Expedited (15-DaCompany Report #20041785 Age: Gender:Male I/FU:F Outcome PT Dose Duration Hospitalization Blood Creatine Initial or Prolonged Phosphokinase Increased INTRATHECAL UNK MCG, Drug Withdrawal Syndrome DAILY; Hypertonia INTRATHECAL Muscle Spasticity Pyrexia Tachycardia 22-Aug-2005 Page: 229 12:15 PM Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/02/04ISR Number: 4371993-6Report Type:Expedited (15-DaCompany Report #PHBS2004SE06272 Age: Gender:Male I/FU:I Outcome Dose PT Report Source Product Role Blood Alkaline Phosphatase Increased Transaminases Increased Health Professional Other Lioresal (Baclofen) PS Manufacturer Route Route Duration Date:06/03/04ISR Number: 4369014-4Report Type:Expedited (15-DaCompany Report #PHNU2004DE01939 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged UNKNOWN PT Report Source Hyponatraemia Inappropriate Product Role Manufacturer Lioresal PS Novartis Sector: Pharma Product Role Manufacturer Route Baclofen Radiation PS SS Antidiuretic Hormone Secretion Pneumonia Date:06/03/04ISR Number: 4371662-2Report Type:Direct Age:60 YR Gender: I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Company Report #CTU 220055 Report Source Implant Site Reaction Medication Error Date:06/04/04ISR Number: 4371402-7Report Type:Expedited (15-DaCompany Report #04-06-0788 Age:42 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Cardio-Respiratory Arrest Convulsion Foreign Other Baclofen - Ipi Tablets PS Ipi ORAL Dantrolene SS Duration ORAL Electrocardiogram Pr ORAL Prolongation ORAL Date:06/07/04ISR Number: 4375669-0Report Type:Expedited (15-DaCompany Report #20041867 Age: Gender:Male I/FU:I Outcome Dose Other INTRATHECAL PT Report Source Product Role Central Nervous System Infection Health Professional Lioresal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Duration DAILY, White Blood Cell Count INTRATHECAL Increased Date:06/08/04ISR Number: 4374396-3Report Type:Direct Age: Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Baclofen PS Duration Cardiac Arrest Infusion Related Reaction Date:06/09/04ISR Number: 4375823-8Report Type:Direct Age:55 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 230 Company Report #CTU 220306 12:15 PM Company Report #CTU 220433 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Other PT Dose Report Source Product Role Morphine Baclofen PS SS Manufacturer Route Manufacturer Route Duration Multiple Drug Overdose Date:06/09/04ISR Number: 4377999-5Report Type:Expedited (15-DaCompany Report #UKP04000167 Age:42 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Atrioventricular Block Cardiac Arrest Foreign Health Dantrium (Dantrolene Sodium) PS ORAL Convulsion Professional Electrocardiogram Pr Other Baclofen (Baclofen) SS ORAL Duration 25 MG, 3/DAY, ORAL ORAL Prolongation Date:06/10/04ISR Number: 4375216-3Report Type:Expedited (15-DaCompany Report #PHRM2004FR01508 Age:64 YR Gender:Male I/FU:F Outcome PT Dose Duration Hospitalization Dermatitis Exfoliative Initial or Prolonged Erythema 5 mg, TID 12960MIN Pruritus INTRAVENOUS 1 g, TID 11520MIN Purpura 1000 mg, BID 2880 MIN Rash Maculo-Papular INTRAVENOUS 1 DF, TID 10080MIN 200 mg, BID Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Augmentin Injection SS Pyostacine SS Gentalline C Oflocet C ORAL Loxen C ORAL Insulatard C Humalog C ORAL 11520MIN 150 mg/day SUBCUTANEOUS 8640 MIN SUBCUTANEOUS 8640 MIN Tenormine C ORAL Zestril C ORAL Mediatensyl C ORAL Esidrex Lovenox C C ORAL 100 mg/day 20 mg/day 60 mg/day SUBCUTANEOUS 20160MIN Date:06/10/04ISR Number: 4375217-5Report Type:Expedited (15-DaCompany Report #PHFR2004GB02316 Age:41 YR Gender:Female I/FU:I Outcome Dose Other 5 mg, TID PT Report Source Product Role Manufacturer Route Baclofen PS Novartis Sector: Pharma ORAL Duration Swollen Tongue 5760 MIN Date:06/10/04ISR Number: 4375566-0Report Type:Expedited (15-DaCompany Report #PHHO2004DE07738 Age:57 YR Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Blood Creatinine Increased Creatinine Renal Clearance Decreased Health Professional Baclofen PS Novartis Sector: Pharma ORAL Duration Sti 571 Vs Ifn-Alpha + Cytarabine SS ORAL Diclo-Phlogont Voltaren SS SS ORAL ORAL 400 mg, QD 22-Aug-2005 Page: 231 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/10/04ISR Number: 4379335-7Report Type:Expedited (15-DaCompany Report #KII-2004-0011034 Age:39 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Manufacturer Route Aggression Blood Pressure Diastolic Decreased Blood Pressure Increased Study Health Professional Other Oxycontin Tablets (Oxycodone Hydrochloride) Cr Tablet PS ORAL Heart Rate Increased Intentional Misuse Other Hypnotics And Sedatives () SS ORAL Metabolic Acidosis Respiratory Acidosis Neurontin (Gabapentin) SS ORAL Respiratory Rate Ssri() SS ORAL Increased Baclofen (Baclofen) SS ORAL Urine Cannabinoids Increased Trazodone (Trazodone) SS ORAL Vomiting Tetrahydrocannabinol (Tetrahydrocannabino l) SS ORAL ORAL ORAL ORAL ORAL ORAL Date:06/15/04ISR Number: 4381680-6Report Type:Expedited (15-DaCompany Report #KII-2004-0011112 Age:52 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Manufacturer Route Abnormal Behaviour Aggression Agitation Anger Study Health Professional Other Oxycontin Tablets(Oxycodone Hydrochloride) Cr Tablet PS ORAL Aspartate Aminotransferase Benzodiazepine Derivatives () SS ORAL Increased Baclofen (Baclofen) SS ORAL Back Pain Blood Alkaline Docusate Sodium (Docusate Sodium) SS ORAL ORAL ORAL ORAL Phosphatase Increased Blood Glucose Increased Blood Pressure Systolic Increased Blood Urea Increased Body Temperature Decreased Convulsion Delirium Disorientation Drug Abuser Drug Withdrawal Syndrome Grunting Hyperhidrosis Loss Of Consciousness Moaning Overdose Patient Restraint Pupillary Reflex Impaired Somnolence Stupor Tremor Urinary Incontinence White Blood Cell Count Increased White Blood Cells Urine Positive 22-Aug-2005 Page: 232 12:15 PM Marijuana (Cannabis) Tricyclic Antidepressants() Ultram (Tramadol Hydrochloride) Antiepileptics () SS SS SS SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/15/04ISR Number: 4381949-5Report Type:Expedited (15-DaCompany Report #PHHO2004DE07738 Age:57 YR Gender:Unknown I/FU:I Outcome Dose Other 400 MG, QD, PT Report Source Product Role Manufacturer Route Blood Creatinine Foreign Lioresal PS ORAL Increased Study Creatinine Renal Clearance Decreased Health Professional Voltaren (Diclofenac Resinate) SS ORAL Other Baclofen (Baclofen) SS ORAL Diclo-Phlogont (Diclofenac Sodium) SS ORAL Duration ORAL ORAL ORAL ORAL Date:06/15/04ISR Number: 4382009-XReport Type:Expedited (15-DaCompany Report #PHNU2004DE01939 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Hyponatraemia Inappropriate Antidiuretic Hormone Secretion Pneumonia Health Professional Other Lioresal (Baclofen) PS Manufacturer Route Date:06/16/04ISR Number: 4378730-XReport Type:Expedited (15-DaCompany Report #PHNU2004DE01939 Age:56 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 80mg/day PT Hyponatraemia Inappropriate Antidiuretic Hormone Secretion Pneumonia Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Date:06/16/04ISR Number: 4382709-1Report Type:Expedited (15-DaCompany Report #D-04-023 Age:82 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 5 MG TID PO Initial or Prolonged PT Report Source Product Role Coordination Abnormal Consumer Baclofen 10 Mg; Usl PS Alprazolam Aricept Neurontin Oxycontin Trazdone 50 Mg Qhs (From Unk Contin) Endocet Morphine Pca Intrathecal (From Unk (Contin)) C C C C Hallucination Loss Of Consciousness Pneumonia Manufacturer Route ORAL C C C Date:06/18/04ISR Number: 4380727-0Report Type:Expedited (15-DaCompany Report #PHBS2004BR07749 Age:25 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Blood Creatine Phosphokinase Increased Baclofen PS Novartis Sector: Pharma Dystonia Carbamazepine SS Viral Infection Trihexyphenidyl SS Clonazepam SS Tetrabenazine C Duration UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN 22-Aug-2005 Page: 233 12:15 PM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Flurazepam C Clobazam Pimozide C C UNKNOWN UNKNOWN Date:06/18/04ISR Number: 4383581-6Report Type:Expedited (15-DaCompany Report #20040600315 Age:54 YR Gender:Male I/FU:I Outcome Dose Duration Death Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Manufacturer Gastrointestinal Disorder Hypotension Mental Status Changes Overdose Pneumonia Aspiration Pyrexia Respiratory Failure Health Professional Duramorph (Morphine Sulfate, Baxter) Baclofen Ambien Amitriptyline Coumadin Ocybutynin Valium Lipitor Macrodantin Neurontin Prozac Zanaflex Miralax Peri-Colace PS SS C C C C C C C C C C C C Baxter Manufacturer Route Date:06/21/04ISR Number: 4383929-2Report Type:Expedited (15-DaCompany Report #20041867 Age: Gender:Male I/FU:F Outcome Dose Other INTRATHECAL PT Report Source Product Role Central Nervous System Infection Health Professional Lioresal (Baclofen Injection) PS Duration DAILY, INTRATHECAL Date:06/21/04ISR Number: 4385114-7Report Type:Expedited (15-DaCompany Report #PHNU2003DE04094 Age: Gender:Male I/FU:F Route Outcome Dose Death INTRATHECAL PT Report Source Product Role Foreign Health Lioresal Intrathecal (Baclofen) PS Manufacturer Route Manufacturer Route Duration Drug Ineffective Drug Withdrawal Syndrome TEST DOSE; Electroencephalogram Professional INTRATHECAL Abnormal Intracranial Pressure Increased Medical Device Complication Sudden Death Other Date:06/25/04ISR Number: 4387715-9Report Type:Expedited (15-DaCompany Report #20041897 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL PT Headache Intentional Misuse Suicide Attempt UNK MCG, Report Source Product Role Health Professional Lioresal Intrathecal(Baclofen Injection) PS Oral Baclofen C DAILY, INTRATHECAL 22-Aug-2005 Page: 234 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/25/04ISR Number: 4387721-4Report Type:Expedited (15-DaCompany Report #20041895 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL PT Coma Csf Culture Positive Culture Wound Positive UNK MCG, Meningitis Report Source Product Role Health Professional Lioresal Intrathecal(Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route DAILY, Sepsis INTRATHECAL Staphylococcal Infection Streptococcal Infection Date:06/25/04ISR Number: 4387723-8Report Type:Expedited (15-DaCompany Report #20041903 Age: Gender:Male I/FU:I Outcome PT Dose Duration Required Burning Sensation Intervention to Dysgeusia Prevent Permanent Hypoaesthesia INTRATHECAL UNK MCG, Impairment/Damage Oedema Peripheral DAILY, Pain INTRATHECAL Report Source Product Role Health Professional Lioresal Intrathecal(Baclofen Injection) PS Dilaudid C Date:06/25/04ISR Number: 4387724-XReport Type:Expedited (15-DaCompany Report #20041860 Age: Gender:Male I/FU:F Outcome PT Dose Duration Required Catheter Related Intervention to Complication Prevent Permanent Confusional State INTRATHECAL UNK MCG, Impairment/Damage Convulsion DAILY, Report Source Product Role Health Professional Lioresal Intrathecal(Baclofen Injection) PS Enterococcal Sepsis INTRATHECAL Headache Hypertonia Hypotension Medication Error Post Procedural Complication Pruritus Self-Medication Urinary Tract Infection Date:06/25/04ISR Number: 4388266-8Report Type:Expedited (15-DaCompany Report #PHHO2004US00786 Age:55 YR Gender:Male I/FU:I Outcome Death Hospitalization Initial or Prolonged 22-Aug-2005 Page: 235 12:15 PM PT Confusional State Crepitations Decreased Appetite Dehydration Dyspnoea Hyperkalaemia Hyponatraemia Hypotension Hypoxia Infection Malignant Neoplasm Progression Neurological Symptom FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Oral Intake Reduced Renal Failure Acute Respiratory Distress Dose Report Source Product Study Baclofen (Baclofen, Baclofen) Glivec (Sti571/Cgp57148b T35717+Caps) Capsule Role Manufacturer Route Duration Somnolence Urinary Tract Infection Enterococcal Urine Output Decreased PS SS ORAL 500 MG, QD ORAL Remeron (Mirtazapine) Lovenox (Heparin-Fraction, Sodium Salt) Thorazine (Chlorpromazine Hydrochloride) Paxil (Paroxetine Hydrochloride) SS C C C Date:06/28/04ISR Number: 4389093-8Report Type:Expedited (15-DaCompany Report #US-SHR-03-019043 Age:62 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged SUBCUTANEOUS PT Report Source Product Role Coma Injection Site Cellulitis Consumer Betaseron (Interferon Beta-1b) Injection, 250mcg PS Baclofen (Baclofen) SS Manufacturer Route Manufacturer Route 8 MIU, EVERY 2D, HS, SUBCUTANEOUS Date:06/28/04ISR Number: 4390332-8Report Type:Expedited (15-DaCompany Report #2004040267 Age: Gender:Male I/FU:I Outcome Dose PT Duration Report Source Product Role Hospitalization Initial or Prolonged ORAL Other 25 MG (2 IN 1 Abdominal Pain Upper Abnormal Behaviour Condition Aggravated Consumer Neurontin (Gabapentin) PS Diazepam (Diazepam) SS Baclofen (Baclofen) All Other Therapeutic Products (All Other Therapeutic Products) Oxybutynin Hydrochloride (Oxybutynin Hydrochloride) Warfarin Sodium (Warfarin Sodium) Potassium (Potassium) Fluticasone Propionate (Fluticasone Propionate) Combivent (Ipratropium SS Drug Ineffective D) Drug Interaction Drug Withdrawal Syndrome Feeling Abnormal Hallucination Medication Error Mental Disorder Pyrexia 22-Aug-2005 Page: 236 12:15 PM SS C C C C ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Bromide, Salbutamol Sulfate) C Date:07/08/04ISR Number: 4392851-7Report Type:Expedited (15-DaCompany Report #PHBS2004JP08731 Age: Gender: I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Lioresal PS Novartis Sector: Pharma Route Duration Deep Vein Thrombosis Date:07/13/04ISR Number: 4395433-6Report Type:Expedited (15-DaCompany Report #PHRM2004FR02278 Age:66 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Arrhythmia Bradycardia Health Professional Lioresal PS Novartis Sector: Pharma ORAL Route Duration 35 mg/day Dyspnoea Date:07/13/04ISR Number: 4395441-5Report Type:Expedited (15-DaCompany Report #PHBS2004JP08731 Age: Gender: I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Manufacturer Deep Vein Thrombosis Health Professional Lioresal PS Novartis Sector: Pharma Manufacturer Date:07/16/04ISR Number: 4406641-XReport Type:Expedited (15-DaCompany Report #REFE00204002334 Age:60 YR Gender:Male I/FU:F Outcome Dose Duration Life-Threatening 10 MG DAILY PO, 10 MG PT Report Source Product Role Blood Pressure Decreased Foreign Cannador (Cannador) PS Circulatory Collapse Study Route ORAL Pulse Absent Health Sinus Bradycardia Professional DAILY PO Baclofen (Baclofen) SS ORAL 30 MG DAILY Other PO Date:07/16/04ISR Number: 4406642-1Report Type:Expedited (15-DaCompany Report #DRON00204002327 Age:50 YR Gender:Female I/FU:F Outcome Dose Other 2.5 MG BID, PT Report Source Product Role Manufacturer Route Circulatory Collapse Foreign Marinol (Dronabinol) PS ORAL Confusional State Study Somnolence Speech Disorder Health Professional Amitripytline (Amitriptyline) SS ORAL Baclofen (Baclofen) SS ORAL Tizanidine (Tizanidine) SS ORAL Duration PO 200 MG DAILY Other PO 70 MG DAILY PO 32 MG DAILY PO 22-Aug-2005 Page: 237 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/20/04ISR Number: 4402845-0Report Type:Direct Age:78 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening 5 MG PO TID X PT Company Report #CTU 223124 Report Source Abnormal Dreams Product Role Baclofen PS Sinemet Zoloft C C Manufacturer Route ORAL Coma 3 D , 10 MG Dysphagia TID X 3D, 20 Hallucination MG TID X 2 D Oral Intake Reduced Physical Examination Abnormal Speech Disorder Date:07/21/04ISR Number: 4403689-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB02844 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Route Duration Peptic Ulcer 20 mg, BID Date:07/26/04ISR Number: 4407380-1Report Type:Expedited (15-DaCompany Report #PHBS2004US09673 Age:32 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Other PT Report Source Product Role Manufacturer Haemoglobin Decreased Haemolysis Health Professional Baclofen PS Novartis Sector: Pharma Zanaflex $El SS Neurontin C Ditropan C 36 mg/d UNKNOWN UNKNOWN Route ORAL Date:07/29/04ISR Number: 4413959-3Report Type:Expedited (15-DaCompany Report #PHBS2004JP08731 Age: Gender: I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Deep Vein Thrombosis Health Professional Other Lioresal (Baclofen) PS Manufacturer Route Manufacturer Route Date:07/29/04ISR Number: 4414463-9Report Type:Expedited (15-DaCompany Report #2004-DE-03937GD Age: Gender: I/FU:I Outcome Dose Duration Congenital Anomaly INTRA-UTERINE PT Report Source Product Role Drug Exposure During Pregnancy Foreign Literature Ibuprofen (Ibuprofen) PS Paracetamol (Paracetamol) SS Diazepam (Diazepam) SS Baclofen (Baclofen) SS IU Ventricular Septal Defect INTRA-UTERINE IU INTRA-UTERINE IU INTRA-UTERINE IU Date:07/29/04ISR Number: 4414651-1Report Type:Expedited (15-DaCompany Report #20031586 Age:9 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 238 12:15 PM PT Bruxism Catheter Related Complication Device Failure FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Granuloma Muscle Rigidity Dose Report Source Product Role Health Professional Lioresal Intrathecal(Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route Manufacturer Route Duration INTRATRACHEAL DAILY, INTRATHECAL Date:07/29/04ISR Number: 4414672-9Report Type:Expedited (15-DaCompany Report #20041759 Age: Gender:Female I/FU:I Outcome Dose Duration Required Intervention to Prevent Permanent INTRATHECAL Impairment/Damage PT Report Source Product Role Meningitis Health Professional Lioresal Intrathecal(Baclofen Injection) PS Date:07/29/04ISR Number: 4414673-0Report Type:Expedited (15-DaCompany Report #20041923 Age:20 YR Gender:Female I/FU:I Outcome Dose Death INTRATHECAL PT Report Source Product Role Death Health Professional Lioresal Intrathecal9baclofen Injection) PS Duration DAILY, INTRATHECAL Date:08/05/04ISR Number: 4422425-0Report Type:Expedited (15-DaCompany Report #PHBS2004US09673 Age:32 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening PT Report Source Product Glucose-6-Phosphate Dehydrogenase Deficiency Foreign Health Zanaflex $El (Tizanidine Role Haemoglobin Decreased Professional Hydrochloride) PS Haemolysis Other Baclofen (Baclofen) Neurontin (Gabapentin) Ditropan (Oxybutynin Hydrochloride) SS ORAL 36 MG/D C C Date:08/10/04ISR Number: 4425814-3Report Type:Expedited (15-DaCompany Report #2004033685 Age:43 YR Gender:Female I/FU:F Outcome Dose Death Other ORAL 22-Aug-2005 Page: 239 PT Report Source Product Role Completed Suicide Drug Level Above Foreign Health Neurontin (Gabapentin) PS Therapeutic Intentional Misuse Muscle Relaxant Drug Level Above Therapeutic Victim Of Homicide Professional Baclofen (Baclofen) SS Manufacturer Route Duration 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/12/04ISR Number: 4426046-5Report Type:Expedited (15-DaCompany Report #04-08-1139 Age: Gender:Male I/FU:I Outcome Dose Other 20MG BD PT Report Source Product Role Manufacturer Route Peptic Ulcer Foreign Baclofen PS Ipi ORAL Manufacturer Route Duration Health Professional Other Date:08/18/04ISR Number: 4431484-0Report Type:Expedited (15-DaCompany Report #20041951 Age:32 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Required MCG, DAILY, Intervention to INTRACHECAL Prevent Permanent Impairment/Damage PT Report Source Product Role Drug Ineffective Drug Tolerance Decreased Fluid Retention Health Professional Lioresal Intrathecal(Baclofen Injection) PS Muscle Spasms Pyrexia Seroma Date:08/19/04ISR Number: 4429617-5Report Type:Expedited (15-DaCompany Report #PHRM2004FR02278 Age:66 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Arrhythmia Bradycardia Lioresal PS Novartis Sector: Pharma ORAL Dyspnoea Lioresal Novartis Sector: Pharma ORAL Duration 45 mg/day 30 mg/day Date:08/23/04ISR Number: 4433088-2Report Type:Expedited (15-DaCompany Report #ZANA001328 Age:69 YR Gender:Female I/FU:I SS Outcome Dose Duration Hospitalization Initial or Prolonged 4 MG ORAL Other PT Report Source Product Role Amnesia Blood Creatine Health Professional Zanaflex (Tizanidine Hydrochloride) PS Other Copaxone (Glatiramer Acetate) SS Baclofen (Baclofen) SS Phosphokinase Increased Carotid Artery Stenosis 20 MG DAILY, Confusional State SUBCUTANEOUS Manufacturer Route ORAL SUBCUTANEOUS Delirium ORAL 14 TO 20 MG Encephalopathy TABLETS, ORAL Mental Status Changes Overdose Pain In Extremity Urinary Tract Infection Date:08/24/04ISR Number: 4431077-5Report Type:Expedited (15-DaCompany Report #PHBS2004IE10906 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 240 mg/day 180 mg/day 22-Aug-2005 Page: 240 12:15 PM PT Report Source Product Role Manufacturer Route Dyskinesia Infection Lioresal PS Novartis Sector: Pharma ORAL Muscle Spasticity Lioresal Novartis Sector: Pharma ORAL SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/26/04ISR Number: 4434050-6Report Type:Expedited (15-DaCompany Report #PHHO2004DE07738 Age:57 YR Gender:Unknown I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Baclofen PS Novartis Sector: Pharma ORAL Duration Blood Creatinine Increased Creatinine Renal Clearance Decreased Sti 571 Vs Ifn-Alpha + Cytarabine SS ORAL Diclo-Phlogont Voltaren SS SS ORAL ORAL 400 mg, QD Date:09/02/04ISR Number: 4440038-1Report Type:Expedited (15-DaCompany Report #PHBS2004ZA11247 Age:14 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Agitation Circulatory Collapse Coordination Abnormal Extraocular Muscle Disorder Nystagmus Overdose Respiratory Disorder Date:09/02/04ISR Number: 4441115-1Report Type:Direct Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 10 MG TID PO Report Source PT Product Role Manufacturer Lioresal PS Novartis Sector: Pharma Product Role Manufacturer Baclofen 10 Mg Tablet PS Route Company Report #CTU 226232 Report Source Convulsion Route ORAL Date:09/03/04ISR Number: 4440504-9Report Type:Expedited (15-DaCompany Report #PHBS2004GB11400 Age: Gender:Female I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Other Drug Exposure During Pregnancy Baclofen PS Foetal Distress Syndrome Diazepam SS Novartis Sector: Pharma TRANSPLACENTAL TRANSPLACENTAL Date:09/03/04ISR Number: 4440511-6Report Type:Expedited (15-DaCompany Report #PHBS2004US11398 Age:16 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Depressed Level Of Consciousness Health Professional Baclofen PS Novartis Sector: Pharma Tizanidine Hydrochloride SS Nortriptyline Hydrochloride SS Gabapentin SS Phenelzine SS Ketorolac SS Bethanechol SS Olanzapine SS Duration UNKNOWN Dizziness Tachycardia UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN UNKNOWN 22-Aug-2005 Page: 241 12:15 PM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:09/07/04ISR Number: 4442884-7Report Type:Direct Age: Gender: I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Mental Status Changes Date:09/07/04ISR Number: 4444808-5Report Type:Direct Age:28 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 20 MG TID PO Initial or Prolonged Company Report #CTU 226404 PT Product Role Baclofen PS Manufacturer Route Manufacturer Route Company Report #CTU 226505 Report Source Psychotic Disorder Product Role Baclofen PS ORAL Date:09/13/04ISR Number: 4448171-5Report Type:Expedited (15-DaCompany Report #PHRM2004FR02721 Age:50 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Alanine Aminotransferase Initial or Prolonged Increased 20 mg, TID 7200 MIN Aspartate 100 mg, 5QD 17280MIN Aminotransferase Increased Blood Alkaline Phosphatase Increased Cytolytic Hepatitis Gamma-Glutamyltransferase Increased Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Di-Hydan SS ORAL Date:09/14/04ISR Number: 4448423-9Report Type:Expedited (15-DaCompany Report #PHBS2004ZA11247 Age:14 YR Gender:Female I/FU:F Outcome Dose PT Duration Report Source Product Role Manufacturer Route Hospitalization Agitation UNK, Initial or Prolonged Blood Chloride Increased ONCE/SINGLE 1440 MIN Blood Lactate Dehydrogenase Increased Blood Sodium Decreased Blood Urea Decreased Circulatory Collapse Coma Coordination Abnormal Excitability Extraocular Muscle Disorder Nystagmus Overdose Pco2 Decreased Respiratory Disorder Lioresal PS Benzodiazepines Barbiturates Tricyclic Antidepressants SS SS SS Date:09/14/04ISR Number: 4450378-8Report Type:Expedited (15-DaCompany Report #PHNU2004DE02865 Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Pyrexia Initial or Prolonged INTRATHECAL 600 NG/DAY; Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen) Unknown PS Other 150 NG/DAY; INTRATHECAL 22-Aug-2005 Page: 242 12:15 PM Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Valproate Sodium (Valproate Sodium) Topamax (Topiramate) Sodium Chloride (Sodium Chloride) C C C Date:09/14/04ISR Number: 4450580-5Report Type:Expedited (15-DaCompany Report #20041964 Age: Gender:Female I/FU:F Outcome PT Dose Duration Required Convulsion Intervention to Muscle Spasticity INTRATHECAL MCG, DAILY, Prevent Permanent Sepsis INTRATHECAL Impairment/Damage Date:09/16/04ISR Number: 4454305-9Report Type:Direct Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Route Company Report #CTU 227407 Report Source Mental Status Changes Product Role Baclofen PS Date:09/23/04ISR Number: 4457242-9Report Type:Expedited (15-DaCompany Report #PHFR2004GB03536 Age:4 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 20 mg, TID Other PT Report Source Product Role Manufacturer Extrapyramidal Disorder Facial Spasm Baclofen PS Novartis Sector: Pharma Muscle Spasms Benzhexol C Date:09/28/04ISR Number: 4462221-1Report Type:Expedited (15-DaCompany Report #04-09-1315 Age: Gender:Female I/FU:I Outcome PT Dose Duration Other Drug Exposure During TRANSPLACENTAL TRANSPLANCENT Pregnancy AL Foetal Distress Syndrome TRANSPLACENTAL TRANSPLACENTA Forceps Delivery L Pregnancy Report Source Product Role Manufacturer Foreign Baclofen PS Ipi Diazepam SS Route Health Professional Other Date:10/04/04ISR Number: 4465123-XReport Type:Expedited (15-DaCompany Report #PHBS2002CL09569 Age:41 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Abdominal Distension Abdominal Pain Upper Lioresal PS Novartis Sector: Pharma ORAL Chest Wall Pain Fatigue Lioresal Novartis Sector: Pharma ORAL Flatulence Haematochezia Lioresal Novartis Sector: Pharma ORAL Duration 1 tablet/day SS 2 tablets/day SS 4 tablets/day Diazepam C Omeprazole C UNKNOWN UNKNOWN 22-Aug-2005 Page: 243 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/04/04ISR Number: 4468030-1Report Type:Direct Age:92 YR Gender:Male I/FU:I Outcome Dose Other PT Company Report #CTU 228709 Report Source Product Role Baclofen PS Manufacturer Route Manufacturer Route Manufacturer Route Duration Confusional State Somnolence Tremor Date:10/06/04ISR Number: 4471331-4Report Type:Expedited (15-DaCompany Report #M2004-1416 Age: Gender:Female I/FU:I Outcome PT Dose Duration Other Complication Of Delivery TRANSPLACENTAL TRANS-PLACENT Drug Exposure During AL Pregnancy Foetal Distress Syndrome Pregnancy Report Source Product Role Foreign Diazepam PS Baclofen SS Other Date:10/06/04ISR Number: 4471369-7Report Type:Expedited (15-DaCompany Report #20042012 Age:47 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Abdominal Rigidity Initial or Prolonged Arrhythmia INTRATHECAL MCG, DAILY, Required Cyanosis INTRATHECAL Intervention to Device Failure Prevent Permanent Drug Withdrawal Syndrome Impairment/Damage Hypertension Pyrexia Tachycardia Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Date:10/06/04ISR Number: 4471376-4Report Type:Expedited (15-DaCompany Report #231317K04USA Age:69 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Myocardial Infarction Consumer Health Professional Rebif (Interferon Beta) Baclofen (Baclofen) Beta Blocker (Beta Blocking Agents) Aspirine (Acetylsalicylic Acid) Date:10/07/04ISR Number: 4471401-0Report Type:Expedited (15-DaCompany Report #04-09-1381 Age:19 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 244 12:15 PM PT Condition Aggravated Decreased Activity Device Failure Dyspnoea Dystonia Hyperreflexia Hypertonia Muscle Spasms Post Procedural Complication Role PS SS C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Respiratory Distress Stridor Vocal Cord Disorder Dose Report Source Product Role Literature Baclofen PS Manufacturer Route Manufacturer Route Duration INTRATHECAL 165-180U/DAY Health INTRATHECAL 8 MON Professional Date:10/12/04ISR Number: 4476484-XReport Type:Expedited (15-DaCompany Report #2004070485 Age:19 YR Gender: I/FU:I Outcome Dose Death PT Report Source Product Role Completed Suicide Intentional Misuse Literature Health Gabapentin (Gabapentin) PS ORAL Professional Baclofen (Baclofen) SS ORAL Oxybutynin (Oxybutynin) SS ORAL Duration ORAL ORAL ORAL Date:10/13/04ISR Number: 4505129-5Report Type:Periodic Age:82 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 5 MG TID; PO Initial or Prolonged Company Report #D-04-023 PT Report Source Product Role Coordination Abnormal Consumer Baclofen 10 Mg; Usl PS Alprazolam Aricept Neurontin Oxycontin Trazadone Endocet Morphine Pca Intrathecal C C C C C C Hallucination Loss Of Consciousness Pneumonia C Manufacturer Route ORAL Date:10/13/04ISR Number: 4505130-1Report Type:Periodic Age:8 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization ORAL 4 YR Initial or Prolonged Company Report #DCC 04-005 PT Report Source Product Role Drug Withdrawal Syndrome Consumer Baclofen PS Manufacturer Route ORAL Date:10/18/04ISR Number: 4480401-6Report Type:Expedited (15-DaCompany Report #20042004 Age:14 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Medical Device Initial or Prolonged Complication INTRATHECAL DAILY, Meningitis INTRATHECAL Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Date:10/18/04ISR Number: 4480402-8Report Type:Expedited (15-DaCompany Report #20042004 Age:14 YR Gender:Male I/FU:F Outcome PT Dose Duration Hospitalization Incision Site Initial or Prolonged Complication INTRATHECAL DAILY, Medical Device INTRATHECAL Complication Meningitis Wound Drainage 22-Aug-2005 Page: 245 12:15 PM Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:10/20/04ISR Number: 4483529-XReport Type:Direct Age:63 YR Gender:Female I/FU:I Outcome Dose Other INTRATHECAL PT Company Report #CTU 230115 Report Source Product Role Baclofen PS Manufacturer Route Duration Convulsion 75 MG ONCE IT Respiratory Distress Date:10/25/04ISR Number: 4483836-0Report Type:Expedited (15-DaCompany Report #PHRM2004FR03161 Age:13 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Pancreatitis Initial or Prolonged 10 mg, TID 1460 DAY Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Depakine SS ORAL Theralene SS ORAL Smecta Duphalac Efferalgan Mopral SS SS C C ORAL ORAL ORAL ORAL 500 mg, TID 10 mg, QD 365 DAY 10 mg, QD Date:10/25/04ISR Number: 4485343-8Report Type:Direct Age:44 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATRACHEAL PT Dysarthria Lethargy Company Report #CTU 230381 Report Source Product Role Manufacturer Lioresal Intrathecal 2000mcg/Ml Medtrinoc PS Medtrinoc INTRATRACH Date:10/25/04ISR Number: 4487674-4Report Type:Expedited (15-DaCompany Report #20042026 Age: Gender:Male I/FU:I Route Outcome PT Dose Duration Hospitalization Catheter Related Initial or Prolonged Infection INTRATHECAL MCG, DAILY, Csf Culture Positive INTRATHECAL Lung Infection Meningitis Staphylococcal Infection White Blood Cell Count Increased Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Date:10/26/04ISR Number: 4488597-7Report Type:Expedited (15-DaCompany Report #20042018 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Catheter Related Initial or Prolonged Infection INTRATHECAL DAILY, Implant Site Infection INTRATHECAL Meningitis Staphylococcal Infection Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Date:10/28/04ISR Number: 4488183-9Report Type:Expedited (15-DaCompany Report #PHNU2004DE03651 Age:58 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 246 12:15 PM PT Bradycardia Bradypnoea FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypotonia Intentional Misuse Loss Of Consciousness Dose Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Manufacturer Route Manufacturer Route Duration Myoclonic Epilepsy Sopor 15 DF, ONCE/SINGLE 1440 MIN Date:10/29/04ISR Number: 4492023-1Report Type:Expedited (15-DaCompany Report #PHNU2004DE03427 Age:43 YR Gender:Female I/FU:I Outcome Dose INTRATHECAL PT Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen) Unknown PS Other Beta Blocking Agents (No Ingredients/Substanc es) C Duration Drug Withdrawal Syndrome Medication Error 750 NG, QD Pyrexia Date:11/01/04ISR Number: 4491269-6Report Type:Direct Age:22.5 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 40 MG PO Q 6 Required H [2 DOSES] Intervention to 1.5 MG PO Q6 Prevent Permanent H [2 DOSES] Impairment/Damage PT Apnoea Company Report #CTU 230853 Report Source Product Role Baclofen PS ORAL Clonazepam SS ORAL Oxygen Saturation Decreased Procedural Complication Respiratory Depression Scar Date:11/01/04ISR Number: 4492086-3Report Type:Expedited (15-DaCompany Report #2004081136 Age: Gender:Unknown I/FU:I Outcome Dose Other 22-Aug-2005 Page: 247 PT Report Source Product Diabetes Mellitus Fibromyalgia Multiple Sclerosis Consumer Neurontin (Gabapentin) Fentanyl (Fentanyl) Oxycocet (Oxycodone Hydrochloride, Paracetamol) Lidocaine (Lidocaine) Baclofen (Baclofen) Amantadine Hydrochloride (Amantadine Hydrochloride) All Other Therapeutic Proudcts (All Other Therapeutic Products) Insulin (Insulin) Role Duration 12:15 PM PS SS SS SS SS SS SS SS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/02/04ISR Number: 4492884-6Report Type:Expedited (15-DaCompany Report #PHBS2004NO12570 Age:26 YR Gender:Female I/FU:F Outcome PT Dose Duration Hospitalization Decreased Appetite Initial or Prolonged Device Failure INTRATHECAL SEE IMAGE Dyskinesia Muscle Spasticity Pyrexia Rash Generalised Rash Pruritic Respiratory Rate Decreased Sleep Disorder Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen) Ampoule PS Other Rivotril (Clonazepam) Tablet SS Manufacturer Route Manufacturer Route Manufacturer Route Date:11/02/04ISR Number: 4493386-3Report Type:Expedited (15-DaCompany Report #20042048 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Clonus Initial or Prolonged Convulsion INTRATHECAL DAILY, Hyperhidrosis INTRATHECAL Intestinal Obstruction Medication Error Muscle Spasms Pyrexia Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Date:11/05/04ISR Number: 4498419-6Report Type:Expedited (15-DaCompany Report #2004083821 Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 1200 MG (1 PT Report Source Product Role Blood Glucose Fluctuation Diabetes Mellitus Foreign Health Neurontin (Gabapentin) PS Dizziness Professional D), ORAL Drug Ineffective Lisinopril ORAL Drug Interaction (Lisinopril) SS Fall Grand Mal Convulsion Hypoglycaemia Hydrochlorothiazide (Hydrochlorothiazide ) SS Status Epilepticus Baclofen (Baclofen) SS Pantoprazole Sodium (Pantoprazole Sodium) SS Interferon Beta (Interferon Beta) SS 20 MG (1 D) 12.5 MG (1 D) 5 MG (1 D) 20 MG (1 D) SUBCUTANEOUS 1 AMPULE (2 D), SUBCUTANEOUS Amitriptyline Hydrochloride (Amitriptyline Hydrochloride) Carbamazepine (Carbamazepine) Zopiclone (Zopiclone) 22-Aug-2005 Page: 248 12:15 PM C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/10/04ISR Number: 4500929-XReport Type:Expedited (15-DaCompany Report #20042061 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL PT Report Source Product Role Meningitis Health Professional Lioresal Intrathecal(Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route MCG, DAILY, INTRACHECAL Date:11/11/04ISR Number: 4499277-6Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908837 Age:51 YR Gender:Female I/FU:I Outcome Dose Duration Death OROPHARINGEAL PT Report Source Product Role Blood Pressure Abnormal Tylenol 3 PS Cardio-Respiratory Arrest Coma Acetaminophen/Hydroc odone SS Completed Suicide Heart Rate Increased Acetaminophen/Hydroc odone SS Intentional Misuse Amitriptyline SS Loss Of Consciousness Oxygen Saturation Decreased Pupil Fixed Status Epilepticus Baclofen Zolpidem Valdecoxib Escitalopram Fentanyl Orphenadrine Pantoprazole SS SS SS SS SS SS SS OROPHARINGEAL OROPHARINGEAL OROPHARINGEAL Date:11/11/04ISR Number: 4499278-8Report Type:Expedited (15-DaCompany Report #US-JNJFOC-20040908836 Age:61 YR Gender:Female I/FU:I Outcome Dose Duration Death OROPHARINGEAL PT Apnoea Report Source Product Role Tylenol 3 PS Blood Pressure Increased Morphine SS Coma Lorazepam SS Completed Suicide Heart Rate Increased Hypothermia Intentional Misuse Miosis Pulse Absent Respiratory Rate Increased Baclofen Ibuprofen Antacid Aluminum Magnesium Hydroxide Cocaine SS SS OROPHARINGEAL OROPHARINGEAL SS SS Date:11/16/04ISR Number: 4501993-4Report Type:Expedited (15-DaCompany Report #PHHO2004AU04534 Age:29 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 600 mg, QD 397 PT Encephalopathy Loss Of Consciousness Metabolic Encephalopathy DAY Pneumonia Aspiration Sepsis Somnolence 22-Aug-2005 Page: 249 12:15 PM Report Source Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Glivec SS Route ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/17/04ISR Number: 4506997-3Report Type:Expedited (15-DaCompany Report #2004-BP-11398YA Age:41 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 0.2 MG PO PT Report Source Product Role Manufacturer Route Alanine Aminotransferase Increased Foreign Health Harnal (Tamsulosin) PS ORAL Aspartate Aminotransferase Professional Other Dantrium (Dantrolene Sodium) SS ORAL Increased Blood Bilirubin Increased Lioresal (Dantrolene Sodium) SS ORAL Blood Lactate Dehydrogenase Increased Ternelin (Tizanidine Hydrochloride) SS ORAL Gamma-Glutamyltransferase Increased Hepatic Function Abnormal Vitamedin (Benfotiamine/B6/B12 ) Diazepam (Diazepam) C C ORAL 25 MG PO 5 MG PO 1 MG PO Date:11/22/04ISR Number: 4506572-0Report Type:Expedited (15-DaCompany Report #PHRM2004FR03161 Age:13 YR Gender:Female I/FU:F Outcome PT Dose Duration Hospitalization Abdominal Distension Initial or Prolonged Blood Amylase Increased 10 mg, TID 1460 DAY C-Reactive Protein 500 mg, TID Increased 10 mg, QD 365 DAY General Physical Health Deterioration Leukocytosis Lipase Increased 10 mg, QD Pancreatic Necrosis Pancreatitis Pyrexia Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Depakine SS ORAL Theralene SS ORAL Smecta Duphalac Efferalgan Mopral SS SS C C ORAL ORAL ORAL ORAL Date:11/29/04ISR Number: 4514790-0Report Type:Direct Age:77 YR Gender:Male I/FU:I Outcome Dose Other PT Company Report #CTU 233075 Report Source Product Role Baclofen PS Manufacturer Route Duration Asthenia Confusional State Hypotension Date:11/30/04ISR Number: 4512867-7Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-04P-056-0279415-00 Age:13 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 4 YR .05% Syrup 1 PT Report Source Product Role Manufacturer Route General Physical Health Deterioration Depakine Tablets Baclofen PS SS ORAL ORAL Pancreatitis Alimemazine Tartrate SS ORAL Smectite SS ORAL Omeprazole Omeprazole C C ORAL Paracetamol Paracetamol C C ORAL Paracetamol Lactulose Phenobarbital C C C ORAL ORAL YR Powder INTRAVENOUS INTRAVENOUS 22-Aug-2005 Page: 250 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:11/30/04ISR Number: 4513292-5Report Type:Expedited (15-DaCompany Report #PHBS2004NL15786 Age:64 YR Gender:Female I/FU:I Outcome Dose Duration Death Hospitalization Initial or Prolonged PT Report Source Aortic Occlusion Hepatic Encephalopathy Hepatic Enzyme Increased Nausea Somnolence Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Nitrofuranaoine Acenocoumarol Paracetamol Simvastatin Paroxetin SS C C C C Date:12/06/04ISR Number: 4519660-XReport Type:Expedited (15-DaCompany Report #PHFR2004GB04326 Age:51 YR Gender:Female I/FU:I Outcome Dose Other 10 mg, BID PT Report Source Product Role Manufacturer Route Baclofen PS Novartis Sector: Pharma ORAL Duration Periorbital Oedema 5760 MIN Pregabalin SS Trazodone C Tramadol C Cetirizine C Omeprazole C Lactulose C Naproxen C Gabapentin C Nefopam C 75 mg, BID UNKNOWN 350mg nocte UNKNOWN 50 mg, TID UNKNOWN UNKNOWN 20mg/day UNKNOWN 15ml nocte UNKNOWN 1-2 bid 300 mg, TID UNKNOWN 600 mg, TID Date:12/06/04ISR Number: 4519688-XReport Type:Expedited (15-DaCompany Report #PHNU2004DE03876 Age:74 YR Gender:Male I/FU:F ORAL Outcome Dose Other 10mg/day PT Report Source Product Role Manufacturer Route Cerebrovascular Accident Communication Disorder Lioresal PS Novartis Sector: Pharma ORAL Disturbance In Attention Speech Disorder Mst Neurontin Tetra-Saar Saroten "Bayer Vital" Route Duration 4320 MIN C C C C Date:12/08/04ISR Number: 4521297-3Report Type:Expedited (15-DaCompany Report #PHBS2004US16080 Age:73 YR Gender:Male I/FU:I Outcome Dose Other INTRATHECAL INTRATHECAL PT Report Source Product Role Manufacturer Lioresal Intrathecal PS Novartis Sector: Pharma Lioresal Intrathecal SS Novartis Sector: Pharma Duration Catheter Related Complication 1985 mcg/day Drug Ineffective 270 mcg/day Date:12/08/04ISR Number: 4521298-5Report Type:Expedited (15-DaCompany Report #PHBS2004US16083 Age:50 YR Gender:Male I/FU:I Outcome Other 22-Aug-2005 Page: 251 PT Chills Device Failure Diarrhoea Dysgeusia Hyperhidrosis 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lacrimation Increased Nausea Pain Dose INTRATHECAL Report Source Product Role Manufacturer Lioresal Intrathecal PS Novartis Sector: Pharma Morphine C Route Duration Parosmia Yawning 129.6 ug/day Date:12/08/04ISR Number: 4521299-7Report Type:Expedited (15-DaCompany Report #PHBS2004US16084 Age: Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Lioresal Intrathecal PS Novartis Sector: Pharma Product Role Manufacturer Lioresal Intrathecal PS Novartis Sector: Pharma Product Role Manufacturer Lioresal Intrathecal PS Novartis Sector: Pharma Route Duration Hypertonia Speech Disorder INTRATHECAL Date:12/08/04ISR Number: 4521303-6Report Type:Expedited (15-DaCompany Report #PHBS2004US16086 Age: Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Route Duration Device Failure Drug Withdrawal Syndrome INTRATHECAL Date:12/08/04ISR Number: 4521304-8Report Type:Expedited (15-DaCompany Report #PHBS2004US16088 Age:49 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Duration Anxiety Hyperhidrosis INTRATHECAL Irritability Muscle Spasticity Route Date:12/09/04ISR Number: 4522627-9Report Type:Expedited (15-DaCompany Report #PHHO2004AU04534 Age:29 YR Gender:Male I/FU:F Outcome PT Dose Duration Hospitalization Coma 600 mg, QD 397 DAY Initial or Prolonged Encephalopathy Loss Of Consciousness Pneumonia Aspiration Sepsis Somnolence Report Source Product Role Health Glivec PS Professional Clofen SS Manufacturer Route ORAL Date:12/13/04ISR Number: 4525886-1Report Type:Expedited (15-DaCompany Report #PHNU2004DE04093 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Condition Aggravated Confusional State Lioresal PS Novartis Sector: Pharma ORAL Nausea Vomiting Lioresal Novartis Sector: Pharma ORAL Duration 5 mg, BID SS 2.5 mg, BID Trileptal "Novartis" 900mg/day 22-Aug-2005 Page: 252 12:15 PM C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/13/04ISR Number: 4525888-5Report Type:Expedited (15-DaCompany Report #PHBS2004PL16417 Age:40 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Acute Respiratory Failure Initial or Prolonged Blood Creatine UNKNOWN 1500 mg/day Phosphokinase Increased Bradycardia Coma Hypertension Intentional Misuse Suicide Attempt Report Source Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Route Date:12/13/04ISR Number: 4525895-2Report Type:Expedited (15-DaCompany Report #PHBS2004PL16419 Age:19 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Acute Respiratory Failure Initial or Prolonged Blood Creatine UNKNOWN 500 mg/day Phosphokinase Increased Bradycardia Coma Hypertension Intentional Misuse Suicide Attempt Report Source Route Date:12/13/04ISR Number: 4525898-8Report Type:Expedited (15-DaCompany Report #PHBS2004PL16418 Age:16 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Acute Respiratory Failure Initial or Prolonged Blood Creatine UNKNOWN 1250 mg/day Phosphokinase Increased Bradycardia Coma Intentional Misuse Suicide Attempt Report Source Route Date:12/14/04ISR Number: 4526300-2Report Type:Expedited (15-DaCompany Report #PHBS2004PL16420 Age:18 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Acute Respiratory Failure Initial or Prolonged Bradycardia UNKNOWN 400 mg/day Coma Intentional Misuse Suicide Attempt Report Source Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Date:12/14/04ISR Number: 4526301-4Report Type:Expedited (15-DaCompany Report #PHBS2004PL16422 Age:41 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 253 12:15 PM PT Acute Respiratory Failure Blood Creatine Phosphokinase Increased Coma Hypertension Intentional Misuse Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Suicide Attempt Report Source Dose UNKNOWN Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Route Duration 300 mg/day Date:12/14/04ISR Number: 4526304-XReport Type:Expedited (15-DaCompany Report #PHBS2004PL16423 Age:15 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Coma Initial or Prolonged Intentional Misuse UNKNOWN 250 mg/day Suicide Attempt Report Source Route Date:12/14/04ISR Number: 4526314-2Report Type:Expedited (15-DaCompany Report #PHBS2004PL16424 Age:55 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Acute Respiratory Failure Initial or Prolonged Blood Creatine UNKNOWN 250 mg/day Phosphokinase Increased Coma Intentional Misuse Suicide Attempt Report Source Route Date:12/14/04ISR Number: 4526315-4Report Type:Expedited (15-DaCompany Report #PHBS2004PL16431 Age:28 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Blood Creatine Initial or Prolonged Phosphokinase Increased UNKNOWN 200 mg/day Coma Intentional Misuse Report Source Route Suicide Attempt Date:12/14/04ISR Number: 4526316-6Report Type:Expedited (15-DaCompany Report #PHBS2004PL16430 Age:16 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Coma Initial or Prolonged Intentional Misuse UNKNOWN 240 mg/day Suicide Attempt Report Source Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Route Date:12/14/04ISR Number: 4526317-8Report Type:Expedited (15-DaCompany Report #PHBS2004PL16433 Age:25 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Blood Creatine Initial or Prolonged Phosphokinase Increased UNKNOWN 200 mg/day Coma Intentional Misuse Suicide Attempt 22-Aug-2005 Page: 254 12:15 PM Report Source Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/14/04ISR Number: 4528903-8Report Type:Expedited (15-DaCompany Report #20042095 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL PT Asthenia Lethargy Mental Status Changes 524.7 MCG, Pyrexia Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) 2000mcg/Ml PS Manufacturer Route Route DAILY, INTRATHECAL Date:12/15/04ISR Number: 4527203-XReport Type:Expedited (15-DaCompany Report #PHBS2004PL16435 Age:30 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Blood Creatine Initial or Prolonged Phosphokinase Increased UNKNOWN 200 mg/day Coma Hypertension Intentional Misuse Suicide Attempt Therapeutic Agent Toxicity Report Source Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Date:12/15/04ISR Number: 4527204-1Report Type:Expedited (15-DaCompany Report #PHBS2004PL16436 Age:48 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Acute Respiratory Failure Initial or Prolonged Blood Creatine UNKNOWN 200 mg/day Phosphokinase Increased Bradycardia Coma Hypotension Intentional Misuse Suicide Attempt Report Source Route Therapeutic Agent Toxicity Date:12/15/04ISR Number: 4527206-5Report Type:Expedited (15-DaCompany Report #PHBS2004PL16437 Age:48 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Acute Respiratory Failure Initial or Prolonged Blood Creatine UNKNOWN 200 mg/day Phosphokinase Increased Coma Intentional Misuse Suicide Attempt Report Source Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Date:12/15/04ISR Number: 4527208-9Report Type:Expedited (15-DaCompany Report #PHBS2004PL16438 Age:53 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 255 12:15 PM PT Acute Respiratory Failure Blood Creatine Phosphokinase Increased Bradycardia Coma Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Intentional Misuse Suicide Attempt Report Source Dose UNKNOWN Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Route Duration 200 mg/day Date:12/15/04ISR Number: 4527209-0Report Type:Expedited (15-DaCompany Report #PHBS2004PL16439 Age:21 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Coma Initial or Prolonged Intentional Misuse UNKNOWN 150 mg/day Suicide Attempt Report Source Route Date:12/15/04ISR Number: 4527210-7Report Type:Expedited (15-DaCompany Report #PHBS2004PL16440 Age:58 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Blood Creatine Initial or Prolonged Phosphokinase Increased UNKNOWN 150 mg/day Bradycardia Coma Hypertension Intentional Misuse Suicide Attempt Report Source Route Date:12/15/04ISR Number: 4527211-9Report Type:Expedited (15-DaCompany Report #PHBS2004PL16443 Age:48 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged UNKNOWN PT Acute Respiratory Failure Blood Creatine Phosphokinase Increased Report Source Route Coma Hypertension Intentional Misuse Suicide Attempt Date:12/15/04ISR Number: 4527216-8Report Type:Expedited (15-DaCompany Report #PHRM2004FR03660 Age:34 YR Gender:Female I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 300 mg, Initial or Prolonged ONCE/SINGLE PT Bradycardia Coma Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Intentional Misuse Mydriasis Suicide Attempt Date:12/15/04ISR Number: 4527520-3Report Type:Expedited (15-DaCompany Report #PHBS2004PL16421 Age:19 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 256 12:15 PM PT Blood Creatine Phosphokinase Increased Coma Intentional Misuse FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Psychotic Disorder Suicide Attempt Report Source Dose UNKNOWN Product Role Manufacturer Route Baclofen PS Novartis Sector: Pharma Product Role Manufacturer Route Ammonia Increased Depressed Level Of Lioresal PS Novartis Sector: Pharma ORAL Consciousness Gamma-Glutamyltransferase Increased Hepatic Enzyme Increased Hepatocellular Damage Tetrazepam Antibiotics Heparin Manufacturer Route Route Duration 400 mg/day Date:12/16/04ISR Number: 4528559-4Report Type:Expedited (15-DaCompany Report #PHNU2004DE04185 Age: Gender:Male I/FU:I Outcome Dose Other PT Report Source Duration 10 mg, TID C C C Date:12/20/04ISR Number: 4535940-6Report Type:Expedited (15-DaCompany Report #20042105 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Meningitis Initial or Prolonged INTRATHECAL MCG, DAILY, Other INTRATHECAL Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Date:12/21/04ISR Number: 4532668-3Report Type:Expedited (15-DaCompany Report #PHRM2004FR03639 Age:55 YR Gender:Female I/FU:I Outcome Dose Other 200 mg, BID PT Report Source Product Role Manufacturer Tegretol PS Novartis Sector: Pharma Duration Abasia Drug Interaction Facial Palsy Lioresal SS ORAL Date:12/21/04ISR Number: 4532686-5Report Type:Expedited (15-DaCompany Report #PHRM2004FR03670 Age:53 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 30 mg, TID PT Report Source Product Role Manufacturer Route Arthritis Convulsion Lioresal PS Novartis Sector: Pharma ORAL Pneumonia Aspiration Athymil SS Sepsis Subileus Lioresal SS ORAL 60 mg/day Novartis Sector: Pharma ORAL 60 mg/day Urbanyl Keppra Imovane C C C ORAL ORAL ORAL Rifadine C ORAL Bactrim Forte C Lovenox Tazocilline C C Ciflox C Perfalgan C 7.5 mg, QD 600 mg, BID INTRAVENOUS INTRAVENOUS UNKNOWN INTRAVENOUS 22-Aug-2005 Page: 257 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:12/23/04ISR Number: 4535895-4Report Type:Expedited (15-DaCompany Report #PHNU2003DE02314 Age:68 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 25 mg, QD PT Report Source Product Role Manufacturer Route Dizziness Drug Interaction Esidrix PS Novartis Sector: Pharma ORAL Eye Rolling Baclofen SS ORAL Fall Benalapril SS ORAL Hypotension Orthostatic Hypotension Benalapril Doxepin (Ngx) SS SS ORAL Tremor Celebrex C ORAL Metoclopramide C ORAL 25 mg, UNK 5 mg, QD 75 mg, QD 200 mg, PRN 30 gtt, PRN Date:12/29/04ISR Number: 4542809-XReport Type:Expedited (15-DaCompany Report #2004-05265 Age:38 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization SEE IMAGE Initial or Prolonged Other PT Report Source Product Role Manufacturer Route Condition Aggravated Consumer Baclofen PS Watson Labaoratories ORAL Nexium (Esomeprazole) Multivitamins C C Manufacturer Route Drug Ineffective For Unapproved Indication Muscle Spasticity Nephrolithiasis Paraesthesia Date:01/03/05ISR Number: 4544097-7Report Type:Expedited (15-DaCompany Report #PHNU2003DE02314 Age:68 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 25 MG, QD, ORAL PT Report Source Product Role Dizziness Drug Interaction Foreign Study Esidrix(Hydrochlorot hiazide) Tablet PS Drug Interaction Health ORAL Potentiation Eye Rolling Professional Other Baclofen (Baclofen, Baclofen) SS ORAL Benalapril (Enalapril) Tablet, 5mg SS ORAL Doxepin (Ngx) (Doxepin) Capsule SS ORAL 25 MG, ORAL Fall Orthostatic Hypotension Tremor 5 MG, QD, ORAL 75 MG, QD, ORAL Celebrex (Celecoxib) Capsule Metoclopramide (Metoclopramide) Solution C C Date:01/06/05ISR Number: 4546300-6Report Type:Expedited (15-DaCompany Report #PHBS2002CL09569 Age:41 YR Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Abdominal Distension Abdominal Pain Lioresal PS Novartis Sector: Pharma ORAL Abdominal Pain Upper Chest Wall Pain Lioresal Novartis Sector: Pharma ORAL Fatigue Flatulence Lioresal Novartis Sector: Pharma ORAL Haematochezia Somnolence Lioresal Novartis Sector: Pharma ORAL Urinary Incontinence Diazepam Duration 1 tablet/day SS 2 tablets/day SS 4 tablets/day SS 20 mg/day UNKNOWN 22-Aug-2005 Page: 258 12:15 PM C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Losec UNKNOWN Date:01/07/05ISR Number: 4624543-0Report Type:Periodic Age:53 YR Gender:Female I/FU:I Outcome Dose C PRN Company Report #234705K04USA PT Report Source Product Role Joint Swelling Oedema Peripheral Consumer Rebif (Interferon Beta) Baclofen PS SS Manufacturer Route Route Duration Date:01/13/05ISR Number: 4552753-XReport Type:Direct Age:17 YR Gender:Male I/FU:I Outcome PT Dose Duration Life-Threatening Catheter Related Hospitalization Complication Initial or Prolonged Device Failure INTRATHECAL 400 MCG Required Drug Withdrawal Syndrome DAILY Intervention to Surgery INTRATHECA Prevent Permanent Impairment/Damage Date:01/18/05ISR Number: 4555354-2Report Type:Direct Age:35 YR Gender:Female I/FU:I Outcome PT Dose Duration Other Blood Glucose Decreased SUBCUTANEOUS 66 UNITS OVER Drug Interaction 24 HOURS Company Report #CTU 236599 Report Source Product Role Manufacturer Intrathecal Baclofen Pump 400 Mcg Per Day Medtronics PS Medtronics Product Role Manufacturer Novolog Novonordisk PS Novonordisk Baclofen 10mg SS Company Report #CTU 237033 Report Source Route SUBCUTANEOUS 10MG TID ORAL ORAL Date:01/18/05ISR Number: 4557689-6Report Type:Expedited (15-DaCompany Report #PHFR2004GB04658 Age: Gender: I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Coma Escherichia Infection Incoherent Pyrexia Therapy Non-Responder Health Professional Other Lioresal (Baclofen) Solution For Injection PS Manufacturer Route Route Date:01/19/05ISR Number: 4555426-2Report Type:Expedited (15-DaCompany Report #PHBS2005US00800 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Arnold-Chiari Initial or Prolonged Malformation UNKNOWN 300 mg/day Brain Herniation INTRATHECAL Drooling Dysarthria Facial Palsy Hypokinesia Joint Contracture Shunt Malfunction Surgery 22-Aug-2005 Page: 259 12:15 PM Report Source Product Role Manufacturer Tegretol PS Novartis Sector: Pharma Baclofen Intrathecal SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/19/05ISR Number: 4556071-5Report Type:Expedited (15-DaCompany Report #PHBS2005IE00673 Age: Gender:Unknown I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Duration Mania Date:01/19/05ISR Number: 4556072-7Report Type:Expedited (15-DaCompany Report #PHRM2005FR00544 Age:42 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization 50 mg/day Initial or Prolonged 117 DAY 1 DF, BID 300 PT Report Source Product Role Manufacturer Route Alanine Aminotransferase Increased Lioresal PS Novartis Sector: Pharma ORAL Aspartate Bactrim Forte SS ORAL Aminotransferase Increased Viracept "Roche" Combivir SS SS ORAL ORAL Blood Lactate Lysanxia SS ORAL Dehydrogenase Increased Fumafer SS ORAL Bone Marrow Depression Depakine Chrono SS ORAL Prothrombin Level Coversyl SS ORAL Decreased Aspegic C ORAL DAY 10080MIN 10080MIN 500 mg, BID 214 DAY 4 mg/day Date:01/19/05ISR Number: 4558591-6Report Type:Expedited (15-DaCompany Report #2004056018 Age: Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Abnormal Behaviour Adverse Event Amnesia Economic Problem Feeling Hot Granuloma Heart Rate Increased Consumer Health Professional Neurontin (Gabapentin) Morphine (Morphine) All Other Non-Therapeutic Products (All Other Non-Therapeutic Role Duration PS SS Manufacturer Route Hot Flush Hyperhidrosis Inadequate Analgesia Insomnia Loss Of Consciousness Medical Device Complication Nerve Injury Oedema Pain Speech Disorder Spinal Disorder Weight Increased Products) Baclofen (Baclofen) Date:01/21/05ISR Number: 4578905-0Report Type:Periodic Age:9 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL 22-Aug-2005 Page: 260 Company Report #PHBS2003US13735 PT Report Source Product Role Muscle Spasticity Health Professional Liorseal Intrathecal $Me(Baclofen) Ampoule PS INTRATHECAL 12:15 PM SS SS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/05ISR Number: 4578906-2Report Type:Periodic Age:44 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATRACHEAL PT Report Source Product Role Meningitis Pyrexia Swelling INTRATHECAL Health Professional Liorseal Intrathecal $Me(Baclofen) Ampoule PS Date:01/21/05ISR Number: 4578909-8Report Type:Periodic Age:65 YR Gender:Female I/FU:I Outcome Dose Other INTRATHECAL PT Confusional State Drug Ineffective Drug Withdrawal Syndrome INTRATHECAL Hypertonia Pruritus Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL Route Manufacturer Route Manufacturer Route Manufacturer Route Company Report #PHBS2004US01509 Report Source Product Role Health Professional Liorseal Intrathecal $Me(Baclofen) Ampoule PS PT Cerebrospinal Fluid Leakage Muscle Spasticity INTRATHECAL Company Report #PHBS2004US07423 Report Source Product Role Health Professional Liorseal Intrathecal $Me(Baclofen) Ampoule PS Date:01/21/05ISR Number: 4578912-8Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Manufacturer Duration Date:01/21/05ISR Number: 4578911-6Report Type:Periodic Age:40 YR Gender:Male I/FU:I INTRATHECAL Company Report #PHBS2004US01505 Company Report #PHBS2004US07475 PT Report Source Product Role Drug Ineffective Health Professional Lioresal Intrathecal $Me(Baclofen) Ampoule PS Duration INTRATHECAL Date:01/21/05ISR Number: 4578913-XReport Type:Periodic Age:45 YR Gender:Male I/FU:I Outcome Dose Other INTRATHECAL PT Report Source Product Role Muscle Spasticity Health Professional Lioresal Intrathecal $Me(Baclofen) Ampoule PS Route Manufacturer Route INTRATHECAL Outcome Dose Duration Hospitalization Initial or Prolonged Company Report #PHBS2004US07483 PT Report Source Product Role Muscle Spasticity Health Professional Lioresal Intrathecal $Me(Baclofen) Ampoule PS INTRATHECAL Date:01/21/05ISR Number: 4578918-9Report Type:Periodic Age:16 YR Gender:Female I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 261 Manufacturer Duration Date:01/21/05ISR Number: 4578916-5Report Type:Periodic Age:24 YR Gender:Male I/FU:I INTRATHECAL Company Report #PHBS2004US07476 12:15 PM PT Muscle Spasticity Musculoskeletal Stiffness Company Report #PHBS2004US07485 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Pruritus Dose INTRATHECAL Report Source Product Role Health Professional Lioresal Intrathecal $Me(Baclofen) Ampoule PS INTRATHECAL PT Confusional State Convulsion Headache INTRATHECAL Hypertonia Hypotension Infection Pruritus Urinary Tract Infection Outcome Dose Duration Hospitalization Initial or Prolonged Report Source Product Role Health Professional Lioresal Intrathecal $Me(Baclofen) Ampoule PS Tegretol (Carbamazepine) Valium (Diazepam) Demerol (Pethidine Hydrochloride) PT Route Manufacturer Route Condition Aggravated Hypertonia Muscle Spasticity INTRATHECAL Pain Manufacturer Route C C C Company Report #PHBS2004US08489 Report Source Product Role Health Professional Lioresal Intrathecal $Me(Baclofen) Ampoule PS Date:01/21/05ISR Number: 4578921-9Report Type:Periodic Age:47 YR Gender:Female I/FU:I Outcome Dose Other Manufacturer Company Report #PHBS2004US07572 Duration Date:01/21/05ISR Number: 4578920-7Report Type:Periodic Age:34 YR Gender:Female I/FU:I INTRATHECAL Route INTRATHECAL Date:01/21/05ISR Number: 4578919-0Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Manufacturer Duration Company Report #PHBS2004US08491 PT Report Source Product Hypertonia Health Lioresal Intrathecal Duration Role Professional INTRATHECAL Outcome Dose Duration Hospitalization Initial or Prolonged 22-Aug-2005 Page: 262 Company Report #PHBS2004US08492 PT Report Source Product Role Hypertonia Muscle Rigidity Health Professional Lioresal Intrathecal &Me(Baclofen) Ampoule PS Manufacturer Route Manufacturer Route Duration Date:01/21/05ISR Number: 4578923-2Report Type:Periodic Age:68 YR Gender:Male I/FU:I INTRATHECAL PS INTRATHECAL Date:01/21/05ISR Number: 4578922-0Report Type:Periodic Age:10 YR Gender:Male I/FU:I Outcome Dose Other $Me (Baclofen) Ampoule PT Report Source Product Role Drug Ineffective Muscle Spasticity Health Professional Lioresal Intrathecal &Me(Baclofen) Ampoule PS INTRATHECAL 12:15 PM Company Report #PHBS2004US08555 FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/05ISR Number: 4578924-4Report Type:Periodic Age:14 YR Gender:Female I/FU:I Outcome Dose Other INTRATHECAL PT Report Source Product Role Overdose Respiratory Distress Health Professional Lioresal Intrathecal &Me(Baclofen) Ampoule PS Route Manufacturer Route Manufacturer Route Manufacturer Route INTRATHECAL Outcome PT Dose Duration Hospitalization Drug Ineffective Initial or Prolonged Muscle Spasticity INTRATHECAL INTRATHECAL Outcome PT Dose Duration Hospitalization Drug Ineffective Initial or Prolonged Muscle Spasticity INTRATHECAL INTRATHECAL Product Role Health Professional Lioresal Inthratecal (Baclofen) Ampoule PS Company Report #PHBS2004US08720 Report Source Product Role Health Professional Lioresal Inthratecal (Baclofen) Ampoule PS Date:01/21/05ISR Number: 4578927-XReport Type:Periodic Age:50 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Company Report #PHBS2004US08719 Report Source Date:01/21/05ISR Number: 4578926-8Report Type:Periodic Age:46 YR Gender:Male I/FU:I INTRATHECAL Manufacturer Duration Date:01/21/05ISR Number: 4578925-6Report Type:Periodic Age:47 YR Gender:Male I/FU:I INTRATHECAL Company Report #PHBS2004US08645 Company Report #PHBS2004US08811 PT Report Source Product Role Drug Ineffective Health Professional Lioresal Intrathecal &Me(Baclofen) Ampoule PS 200 UG/DAY, Date:01/21/05ISR Number: 4578928-1Report Type:Periodic Age:32 YR Gender:Female I/FU:I Outcome Dose Other INTRATHECAL PT Report Source Product Role Hypotonia Health Professional Lioresal Intrathecal &Me(Baclofen) Ampoule PS INTRATHECAL INTRATHECAL 22-Aug-2005 Page: 263 Route Manufacturer Route Manufacturer Route INTRATHECAL Company Report #PHBS2004US08961 PT Report Source Product Role Muscle Spasticity Health Professional Lioresal Intrathecal &Me(Baclofen) Ampoule PS Duration INTRATHECAL Date:01/21/05ISR Number: 4578930-XReport Type:Periodic Age:23 YR Gender:Female I/FU:I Outcome Dose Other Manufacturer Duration Date:01/21/05ISR Number: 4578929-3Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #PHBS2004US08958 Company Report #PHBS2004US08965 PT Report Source Product Role Dizziness Overdose Health Professional Lioresal Intrathecal &Me(Baclofen) Ampoule PS Duration INTRATHECAL 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/05ISR Number: 4578931-1Report Type:Periodic Age:44 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Condition Aggravated Initial or Prolonged Muscle Spasms INTRATHECAL INTRATHECAL Pain Report Source Product Role Health Professional Lioresal Intratecal (Baclofen) Ampoule PS Date:01/21/05ISR Number: 4578932-3Report Type:Periodic Age:11 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Lethargy Initial or Prolonged Overdose INTRATHECAL INTRATHECAL Vomiting INTRATHECAL Product Role Health Professional Lioresal Intrathecal (Baclofen) Ampoule PS INTRATHECAL Route Manufacturer Route Manufacturer Route Manufacturer Route Company Report #PHBS2004US09253 PT Report Source Product Role Drug Ineffective Health Professional Lioresal Intrathecal $Me(Baclofen) Ampoule PS Duration INTRATHECAL Date:01/21/05ISR Number: 4578935-9Report Type:Periodic Age:61 YR Gender:Male I/FU:I Outcome Dose Other Manufacturer Company Report #PHBS2004US09118 Report Source Date:01/21/05ISR Number: 4578933-5Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #PHBS2004US09117 Company Report #PHBS2004US09254 PT Report Source Product Role Muscle Spasticity Health Professional Lioresal Intrathecal Me (Baclofen) Ampoule PS Duration INTRATHECAL Date:01/21/05ISR Number: 4578936-0Report Type:Periodic Age:47 YR Gender:Male I/FU:I Outcome Dose Other INTRATHECAL PT Report Source Product Role Health Professional Lioresal Intrathecal Me (Baclofen) Ampoule PS INTRATHECAL Drug Ineffective Overdose Sedation INTRATHECAL INTRATHECAL Manufacturer Route Manufacturer Route Company Report #PHBS2004US10137 PT Report Source Product Role Drug Ineffective Health Professional Lioresal Intrathecal Me (Baclofen) Ampoule PS INTRATHECAL Company Report #PHBS2004US10138 PT Report Source Product Role Drug Ineffective Health Professional Lioresal Intrathecal Me (Baclofen) Ampoule PS Duration 975 UG/DAY, INTRATHECAL 22-Aug-2005 Page: 264 Route Duration Date:01/21/05ISR Number: 4578944-XReport Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Manufacturer Duration Date:01/21/05ISR Number: 4578943-8Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other Company Report #PHBS2004US10136 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/21/05ISR Number: 4578945-1Report Type:Periodic Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL Company Report #PHBS2004US10139 PT Report Source Product Role Muscle Spasticity Health Professional Lioresal Intrathecal Me (Baclofen) Ampoule PS Manufacturer Route Manufacturer Route Manufacturer Route 600 UG/DAY, INTRATHECAL Clonidine Dilaudid (Hydromorphone Hydrochloride) Date:01/21/05ISR Number: 4578946-3Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other INTRATHECAL INTRATHECAL C Company Report #PHBS2004US10140 PT Report Source Product Role Drug Withdrawal Syndrome Loss Of Consciousness Health Professional Lioresal Intrathecal Me (Baclofen) Ampoule PS Dilaudid (Hydromorphone Hydrochloride) C Duration INTRATHECAL Date:01/21/05ISR Number: 4578949-9Report Type:Periodic Age: Gender:Male I/FU:I Outcome Dose Other C Company Report #PHBS2004US10141 PT Report Source Product Role Muscle Spasms Health Professional Lioresal Intrathecal Me (Baclofen) Ampoule PS Duration INTRATHECAL Date:01/26/05ISR Number: 4560776-XReport Type:Expedited (15-DaCompany Report #FR-SOLVAY-00205000157 Age:42 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Daily dose: 4 Hospitalization milligram(s) Initial or Prolonged Daily dose: PT Alanine Aminotransferase Report Source Product Role Manufacturer Route Coversyl PS ORAL Bactrim SS ORAL Combivir SS ORAL Viracept SS ORAL Depakine SS ORAL Lioresal SS Aspegic C Lysanxia C ORAL Fumafer C ORAL Increased Aspartate Aminotransferase unknown 117 DAY Increased Daily dose: 2 Blood Lactate dosage form 300 DAY Dehydrogenase Increased Daily dose: Bone Marrow Depression unknown Prothrombin Level Daily dose: Decreased 1000 milligram(s) 214 SUBCUTANEOUS DAY Daily dose: 50 milligram(s) SUBCUTANEOUS Daily dose: unknown Daily dose: unknown 0 MON Daily dose: unknown 22-Aug-2005 Page: 265 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:01/26/05ISR Number: 4561632-3Report Type:Expedited (15-DaCompany Report #FR-GLAXOSMITHKLINE-B0364763A Age:42 YR Gender:Male I/FU:I Outcome PT Dose Duration Life-Threatening Alanine Aminotransferase 1TAB Twice Other Increased per day 10 MON Anaemia Aspartate 4 MON Aminotransferase 500MG Twice Increased per day 7 MON Blood Lactate 4MG Per day Dehydrogenase Increased 50MG per day Bone Marrow Depression Leukopenia Prothrombin Level Decreased Thrombocytopenia Date:01/26/05ISR Number: 4566398-9Report Type:Direct Age:15 MON Gender:Male I/FU:I Outcome Dose Duration Life-Threatening Hospitalization Initial or Prolonged PARENTERAL 5MG PT Apnoeic Attack Coma Depressed Level Of Consciousness TID Dry Mouth Report Source Product Role Manufacturer Route Combivir PS Glaxosmithkline ORAL Viracept Bactrim Fort SS SS Glaxosmithkline ORAL ORAL Depakine Chrono SS ORAL Coversyl SS ORAL Lioresal SS ORAL Aspegic Lysanxia Fumafer C C C Glaxosmithkline ORAL ORAL ORAL Product Role Manufacturer Route Baclofen 1mg/1ml Clinical Apothecaries PS Clinical Apothecaries Valium Phenobarbital Pepcid C C C Company Report #CTU 238039 Report Source PARENTERAL Dyspnoea Dysuria Hypotonia Lethargy Mental Status Changes Moaning Oedema Peripheral Pyrexia Retching Staring Date:01/27/05ISR Number: 4562762-2Report Type:Expedited (15-DaCompany Report #PHBS2004NL15786 Age:64 YR Gender:Female I/FU:F Outcome Dose Duration Death Hospitalization Initial or Prolonged PT Report Source Aortic Occlusion Autoimmune Hepatitis Hepatic Encephalopathy Hepatic Enzyme Increased Nausea Somnolence Date:02/01/05ISR Number: 4601997-7Report Type:Periodic Age:42 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization DF Initial or Prolonged DF DF 22-Aug-2005 Page: 266 12:15 PM Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Nitrofuranaoine Acenocoumarol Paracetamol Simvastatin Paroxetin SS C C C C Manufacturer Route Company Report #ACO_0019_2004 PT Report Source Product Role Accidental Overdose Consumer Zanaflex PS Coma Baclofen SS Respiratory Distress Xanax SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/02/05ISR Number: 4578098-XReport Type:Direct Age:58 YR Gender:Male I/FU:I Outcome Dose PT Company Report #CTU 238907 Report Source Product Role Baclofen 10mg PS Manufacturer Route Duration Oedema Peripheral Date:02/07/05ISR Number: 4571548-4Report Type:Expedited (15-DaCompany Report #PHBS2003JP06722 Age:37 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Depressed Level Of Consciousness Muscular Weakness Sleep Apnoea Syndrome Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Manufacturer Route Date:02/07/05ISR Number: 4576705-9Report Type:Expedited (15-DaCompany Report #20052152 Age: Gender:Male I/FU:I Outcome PT Dose Duration Life-Threatening Convulsion Hospitalization Loss Of Consciousness INTRATHECAL MCG, DAILY, Initial or Prolonged Muscle Spasticity INTRATHECAL Required Sepsis Intervention to Treatment Noncompliance Prevent Permanent Impairment/Damage Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Oral Baclofen Iv Valium C C Date:02/08/05ISR Number: 4575062-1Report Type:Expedited (15-DaCompany Report #PERI0020500157 Age:42 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Blood Lactate 300 DAY Initial or Prolonged Dehydrogenase Increased UNKNOWN 4MG Per day Report Source Product Role Manufacturer Route Combivir PS Glaxosmithkline ORAL Coversyl SS Bone Marrow Depression Bactrim SS Prothrombin Level Viracept SS Decreased Depakine Chrono SS Transaminases Increased Lioresal SS Glaxosmithkline UNKNOWN UNKNOWN UNKNOWN UNKNOWN Date:02/09/05ISR Number: 4575417-5Report Type:Expedited (15-DaCompany Report #PHEH2005US01539 Age:42 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Alanine Aminotransferase Increased Aspartate Lioresal PS Novartis Sector: Pharma Coversyl SS Aminotransferase Increased Blood Lactate Dehydrogenase Increased Bone Marrow Depression Prothrombin Level Decreased Bactrim Viracept Combivir Depakine Chrono SS SS SS SS 4 mg, QD 22-Aug-2005 Page: 267 12:15 PM Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/09/05ISR Number: 4577751-1Report Type:Expedited (15-DaCompany Report #2004AL000561 Age:61 YR Gender:Female I/FU:F Outcome Dose Duration Death Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Blood Pressure Increased Coma Completed Suicide Heart Rate Increased Literature Health Professional Kadian (Morphine Sulfate Sustained Release) Capsules, 100 Mg (Alpharma) PS Alpharma ORAL Hypothermia Intentional Misuse Lorazepam Tablets Usp, 2 Mg (Purepac) SS Purepac ORAL Miosis Pulse Absent Respiratory Arrest Respiratory Rate Increased Capital And Codeine Oral Suspension (Acetaminophen/Codei ne Oral Suspension), 120/12 Per 5 SS Alpharma ORAL Ibuprofen Oral Suspension Usp, 100 Mg/5 Ml (Otc) (Alpharma) SS Alpharma ORAL Ibuprofen Oral Suspension Usp, 100 Mg/5 Ml (Rx) (Alpharma) SS Alpharma ORAL Baclofen SS ORAL Aluminium/Magnesioum Hydroxide SS ORAL Cocaine SS ORAL PO PO PO PO PO PO PO PO Date:02/10/05ISR Number: 4579819-2Report Type:Expedited (15-DaCompany Report #2005022833 Age:42 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening PT Report Source Product Alanine Aminotransferase Increased Foreign Health Viracept (Tablet) (Nelfinavir Role Manufacturer Route Aplastic Anaemia Professional Mesilate) PS ORAL Aspartate Aminotransferase Increased Bactrim (Sulfamethoxazole, Trimethoprim) SS ORAL Biopsy Bone Marrow Abnormal Blood Creatinine Abnormal Blood Lactate Zidovudine W/Lamivudine (Lamivudine, Zidovudine) SS ORAL Ergenyl Chrono (Valproate Sodium, Valproic Acid) SS ORAL Perindopril (Perindopril) SS ORAL Baclofen (Baclofen) SS ORAL ORAL 2 IN 1 D, Dehydrogenase Increased ORAL Prothrombin Time Shortened Treatment Noncompliance 2 IN 1 D, ORAL 4 MG (4 MG, 1 IN 1 D), ORAL Date:02/11/05ISR Number: 4578446-0Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-05P-056-0289128-00 Age:42 YR Gender:Male I/FU:I Outcome Life-Threatening 22-Aug-2005 Page: 268 12:15 PM PT Alanine Aminotransferase Increased Aspartate Aminotransferase FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Increased Blood Lactate Dehydrogenase Increased Bone Marrow Depression Dose Report Source Product Role Manufacturer Route Depakine Chrono Tablets PS ORAL Bactrim SS ORAL Nelfinavir Mesilate Nelfinavir Mesilate Nelfinavir Mesilate Nelfinavir Mesilate Zidovudine W/Lamivudine Zidovudine W/Lamivudine Perindopril Baclofen Acetylsalicylate Lysine SS SS SS SS ORAL SS ORAL SS SS SS ORAL ORAL Prazepam C ORAL Ferrous Fumarate C ORAL Duration Prothrombin Time Ratio Decreased 213 DAY 115 DAY ORAL C UNKNOWN 5 DAY 5 DAY Date:02/11/05ISR Number: 4583757-9Report Type:Expedited (15-DaCompany Report #20052173 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Drug Withdrawal Syndrome Initial or Prolonged Muscle Spasticity Required Pruritus INTRATHECAL 180 MCG, Intervention to Pyrexia DAILY, Prevent Permanent INTRATHECAL Impairment/Damage Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) 720 Mcg/Ml PS Morphine Sulfate C Manufacturer Route Date:02/11/05ISR Number: 4583845-7Report Type:Expedited (15-DaCompany Report #2005022019 Age:29 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 600 MG (200 Other MG, 3 IN 1 D) PT Report Source Product Role Cystitis Depression Consumer Neurontin (Gabapentin) PS Disturbance In Attention Drug Interaction Baclofen (Baclofen) (Baclofen) SS Hallucination Hypotension Insomnia Neuralgia Pain In Extremity Psychotic Disorder Sensory Disturbance Social Avoidant Behaviour Syncope Paracetamol Ibuprofen Vicodin (Hydrocodone Bitartrate, Paracetamol) Diarrhoea 130 MG Date:02/11/05ISR Number: 4583901-3Report Type:Expedited (15-DaCompany Report #20052158 Age: Gender:Female I/FU:I Outcome Required Intervention to Prevent Permanent 22-Aug-2005 Page: 269 12:15 PM C C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Impairment/Damage Dose INTRATHECAL PT Report Source Product Role Dysuria Medical Device Health Professional Lioresal Intrathecal (Baclofen Injection) PS Fentanyl C Manufacturer Route Duration DAILY, Complication INTRATHECAL Medication Error Muscle Spasms Neck Pain Pain Pyrexia Date:02/15/05ISR Number: 4582767-5Report Type:Expedited (15-DaCompany Report #PERI0020500157 Age:42 YR Gender:Male I/FU:F Outcome PT Dose Duration Hospitalization Alanine Aminotransferase 300 DAY Initial or Prolonged Increased UNKNOWN 4MG Per day Aspartate UNKNOWN Aminotransferase UNKNOWN Increased UNKNOWN Blood Lactate UNKNOWN Dehydrogenase Increased Bone Marrow Depression Prothrombin Level Decreased Transaminases Increased Report Source Product Role Manufacturer Route Combivir PS Glaxosmithkline ORAL Coversyl SS Bactrim SS Viracept SS Depakine Chrono SS Lioresal SS Glaxosmithkline Date:02/15/05ISR Number: 4587494-6Report Type:Expedited (15-DaCompany Report #2005024115 Age:42 YR Gender:Male I/FU:I Outcome Dose PT Duration Report Source Product Role Manufacturer Route Hospitalization Initial or Prolonged Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Health Professional Viracept (Tablet) (Nelfinavir Mesilate) Perindopril (Perindopril) PS SS 4 MG Blood Lactate Dehydrogenase Increased Bone Marrow Depression Prothrombin Level Decreased Bactrim (Sulfamethoxazole, Trimethoprim) Zidovudine W/Lamivudine (Lamivudine, Zidovudine) Ergenyl Chrono (Valproate Sodium, Valproic Acid) Baclofen (Baclofen) SS SS SS SS Date:02/16/05ISR Number: 4583868-8Report Type:Expedited (15-DaCompany Report #PHNU2005DE00955 Age:80 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Duration Depressed Level Of Consciousness 10 mg, QD (pulverized) 1440 MIN Risperdal 1 mg, QD (pulverized) 22-Aug-2005 Page: 270 1440 MIN 12:15 PM SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Durogesic C Date:02/16/05ISR Number: 4583980-3Report Type:Expedited (15-DaCompany Report #PHBS2005US02308 Age:67 YR Gender:Male I/FU:I Outcome Dose Death Other UNKNOWN PT Report Source Product Role Manufacturer Abdominal Mass Confusional State Baclofen PS Novartis Sector: Pharma Death Drug Ineffective Eructation Faecaloma Faeces Hard Haematemesis Insomnia Nausea Small Intestinal Obstruction Vomiting Chlorpromazine Metoclopramide Senna Hydromorphone Lidocaine C C C C C Route Duration Date:02/16/05ISR Number: 4588914-3Report Type:Expedited (15-DaCompany Report #2004056018 Age:41 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Abnormal Behaviour Amnesia Consumer Health Neurontin (Gabapentin) PS Professional Morphine (Morphine) SS Baclofen (Baclofen) All Other Non-Therapeutic Products (All Other Non-Therapeutic Product) Bupivacaine (Bupivacaine) SS Duration 900 MG (1 D) INTRATHECAL Dysstasia 9 MG (1 D), Feeling Hot INTRATHECAL Granuloma Heart Rate Increased Hot Flush Hyperhidrosis Insomnia Loss Of Consciousness Medical Device Complication Mental Disorder SS C Manufacturer Route Nerve Injury Oedema Pain Speech Disorder Unevaluable Event Weight Increased Date:02/17/05ISR Number: 4590494-3Report Type:Expedited (15-DaCompany Report #20052173 Age: Gender:Male I/FU:F Outcome PT Dose Duration Hospitalization Condition Aggravated Initial or Prolonged Drug Withdrawal Syndrome Required Muscle Spasticity INTRATHECAL 180 MCG, Intervention to Pruritus DAILY, Prevent Permanent Pyrexia INTRATHECAL Impairment/Damage 22-Aug-2005 Page: 271 12:15 PM Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) 720 Mcg/Ml PS Morphine Sulphate C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:02/18/05ISR Number: 4587005-5Report Type:Expedited (15-DaCompany Report #PHBS2005US02266 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Drug Withdrawal Syndrome Initial or Prolonged Muscle Spasticity INTRATHECAL 180 ug/day Other Pruritus Pyrexia Report Source Product Role Manufacturer Baclofen Intrathecal PS Novartis Sector: Pharma Morphine Sulfate C Route Date:02/18/05ISR Number: 4587088-2Report Type:Expedited (15-DaCompany Report #PHNU2005DE00987 Age: Gender:Male I/FU:I Outcome Dose Duration Life-Threatening INTRATHECAL PT Report Source Cardiovascular Disorder Coma 50000 ug, Medication Error Product Role Manufacturer Lioresal Intratecal PS Novartis Sector: Pharma Timonil Sirdalud C C Route ONCE/SINGLE Respiratory Failure Date:02/22/05ISR Number: 4588705-3Report Type:Expedited (15-DaCompany Report #PHFR2005GB00884 Age:67 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Confusional State Initial or Prolonged Medication Error 10mg/day 8640 MIN 10 mg, QD 124 Report Source Product Role Manufacturer Route Baclofen PS Novartis Sector: Pharma ORAL Amitriptyline C ORAL Lansoprazole C ORAL Alfacalcidol C ORAL DAY 30 mg, QD 2 ug, QW2 Date:02/22/05ISR Number: 4591070-9Report Type:Direct Age:45 YR Gender:Female I/FU:I Company Report #CTU 240960 Outcome Dose Duration Hospitalization 20 MG PO TID Initial or Prolonged PT Report Source Depressed Level Of Product Role Baclofe PS Manufacturer Route ORAL Consciousness Myoclonus Date:02/25/05ISR Number: 4596237-1Report Type:Expedited (15-DaCompany Report #20052206 Age:53 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL DAILY, Required INTRATHECAL Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Device Failure Pruritus Health Professional Lioresal Intrathecal (Baclofen Injection) PS Pyrexia Respiratory Depression Date:02/25/05ISR Number: 4596238-3Report Type:Expedited (15-DaCompany Report #20052207 Age: Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 272 12:15 PM PT Catheter Related Infection Csf Bacteria Identified Incision Site Complication Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Meningitis Staphylococcal Infection Dose INTRATHECAL Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route Duration DAILY, INTRATHECAL Date:03/02/05ISR Number: 4598828-0Report Type:Expedited (15-DaCompany Report #230610K05USA Age:32 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 44 MCG, 3 IN PT Report Source Product Role Convulsion Meningitis Chemical Consumer Rebif (Interferon Beta) PS Lioresal (Baclofen) SS Muscle Spasms 1 WEEKS Thrombosis Urinary Tract Infection Date:03/02/05ISR Number: 4598968-6Report Type:Expedited (15-DaCompany Report #PHNU2004DE02948 Age:60 YR Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL PT Apnoea Coma Device Failure UNKNOWN; Hypotension Report Source Product Role Health Professional Other Baclofen Intrathecal (Baclofen) Solution For Infusion PS INTRATHECAL (SEE IMAGE) Date:03/03/05ISR Number: 4597250-0Report Type:Expedited (15-DaCompany Report #US-KINGPHARMUSA00001-K200500263 Age:42 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Blood Lactate Septra Tablets/Septra Ds Tablets PS King Pharmaceuticals, Inc. Combivir SS Dehydrogenase Increased Coversyl SS Bone Marrow Depression Prothrombin Level Decreased Viracept "Agouron" Depakine Chrono Lioresal "Ciba-Geigy" SS SS Route ORAL UNK, UNK 4 mg, qd SS Date:03/03/05ISR Number: 4598974-1Report Type:Expedited (15-DaCompany Report #PHFR2004GB04658 Age:56 YR Gender:Male I/FU:F Outcome PT Dose Duration Life-Threatening Coma Hospitalization Escherichia Infection Initial or Prolonged Incoherent INTRATHECAL UNKNOWN ; Meningitis Bacterial INTRATHECAL 22-Aug-2005 Page: 273 12:15 PM Report Source Product Role Health Professional Other Lioresal Intrathecal (Baclofen) Solution For Injection PS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/03/05ISR Number: 4599601-XReport Type:Expedited (15-DaCompany Report #20052215 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATRACHEAL DAILY, Required INTRATHECAL Intervention to Prevent Permanent Impairment/Damage PT Report Source Product Role Catheter Related Infection Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Manufacturer Route Meningitis Muscle Spasticity Staphylococcal Infection Date:03/03/05ISR Number: 4600073-7Report Type:Expedited (15-DaCompany Report #PHNU2005DE00987 Age: Gender:Male I/FU:I Outcome Dose Duration Life-Threatening PT Report Source Product Role Cardiovascular Disorder Coma Health Professional Lioresal Intratecal (Baclofen) Ampoule PS Medication Error Other 50000 UG, ONCE/SINGLE Respiratory Failure Timonil (Carbamazepine) Sirdalud (Tizanidine Hydrochloride) C C Date:03/04/05ISR Number: 4600418-8Report Type:Expedited (15-DaCompany Report #K200500263 Age:42 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged ORAL PT Report Source Product Alanine Aminotransferase Increased Aspartate Aminotransferase Increased Blood Lactate Dehydrogenase Increased Bone Marrow Depression Health Professional Other Septra Tablets/Septra Ds Tablets(Trimethoprim , Sulfamethoxazole) Tablet 80/400 Mg Combivir (Lamivudine, Zidovudine) Tablet Role PS SS ORAL Prothrombin Level Decreased Coversyl (Perindopril Erbumine) 4 Mg SS 4 MG, QD Viracept "Agouron" (Nelfinavir Mesilate) Depakine Chrono (Valproate Sodium, Valproic Acid) Lioresal "Ciba-Geigy" (Baclofen) Date:03/07/05ISR Number: 4602460-XReport Type:Expedited (15-DaCompany Report #20052192 Age: Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 274 12:15 PM PT Blister Blood Creatine Phosphokinase Increased Drug Withdrawal Syndrome Enzyme Abnormality Hepatic Enzyme Increased Hyperhidrosis SS Agouron SS SS Ciba-Geigy FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose INTRATHECAL Medical Device Complication Muscle Rigidity Report Source Product Role Pyrexia Tachypnoea Health Professional Lioresal Intrathecal(Baclofen Injection) 2000 Mcg/Ml PS Manufacturer Route Manufacturer Route Duration 300 MCG DAILY, INTRATHECAL Date:03/08/05ISR Number: 4603736-2Report Type:Direct Age:76 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 20 MG PO QID Initial or Prolonged 1 MG Q AM 2 PT Company Report #CTU 242303 Report Source Product Role Lethargy Baclofen 20 Mg PS Mental Status Changes Lorazepam 1 Mg SS ORAL Treatment Noncompliance MG Q HS Date:03/08/05ISR Number: 4604280-9Report Type:Direct Age:54 YR Gender:Male I/FU:I Outcome Dose Duration Life-Threatening 25 MG PO QHS PT Company Report #CTU 242244 Report Source Product Role Loss Of Consciousness Amitriptyline 25 Mg PS Suicide Attempt Baclofen SS Manufacturer Route ORAL Date:03/09/05ISR Number: 4606114-5Report Type:Expedited (15-DaCompany Report #US014707 Age:39 YR Gender:Female I/FU:F Outcome Dose PT Duration Report Source Product Role Manufacturer Route Hospitalization Drug Interaction 100 MG ORAL Initial or Prolonged Grand Mal Convulsion SUBCUTANEOUS 8 MIU QOD Study Provigil PS Consumer Betaseron SS Prednisone SS Baclofen SS Synthroid C ORAL SUBCUTANEOUS 15 MG 10 MG Date:03/10/05ISR Number: 4606722-1Report Type:Expedited (15-DaCompany Report #2005022019 Age:29 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged UNKNOWN 600 MG Other MG, 3 IN 1 PT Report Source Product Role Cystitis Depression (200 Diarrhoea Consumer Health Neurontin (Gabapentin) PS Baclofen (Baclofen) SS Professional Disturbance In Attention D), UNKNOWN Hallucination UNKNOWN 130 MG Hypotension (UNKNOWN) Insomnia Social Avoidant Behaviour 22-Aug-2005 Page: 275 12:15 PM Paracetamol (Paracetamol) Ibuprofen (Ibuprofen) Vicodin (Hydrocodone Bitartrate, Paracetamol) Ciprofloxacin (Ciprofloxacin) C C C C Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/10/05ISR Number: 4608969-7Report Type:Expedited (15-DaCompany Report #2004-BP-11398YA Age:41 YR Gender:Male I/FU:F Outcome Dose Duration Hospitalization 0.2 MG (NR) Initial or Prolonged PO Other PT Report Source Product Role Manufacturer Route Alanine Aminotransferase Foreign Harnal (Tamsulosin) PS ORAL Increased Health Aspartate Aminotransferase Professional Dantrium (Dantrolene Sodium) (Nr) SS ORAL Increased Blood Bilirubin Increased Lioresal (Dantrolene Sodium) (Nr) SS ORAL Blood Lactate Dehydrogenase Increased Ternelin (Tizanidine Hydrochloride) (Nr) SS ORAL 25 MG (NR) PO 6 DF (NR) PO 1 MG TID (NR, Gamma-Glutamyltransferase TID) PO Increased Liver Disorder Lymphocyte Stimulation Test Positive Malaise Date:03/14/05ISR Number: 4609508-7Report Type:Direct Age:73 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 10 MG TID Initial or Prolonged PT Mental Status Changes Vitamedin (Benfotiamine/B6/B12 ) (Nr) Diazepam (Diazepam) (Nr) C C Company Report #CTU 243164 Report Source Product Role Baclofen PS Dexamethasone Tramadol SS SS Oscal Asa Clonidine Docusate Guaifenesin Isosorbide Lisinopril Zocor Vitamin E C C C C C C C C C 1-2 TID Manufacturer Route Metoprolol C Date:03/15/05ISR Number: 4608733-9Report Type:Expedited (15-DaCompany Report #PHNU2005DE00955 Age:80 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Coma Depressed Level Of Lioresal PS Novartis Sector: Pharma ORAL Consciousness Risperdal SS ORAL Risperdal Durogesic SS C ORAL Zolpidem Ramipril C C ORAL ORAL Duration 10 mg, BID 1 mg, QD SUBCUTANEOUS 5760 MIN UNK, UNK Date:03/16/05ISR Number: 4612639-9Report Type:Expedited (15-DaCompany Report #20052232 Age: Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage 22-Aug-2005 Page: 276 12:15 PM PT Abasia Catheter Related Complication Drug Withdrawal Syndrome Granuloma Hypertonia FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Hypotonia Spinal Column Stenosis Dose INTRATHECAL Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Duration MCG, DAILY, INTRATHECAL Date:03/17/05ISR Number: 4615398-9Report Type:Expedited (15-DaCompany Report #2004070485 Age:19 YR Gender: I/FU:F Outcome Dose Death PT Report Source Product Role Completed Suicide Intentional Misuse Literature Health Gabapentin (Gabapentin) PS ORAL Professional Baclofen (Baclofen) (Baclofen) SS ORAL Oxybutynin (Oxybutynin) (Oxybutynin) SS ORAL Duration ORAL ORAL ORAL Date:03/22/05ISR Number: 4614907-3Report Type:Expedited (15-DaCompany Report #PHBS2005TW03936 Age:70 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Confusional State Initial or Prolonged Disorientation 5 mg, TID 4320 MIN Drug Toxicity Haemoglobin Decreased Leukoaraiosis Somnolence Report Source Product Role Manufacturer Route Baclofen PS Novartis Sector: Pharma ORAL Date:03/22/05ISR Number: 4614909-7Report Type:Expedited (15-DaCompany Report #PHBS2005US03938 Age:38 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Cerebral Artery Embolism Headache Hyperacusis Photophobia Date:03/23/05ISR Number: 4622248-3Report Type:Direct Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Medication Error INTRATHECAL 1250 MCG/DAY Initial or Prolonged IT 22-Aug-2005 Page: 277 12:15 PM Report Source Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Product Role Manufacturer Baclofen PS Elavil Levoxyl Cozaar Lipitor Protonix C C C C C Route Company Report #CTU 244040 Report Source Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:03/24/05ISR Number: 4617756-5Report Type:Expedited (15-DaCompany Report #PHBS2005US03938 Age:38 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL PT Report Source Cerebral Artery Embolism Headache Product Role Manufacturer Route Baclofen Intrathecal PS Novartis Sector: Pharma Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Hyperacusis Photophobia Date:03/24/05ISR Number: 4617784-XReport Type:Expedited (15-DaCompany Report #PHBS2005CA01725 Age:55 YR Gender:Female I/FU:F Outcome Dose Disability 20 mg/day UNKNOWN PT Report Source Duration Hypersensitivity Muscular Weakness 63360MIN Hydrochlorothiazide C Diazepam C Didrocal C Calcium C 25 mg, QD ORAL 5 mg, TID 20160MIN Date:03/24/05ISR Number: 4617871-6Report Type:Expedited (15-DaCompany Report #PHBS2005CA01725 Age:55 YR Gender:Female I/FU:F Outcome Dose Disability 20 mg/day UNKNOWN PT Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Duration Hypersensitivity Muscular Weakness 63360MIN Hydrochlorothiazide C Diazepam C Didrocal C Calcium C 25 mg, QD 5 mg, TID 20160MIN ORAL Date:03/28/05ISR Number: 4620061-4Report Type:Expedited (15-DaCompany Report #PHRM2005FR01124 Age:23 YR Gender:Male I/FU:I Outcome Dose Death PT Report Source Product Role Manufacturer Route Cardiac Failure Chromaturia Lioresal PS Novartis Sector: Pharma ORAL Dyspnoea Exertional Nervous System Disorder Overdose Amfetamine Morphine Duration 100 mg/day C C Date:03/29/05ISR Number: 4621748-XReport Type:Expedited (15-DaCompany Report #PHRM2005FR01112 Age:52 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 15 mg, TID 500 mg, 6QD SUBCUTANEOUS PT Product Role Manufacturer Route Blood Alkaline Phosphatase Increased Lioresal PS Novartis Sector: Pharma ORAL Blood Lactate Dafalgan SS Fraxiparine C Duphalac C ORAL 2880 MIN Dehydrogenase Increased 0.4 ml, QD Gamma-Glutamyltransferase 10 g, 6QD Increased Hepatitis Transaminases Increased 22-Aug-2005 Page: 278 Report Source 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/01/05ISR Number: 4628396-6Report Type:Expedited (15-DaCompany Report #20052246 Age: Gender:Male I/FU:F Outcome PT Dose Duration Hospitalization Cystitis Initial or Prolonged Drug Withdrawal Syndrome INTRATRACHEAL MCG, DAILY, Required Failure Of Implant INTRATHECAL Intervention to Heart Rate Increased Prevent Permanent Hypertonia Impairment/Damage Muscle Spasms Muscle Spasticity Pelvic Abscess Sepsis Report Source Product Role Health Professional Lioresal Intrathecan (Baclofen Injection) PS Manufacturer Route Date:04/04/05ISR Number: 4626071-5Report Type:Expedited (15-DaCompany Report #PHNU2005DE01513 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Novartis Sector: Pharma ORAL Manufacturer Route Duration Hypothyroidism Unknown Lioresal SS 100 mg/day Date:04/04/05ISR Number: 4628449-2Report Type:Expedited (15-DaCompany Report #20052265 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL DAILY, INTRATHECAL PT Muscle Spasticity Pyrexia Underdose 198 MCG, Report Source Product Role Health Professional Lioresal Intrathecal(Baclofen Injection)500mcg/Ml PS Date:04/06/05ISR Number: 4628674-0Report Type:Expedited (15-DaCompany Report #20052265 Age: Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged INTRATHECAL PT Muscle Spasticity Pyrexia Underdose 198 MCG, Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) 500 Mcg/Ml PS Manufacturer Route Manufacturer Route DAILY, INTRATHECAL Date:04/08/05ISR Number: 4633308-5Report Type:Expedited (15-DaCompany Report #20052290 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Drug Withdrawal Syndrome Initial or Prolonged Erythema INTRATHECAL MCG, DAILY, Implant Site Infection INTRATHECAL Muscle Spasticity Post Procedural Complication Pyrexia Staphylococcal Infection Swelling 22-Aug-2005 Page: 279 12:15 PM Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:04/11/05ISR Number: 4632024-3Report Type:Expedited (15-DaCompany Report #PHBS2005JP04814 Age:63 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Depressed Level Of Initial or Prolonged Consciousness 15 mg/day 2880 MIN Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Lasix C ORAL Zantac C ORAL Amlodin C ORAL Anplag C ORAL Calcium Carbonate C ORAL Neurovitan C ORAL Renagel C ORAL Cilostate C ORAL Diovan C ORAL Alfarol C ORAL Tryptanol C ORAL Tegretol C ORAL 80 mg/day 150 mg/day 10 mg/day 200 mg/day 3 g/day 3 df/day 750 mg/day 50 mg/day 80 mg/day 0.5 ug/day 40 mg/day 400 mg/day Date:04/11/05ISR Number: 4633096-2Report Type:Direct Age:46 YR Gender:Female I/FU:I Outcome Dose PT Company Report #CTU 245806 Report Source Product Role Manufacturer Route Baclofen PS ORAL Wellbutrin 300 Mg SS ORAL Duration Chest Pain 20 MG 3 TIMES Pain In Extremity A DAY ORAL 300 MG 1 TIME A DAY ORAL Vioxx Celebrex Bextra C C C Date:04/11/05ISR Number: 4635229-0Report Type:Expedited (15-DaCompany Report #20052246 Age: Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged Required INTRATHECAL DAILY, Intervention to INTRATHECAL Prevent Permanent Impairment/Damage PT Report Source Product Role Cystitis Drug Withdrawal Syndrome Heart Rate Increased Health Professional Lioresal Intrathecal(Baclofen Injection) PS Hypertonia Medical Device Complication Medication Error Muscle Spasticity Pelvic Abscess Pyrexia Urosepsis Date:04/13/05ISR Number: 4635614-7Report Type:Expedited (15-DaCompany Report #KII-2005-0015781 Age:36 YR Gender:Male I/FU:I Outcome Life-Threatening Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 280 12:15 PM PT Acidosis Agitation Bowel Sounds Abnormal Bradycardia Cardiac Arrest Coma Disorientation Electrocardiogram Qt Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Prolonged Hypertension Intentional Misuse Mydriasis Dose Report Source Product Role Manufacturer Route Study Health Professional Other Morphine Sulfate (Similar To Nd 19-516) (Morphine Sulfate) Unknown PS ORAL Clonazepam(Clonazepa m) SS ORAL Baclofen(Baclofen) SS ORAL Methocarbamol(Methoc arbamol) SS ORAL Gabapentin(Gabapenti n) SS Duration Pupillary Reflex Impaired Somnolence ORAL ORAL ORAL ORAL Date:04/18/05ISR Number: 4638119-2Report Type:Expedited (15-DaCompany Report #PHRM2005FR01234 Age:70 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Abasia Initial or Prolonged Alanine Aminotransferase 10 mg, TID 15840MIN Increased 2 DF, TID Aspartate 0.25 mg, TID Aminotransferase 25 mg, BID Increased Cerebral Atrophy Confusional State Escherichia Urinary Tract Infection Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Zaldiar SS ORAL Xanax C ORAL Anafranil C ORAL Dafalgan C ORAL Date:04/21/05ISR Number: 4641288-1Report Type:Expedited (15-DaCompany Report #PHFR2005GB01495 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Hallucination Muscle Spasms Baclofen PS Novartis Sector: Pharma Paranoia Dantrolene C Route Duration UNKNOWN UNKNOWN Date:04/22/05ISR Number: 4642762-4Report Type:Expedited (15-DaCompany Report #PHEH2005US04344 Age:17 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Zelnorm PS Novartis Sector: Pharma Klonopin Keppra Baclofen Ativan I I I I Depakote Prevacid I I Route Duration Mental Status Changes UNK, PRN Date:04/25/05ISR Number: 4643634-1Report Type:Expedited (15-DaCompany Report #PHBS2005JP04814 Age:63 YR Gender:Male I/FU:F Outcome PT Dose Duration Hospitalization Depressed Level Of Initial or Prolonged Consciousness 15 mg/day 2880 MIN 22-Aug-2005 Page: 281 12:15 PM Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Lasix C ORAL Zantac C ORAL Amlodin C ORAL Anplag C ORAL Calcium Carbonate C ORAL Neurovitan C ORAL Renagel C ORAL Cilostate C ORAL Diovan C ORAL Alfarol C ORAL Tryptanol C ORAL Tegretol C ORAL 80 mg/day 150 mg/day 10 mg/day 200 mg/day 3 g/day 3 df/day 750 mg/day 50 mg/day 80 mg/day 0.5 ug/day 40 mg/day 400 mg/day Date:04/27/05ISR Number: 4648618-5Report Type:Expedited (15-DaCompany Report #2005022833 Age:42 YR Gender:Male I/FU:F Outcome Dose Duration Life-Threatening PT Report Source Product Role Manufacturer Route Alanine Aminotransferase Increased Aplastic Anaemia Foreign Health Professional Viracept (Tablet) (Nelfinavir Mesilate) PS ORAL Aspartate Aminotransferase Increased Bactrim (Sulfamethoxazole, Trimethoprim) SS ORAL Blood Creatinine Abnormal Blood Lactate Dehydrogenase Increased Blood Urea Decreased Zidovudine W/Lamivudine (Lamivudine, Zidovudine) SS ORAL ORAL ORAL (2 IN 1 D), Bone Marrow Depression ORAL Epilepsy Prothrombin Level Decreased Ergenyl Chrono (Valproate Sodium, Valproic Acid) SS ORAL Perindopril (Perindopril) SS ORAL Baclofen (Baclofen) SS (2 IN 1 D), Prothrombin Time ORAL Shortened Treatment Noncompliance 4 MG (4 MG, 1 IN 1 D), ORAL Date:04/28/05ISR Number: 4647182-4Report Type:Expedited (15-DaCompany Report #PHBS2005US05720 Age:39 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 30 mg, QID PT Report Source Product Role Manufacturer Route Delirium Drug Withdrawal Syndrome Baclofen PS Novartis Sector: Pharma ORAL Heart Rate Increased Gabapentin C ORAL Overdose Oxycodone C ORAL Pyrexia Celecoxib C ORAL Self-Injurious Ideation Nifedipine C ORAL Suicide Attempt Omeprazole C ORAL Tizanidine C ORAL 400 mg, TID 60 mg, TID 100 mg, BID 60 mg/day 20 mg/day 12 mg, TID Date:04/28/05ISR Number: 4647183-6Report Type:Expedited (15-DaCompany Report #PHBS2002CL09569 Age:41 YR Gender:Male I/FU:F Outcome Other 22-Aug-2005 Page: 282 PT Abdominal Distension Abdominal Pain Upper Chest Wall Pain Choking Sensation 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Fatigue Flatulence Haematochezia Dose Report Source Product Role Manufacturer Route Pigmentation Disorder Somnolence Lioresal PS Novartis Sector: Pharma ORAL Urinary Incontinence Lioresal Novartis Sector: Pharma ORAL Novartis Sector: Pharma ORAL Novartis Sector: Pharma ORAL Manufacturer Route Manufacturer Route Duration 1 tablet/day SS 2 tablets/day Lioresal SS 4 tablets/day Lioresal SS 20 mg/day Diazepam C Losec C UNKNOWN UNKNOWN PRN Date:05/02/05ISR Number: 4651510-3Report Type:Expedited (15-DaCompany Report #20052273 Age: Gender:Male I/FU:F Outcome PT Dose Duration Hospitalization Catheter Related Initial or Prolonged Complication INTRATHECAL MCG, DAILY, Required Device Failure INTRATHECAL Intervention to Dizziness Prevent Permanent Migration Of Implant Impairment/Damage Vision Blurred Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Date:05/02/05ISR Number: 4652397-5Report Type:Expedited (15-DaCompany Report #20052321 Age: Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Device Malfunction Initial or Prolonged Respiratory Failure INTRATHECAL UNK MCG, Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Required DAILY, Intervention to INTRATHECAL Prevent Permanent Impairment/Damage Date:05/02/05ISR Number: 4652462-2Report Type:Expedited (15-DaCompany Report #20052219 Age: Gender: I/FU:F Outcome PT Dose Duration Life-Threatening Amnesia Hospitalization Coma INTRATHECAL MCG, DAILY, Initial or Prolonged Confusional State INTRATHECAL Required Convulsion Intervention to Hypertonia Prevent Permanent Hypotension Impairment/Damage Respiratory Disorder Shock Report Source Product Role Foreign Health Lioresal Intrathecal (Baclofen Injection) PS Manufacturer Route Manufacturer Route Professional Date:05/02/05ISR Number: 4652855-3Report Type:Expedited (15-DaCompany Report #PHFR2005GB01495 Age: Gender:Female I/FU:I Outcome Dose 22-Aug-2005 Page: 283 PT Report Source Product Role Hallucination Muscle Spasms Paranoia Health Professional Other Baclofen (Baclofen) Dantrolene (Dantrolene) PS Duration 12:15 PM C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/02/05ISR Number: 4652864-4Report Type:Expedited (15-DaCompany Report #PHNU2005DE00987 Age:37 YR Gender:Male I/FU:F Outcome PT Dose Duration Life-Threatening Cardiovascular Disorder Hospitalization Coma INTRATHECAL 50000 UG, Initial or Prolonged Convulsion ONCE/SINGLE Depressed Level Of INTRATHECAL Consciousness Disorientation Hypotension Incorrect Dose Administered Memory Impairment Muscle Spasticity Respiratory Failure Report Source Product Role Foreign Health Lioresal Intratecal (Baclofen) Ampoule PS Manufacturer Route Manufacturer Route Manufacturer Route Professional Other Timonil (Carbamazepine) Sirdalud (Tizanidine Hydrochloride) C C Date:05/02/05ISR Number: 4653037-1Report Type:Expedited (15-DaCompany Report #20052279 Age: Gender:Male I/FU:F Outcome PT Dose Duration Hospitalization Catheter Related Initial or Prolonged Complication INTRATHECAL MCG, DAILY, Device Failure INTRATHECAL Drug Withdrawal Syndrome Haematemesis Lethargy Melaena Overdose Pyrexia Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Miralax Mobic C C Date:05/12/05ISR Number: 4660527-4Report Type:Expedited (15-DaCompany Report #PHBS2002CL09569 Age:41 YR Gender:Male I/FU:F Outcome Dose PT Duration Report Source Product Role Other Abdominal Distension Abdominal Pain Upper Lioresal PS Chest Wall Pain Choking Sensation Lioresal Fatigue Flatulence Lioresal Haematochezia Pigmentation Disorder Lioresal Somnolence Diazepam C Urinary Incontinence Losec C Novartis Sector: Pharma ORAL Novartis Sector: Pharma ORAL Novartis Sector: Pharma ORAL Novartis Sector: Pharma ORAL 1 tablet/day SS 2 tablets/day SS 4 tablets/day SS 20 mg/day UNKNOWN UNKNOWN PRN Date:05/12/05ISR Number: 4660535-3Report Type:Expedited (15-DaCompany Report #PHNU2005DE01924 Age:48 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Blood Chloride Decreased Blood Sodium Decreased Lioresal PS Novartis Sector: Pharma ORAL Delusional Disorder, Persecutory Type Detrusitol Spasmex Duration 7200 MIN 22-Aug-2005 Page: 284 12:15 PM C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:05/12/05ISR Number: 4661366-0Report Type:Expedited (15-DaCompany Report #05-05-0802 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Hallucination Muscle Spasms Paranoia Foreign Other Baclofen Baclofen Dantrolene PS SS C Manufacturer Route Manufacturer Route Duration Date:05/20/05ISR Number: 4669855-XReport Type:Expedited (15-DaCompany Report #20052351 Age: Gender:Female I/FU:I Outcome PT Dose Duration Required Implant Site Reaction Intervention to Inflammation INTRATHECAL MCG, DAILY, Prevent Permanent Mass INTRATHECAL Impairment/Damage Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Date:05/23/05ISR Number: 4669589-1Report Type:Expedited (15-DaCompany Report #PHNU2005DE01956 Age: Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Manufacturer Route Duration Hypothermia 5 mg, TID Date:05/23/05ISR Number: 4672802-8Report Type:Expedited (15-DaCompany Report #PHBS2005BE06441 Age: Gender:Male I/FU:I Outcome Dose INTRATHECAL PT Report Source Product Role Cholestasis Foreign Health Professional Lioresal (Baclofen) Ampoule PS Duration 1 MG/KG/DAY, Other INTRATHECAL Date:05/24/05ISR Number: 4672877-6Report Type:Expedited (15-DaCompany Report #05-05-0914 Age:4 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization 2.5 MG MANE Initial or Prolonged ORAL Disability PT Report Source Product Role Colitis Foreign Baclofen PS Manufacturer Route ORAL Other Date:05/24/05ISR Number: 4674153-4Report Type:Expedited (15-DaCompany Report #KII-2005-0016647 Age:30 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Manufacturer Route Agitation Bowel Sounds Abnormal Coma Disorientation Hypotension Study Health Professional Other Hydromorphone Hcl (Similar To Nda 21-044) (Hydromorphone Hydrochloride) PS ORAL Methadone (Methadone) SS ORAL Gabapentin (Gabapentin) SS ORAL Amitriptyline (Amitriptyline) SS ORAL Baclofen (Baclofen) SS ORAL ORAL Mydriasis Tachycardia ORAL ORAL ORAL ORAL 22-Aug-2005 Page: 285 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Benzodiazepine Derivatives () SS ORAL Antiepileptics() SS ORAL Warfarin (Warfarin) SS ORAL ORAL ORAL ORAL Date:05/26/05ISR Number: 4674599-4Report Type:Expedited (15-DaCompany Report #PHFR2005GB01910 Age:4 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 2.5mg Mane; Disability 5mg Nocte PT Report Source Colitis Product Role Manufacturer Route Baclofen PS Novartis Sector: Pharma ORAL Date:05/26/05ISR Number: 4674600-8Report Type:Expedited (15-DaCompany Report #PHBS2005JP04814 Age:63 YR Gender:Male I/FU:F Outcome PT Dose Duration Hospitalization Depressed Level Of Initial or Prolonged Consciousness 5 mg, TID 2880 MIN Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Lasix C ORAL Zantac C ORAL Amlodin C ORAL Anplag C ORAL Calcium Carbonate C ORAL Neurovitan C ORAL Renagel C ORAL Cilostate C ORAL 80 mg/day 150 mg/day 10 mg/day UNK, UNK UNK, UNK 3 df/day UNK, UNK UNK, UNK Diovan C ORAL Alfarol C ORAL Tryptanol C ORAL Tegretol C ORAL UNK, UNK UNK, UNK UNK, UNK UNK, UNK Date:05/26/05ISR Number: 4674603-3Report Type:Expedited (15-DaCompany Report #PHFR2005GB01495 Age:15 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Hallucination Muscle Spasms Baclofen PS Novartis Sector: Pharma ORAL Paranoia Senna C Dantrolene C Valproate Sodium C Duration 40 mg/day 2 tabs nocte UNKNOWN 400 mg/day Date:05/27/05ISR Number: 4678272-8Report Type:Expedited (15-DaCompany Report #KII-2005-0016712 Age:54 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 286 12:15 PM PT Atrioventricular Block First Degree Blood Pressure Systolic Increased Convulsion Depressed Level Of Consciousness Drug Ineffective Hypokalaemia Hypotension Intentional Misuse ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Multiple Drug Overdose Simple Partial Seizures Sinus Bradycardia Dose Report Source Product Role Manufacturer Route Study Health Professional Other Morphine Sulfate (Similar To Nda 19-516) (Moprhine Sulfate) Other PS ORAL Baclofen (Baclofen) SS ORAL Duration 60 MG, SEE TEXT, ORAL ORAL Date:06/02/05ISR Number: 4679421-8Report Type:Expedited (15-DaCompany Report #1996AS00236 Age:13 YR Gender:Male I/FU:F Outcome Dose Other EPIDURAL PT Report Source Product Role Naropin PS Baclofen Imipramine Hydrochloride Diazepam SS Manufacturer Route Duration Blood Pressure Decreased DOSE: 20 MG 1 DAY Bundle Branch Block Cardiac Septal Defect Convulsive Threshold Lowered Drug Level Increased Drug Toxicity Grand Mal Convulsion Incorrect Route Of Drug Administration Sinus Tachycardia Tachycardia SS C Date:06/02/05ISR Number: 4679967-2Report Type:Expedited (15-DaCompany Report #PHNU2005DE01956 Age:45 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Drug Toxicity Hypothermia Lioresal PS Novartis Sector: Pharma ORAL Leukopenia Zoloft Duration 5 mg, TID 50 mg/day SS ORAL Thrombocytopenia Acimethin C ORAL Pantozol C ORAL Torem C ORAL Acetylsalicylic Acid C ORAL 1500 mg/day 40 mg/day 5 mg, QD 100 mg, QD Date:06/02/05ISR Number: 4679968-4Report Type:Expedited (15-DaCompany Report #PHFR2005GB01965 Age: Gender:Female I/FU:I Outcome PT Dose Duration Life-Threatening Blood Creatinine Hospitalization Increased 40 mg, QD Initial or Prolonged Drug Level Increased 36mg/day Other Epilepsy UNKNOWN 400 mg, BID Glasgow Coma Scale 2.5mg/day Abnormal Hallucination Loss Of Consciousness Overdose Renal Failure Acute Urinary Tract Infection 22-Aug-2005 Page: 287 12:15 PM Report Source Product Role Manufacturer Route Baclofen PS Novartis Sector: Pharma ORAL Tizanidine SS Gabapentin SS Bendrofluazide C ORAL ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/03/05ISR Number: 4680697-1Report Type:Expedited (15-DaCompany Report #1999AU14180 Age:13 YR Gender:Male I/FU:F Outcome Dose Other EPIDURAL PT Report Source Product Role Ropivacaine PS Baclofen Imipramine SS SS Manufacturer Route Manufacturer Route Duration Bundle Branch Block DOSE: 20 mg Grand Mal Convulsion Tachycardia Date:06/03/05ISR Number: 4684546-7Report Type:Expedited (15-DaCompany Report #20052367 Age: Gender: I/FU:I Outcome PT Dose Duration Hospitalization Cardiac Enzymes Increased Initial or Prolonged Loss Of Consciousness INTRATHECAL MCG, DAILY, Required Urosepsis INTRATHECAL Intervention to Prevent Permanent Impairment/Damage Report Source Product Role Health Professional Lioresal Intrathecal (Baclofen Injection) PS Company Representative Date:06/06/05ISR Number: 4682607-XReport Type:Expedited (15-DaCompany Report #PHNU2004DE04093 Age: Gender:Male I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Condition Aggravated Confusional State Lioresal PS Novartis Sector: Pharma ORAL General Physical Health Deterioration Lioresal Novartis Sector: Pharma ORAL Nausea Trileptal "Novartis" Duration 5 mg, BID SS 2.5 mg, BID C 900mg/day Vomiting Date:06/07/05ISR Number: 4683825-7Report Type:Expedited (15-DaCompany Report #GB-JNJFOC-20050600391 Age:71 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged OROPHARINGEAL PT Report Source Dyskinesia Vomiting 6 Product Role Tramadol Hydrochloride PS Tramadol Hydrochloride SS Baclofen SS Asprin C Frusemide C Senna C Manufacturer Route Route DAY OROPHARINGEAL 6 DAY OROPHARINGEAL 6 DAY OROPHARINGEAL OROPHARINGEAL OROPHARINGEAL Date:06/07/05ISR Number: 4683919-6Report Type:Expedited (15-DaCompany Report #PHFR2005GB02015 Age: Gender:Male I/FU:I Outcome Dose Other UNKNOWN 22-Aug-2005 Page: 288 PT Report Source Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Duration Confusional State Creatinine Renal 10 mg, TID Clearance Decreased Renal Impairment Sedation 12:15 PM FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:06/07/05ISR Number: 4684072-5Report Type:Expedited (15-DaCompany Report #PHBS2005IE07820 Age:42 YR Gender:Female I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Asthenia Bradycardia Lioresal PS Novartis Sector: Pharma ORAL Syncope Lithium Manufacturer Route Manufacturer Route Duration 5 mg C Date:06/07/05ISR Number: 4685227-6Report Type:Expedited (15-DaCompany Report #05-06-0968 Age: Gender:Male I/FU:I Outcome Dose Other 10 MG TDS PT Report Source Product Role Confusional State Foreign Baclofen -Ipi PS Renal Impairment Sedation Other Duration Date:06/08/05ISR Number: 4687999-3Report Type:Expedited (15-DaCompany Report #20052372 Age:17 YR Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Blood Pressure Decreased Initial or Prolonged Blood Test Abnormal Required Catheter Related INTRATHECAL MCG, DAILY, Intervention to Complication INTRATHECAL Prevent Permanent Device Failure Impairment/Damage Drug Administration Error Drug Withdrawal Syndrome Heart Rate Increased Hyperhidrosis Infection Pain In Extremity Report Source Product Role Health Professional Lioresal Intrathecal(Baclofen Injection) PS Date:06/13/05ISR Number: 4688716-3Report Type:Expedited (15-DaCompany Report #PHRM2005FR01742 Age:23 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Manufacturer Route Alanine Aminotransferase Increased Aspartate Lioresal PS Novartis Sector: Pharma ORAL Iuvacor C Aminotransferase Increased Oxygen Seretide C C Asthenia Blood Alkaline Ventoline Meteospasmyl C C UNKNOWN UNK, UNK PRN Phosphatase Increased Blood Bilirubin Increased Chromaturia Chronic Hepatitis Cytolytic Hepatitis Faeces Discoloured Jaundice Pruritus Date:06/15/05ISR Number: 4691421-0Report Type:Expedited (15-DaCompany Report #KII-2005-0016870 Age:63 YR Gender:Female I/FU:I Outcome Other 22-Aug-2005 Page: 289 PT Abnormal Behaviour Anger 12:15 PM ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dose Cerebral Ischaemia Confusional State Drug Ineffective Report Source Product Role Hostility Hypertension Somnolence Thinking Abnormal Study Health Professional Other Oxycontin Tablet (Oxycodone Hydrochloride) Cr Tablet PS ORAL Flexeril (Cyclobenzaprine Hydrochloride) SS ORAL Amitriptyline (Amitriptyline) SS ORAL Baclofen (Baclofen) SS ORAL Manufacturer Route Duration HS, ORAL SEE TEXT, ORAL SEE TEXT, ORAL DAILY, ORAL Date:06/17/05ISR Number: 4695697-5Report Type:Direct Age: Gender: I/FU:I Outcome Dose Other PT Company Report #CTU 251410 Report Source Product Role Baclofen PS Manufacturer Route Manufacturer Route Duration Drug Dispensing Error Medication Error Date:06/20/05ISR Number: 4696318-8Report Type:Expedited (15-DaCompany Report #2005087341 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Blood Pressure Abnormal Chest Pain Drug Ineffective Heart Rate Irregular Hepatic Cyst Mobility Decreased Multiple Sclerosis Consumer Bextra (Valdecoxib) Celebrex (Celecoxib) Baclofen (Baclofen) Vioxx (Rofecoxib) Rebif (Interferon Beta) Biaxin PS SS SS SS SS Nausea Spinal Cord Injury (Clarithromycin) Skelaxin (Metaxalone) SS SS Date:06/21/05ISR Number: 4698265-4Report Type:Expedited (15-DaCompany Report #20052321 Age: Gender:Female I/FU:F Outcome PT Dose Duration Hospitalization Device Failure Initial or Prolonged Respiratory Failure Required INTRATHECAL MCG, DAILY, Intervention to INTRATHECAL Prevent Permanent Impairment/Damage Report Source Product Role Health Professional Lioresal Intrathecal(Baclofen Injection) PS Manufacturer Route Date:06/22/05ISR Number: 4697061-1Report Type:Expedited (15-DaCompany Report #PHRM2005FR01836 Age:42 YR Gender:Female I/FU:I Outcome Dose Other 150 mg PT Product Role Manufacturer Route Accidental Overdose Hypotonia Lioresal PS Novartis Sector: Pharma ORAL Salivary Hypersecretion Somnolence Lioresal Novartis Sector: Pharma ORAL 1440 MIN 30 mg/day 22-Aug-2005 Page: 290 Report Source Duration 12:15 PM SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Topalgic "Houde" Spasfon C C Microlax C ORAL UNKNOWN RECTAL Date:06/22/05ISR Number: 4698580-4Report Type:Expedited (15-DaCompany Report #20052367 Age: Gender:Unknown I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged Required INTRATHECAL DAILY, Intervention to INTRATHECAL Prevent Permanent Impairment/Damage PT Report Source Product Role Autonomic Nervous System Imbalance Disease Progression Health Professional Company Lioresal Intrathecal(Baclofen Injection) PS Loss Of Consciousness Representative Manufacturer Route Manufacturer Route Multiple Sclerosis Myocardial Infarction Orthostatic Hypotension Urosepsis Date:06/22/05ISR Number: 4699427-2Report Type:Expedited (15-DaCompany Report #ACO_0169_2005 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization 36 MG PO Initial or Prolonged 800 MG PO PT Report Source Product Role Epilepsy Foreign Zanaflex PS ORAL Glasgow Coma Scale Health Gabapentin SS ORAL Abnormal Professional Baclofen SS ORAL Hallucination Intentional Misuse Loss Of Consciousness Overdose Renal Failure Acute Urinary Tract Infection Other Ciprofloxacin Bendrofluazide C C 40 MG PO Date:06/27/05ISR Number: 4700189-0Report Type:Expedited (15-DaCompany Report #PHBS2005JP04814 Age:63 YR Gender:Male I/FU:F Outcome PT Dose Duration Hospitalization Depressed Level Of Initial or Prolonged Consciousness 5 mg, TID 2880 MIN Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Lasix C ORAL Zantac C ORAL Amlodin C ORAL Anplag C ORAL Calcium Carbonate C ORAL Neurovitan C ORAL Renagel C ORAL Cilostate C ORAL Diovan C ORAL Alfarol C ORAL Tryptanol C ORAL Tegretol C ORAL 80 mg/day 150 mg/day 10 mg/day 200 mg/day 3 g/day 3 df/day 750 mg/day 100 mg/day 80 mg/day 0.5 ug/day 40 mg/day 400 mg/day Date:06/29/05ISR Number: 4702446-0Report Type:Expedited (15-DaCompany Report #PHRM2005FR01836 Age:42 YR Gender:Male I/FU:F Outcome Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 291 12:15 PM PT Areflexia Drug Dispensing Error Dry Mouth FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Enuresis Medication Error Psychomotor Skills Dose Report Source Impaired Somnolence 150 mg Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Novartis Sector: Pharma ORAL Duration 1440 MIN Lioresal SS 10 mg, 6QD Topalgic "Houde" Spasfon Microlax C C C Lovenox C ORAL ORAL RECTAL Date:07/06/05ISR Number: 4707038-5Report Type:Expedited (15-DaCompany Report #PHBS2005CN09312 Age:64 YR Gender:Male I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Route Duration Glaucoma 120 to 160 mg/day Date:07/07/05ISR Number: 4708591-8Report Type:Expedited (15-DaCompany Report #PHFR2005GB02359 Age: Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 80-100mg 274 DAY Other PT Report Source Product Role Manufacturer Drug Withdrawal Syndrome Muscular Weakness Lioresal PS Novartis Sector: Pharma Myalgia Tachycardia Ginger SS Date:07/07/05ISR Number: 4708621-3Report Type:Expedited (15-DaCompany Report #200512160FR Age:14 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Convulsion Drug Effect Decreased Drug Level Below Therapeutic Drug Level Decreased Postictal State Product Role Manufacturer Rifadine PS Aventis Pharmaceuticals Inc. Artane Oflocet Depakine Lioresal SS SS SS SS Route ORAL ORAL ORAL ORAL INTRATHECAL Date:07/07/05ISR Number: 4708859-5Report Type:Expedited (15-DaCompany Report #2005087341 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 292 12:15 PM PT Report Source Product Role Blood Pressure Fluctuation Chest Pain Drug Ineffective Heart Rate Irregular Hepatic Cyst Multiple Sclerosis Nausea Consumer Health Professional Bextra (Valdecoxib) Celebrex PS (Celecoxib) Baclofen (Baclofen) Vioxx (Rofecoxib) Rebif (Interferon Beta) Biaxin (Clarithromycin) Skelaxin SS SS SS SS SS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report (Metaxalone) SS Date:07/07/05ISR Number: 4709519-7Report Type:Expedited (15-DaCompany Report #2005087341 Age: Gender:Female I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Blood Pressure Fluctuation Chest Pain Drug Ineffective Heart Rate Irregular Hepatic Cyst Multiple Sclerosis Nausea Consumer Health Professional Bextra (Valdecoxib) Celebrex (Celecoxib) Baclofen (Baclofen) Vioxx (Rofecoxib) Rebif (Interferon Beta) Biaxin (Clarithromycin) Skelaxin (Metaxolone) PS SS SS SS Manufacturer Route SS SS C Date:07/11/05ISR Number: 4710613-5Report Type:Expedited (15-DaCompany Report #PHBS2005IE07820 Age:42 YR Gender:Female I/FU:F Outcome Dose Other PT Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Lithium C Manufacturer Route Duration Asthenia Bradycardia Syncope Date:07/11/05ISR Number: 4711302-3Report Type:Expedited (15-DaCompany Report #05-07-1153 Age:49 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged 10MG TID ORAL PT Report Source Product Role Blood Creatine Phosphokinase Increased Consumer Baclofen - Ipi Tablets PS Chest Pain Hypoaesthesia Oral Mitral Valve Prolapse Palpitations Paraesthesia Oral ORAL Date:07/12/05ISR Number: 4711987-1Report Type:Expedited (15-DaCompany Report #PHBS2005AT09514 Age: Gender:Male I/FU:F Outcome Dose Duration Hospitalization Initial or Prolonged 25 mg, TID Disability INTRATHECAL PT Report Source Product Role Manufacturer Route Adhesion Asthenia Lioresal PS Novartis Sector: Pharma ORAL Motor Dysfunction Lioresal Intrathecal Oedema Date:07/13/05ISR Number: 4713077-0Report Type:Expedited (15-DaCompany Report #PHHO2005US10718 Age:81 YR Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 293 12:15 PM PT Adrenal Adenoma Bladder Mass Dehydration Haematuria Hypotension Mental Status Changes SS FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Sedation Syncope Urinary Tract Infection Dose INTRAVENOUS Report Source Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Zoledronic Acid Vs Placebo SS Ativan Pentoxifylline Lasix Calcium Carbonate Vitamin D SS SS SS C C Route Duration Double-blind Date:07/13/05ISR Number: 4714224-7Report Type:Direct Age:45 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Company Report #CTU 253147 Report Source Difficulty In Walking Post Procedural Complication Product Role Baclofen . Neurontin Tylenol PS C C C Manufacturer Route Date:07/15/05ISR Number: 4715316-9Report Type:Expedited (15-DaCompany Report #FR-ABBOTT-05P-056-0305095-00 Age:14 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Report Source Product Role Convulsion Drug Effect Decreased Drug Interaction Depakine Tablets Rifampicin Morphine PS SS C Drug Level Decreased Morphine C Morphine C Ofloxacin Baclofen I I Manufacturer Route ORAL ORAL UNKNOWN UNKNOWN UNKNOWN INTRATHECAL through 125 mg daily ORAL implantable intrathecal pump Trihexyphenidyl Hydrochloride Date:07/15/05ISR Number: 4715673-3Report Type:Direct Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Device Failure INTRATHECAL 1400 MG OVER Initial or Prolonged Hypotension 24 HOURS Required Lethargy INTRATHECA Intervention to Loss Of Consciousness Prevent Permanent Overdose Impairment/Damage Urinary Retention Company Report #CTU 253397 Report Source Product Role Lioresal PS Date:07/19/05ISR Number: 4719507-2Report Type:Expedited (15-DaCompany Report #20052426 Age: Gender:Male I/FU:I Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 294 12:15 PM I Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Required Intervention to Prevent Permanent Dose Duration Impairment/Damage INTRATHECAL PT Report Source Product Role Asthenia Diplegia Granuloma Health Professional Lioresal Intrathecal(Baclofen Injection) 2000 Mcg/Ml PS Manufacturer Route Manufacturer Route Manufacturer Route MCG, DAILY, INTRATHECAL Date:07/19/05ISR Number: 4720549-1Report Type:Expedited (15-DaCompany Report #20052419 Age: Gender:Male I/FU:I Outcome PT Dose Duration Hospitalization Atrial Fibrillation INTRATHECAL 700-1100 MCG, Initial or Prolonged Catheter Related DAILY, Required Complication INTRATHEC Intervention to Drug Withdrawal Syndrome Prevent Permanent Dysphonia Impairment/Damage Fluid Retention Hallucination Mental Status Changes Muscle Spasticity Post Procedural Complication Pruritus Pulmonary Embolism Screaming Report Source Product Role Health Lioresal PS Professional Date:07/22/05ISR Number: 4722538-XReport Type:Expedited (15-DaCompany Report #JP-JNJFOC-20050700852 Age:14 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged PT Convulsion Drug Interaction Drug Level Below Report Source Product Role Oflocet Artane Rifadine PS SS SS ORAL ORAL ORAL Therapeutic Lioresal SS Postictal State Depakine I INTRATRACHEAL ORAL Date:07/25/05ISR Number: 4726181-8Report Type:Expedited (15-DaCompany Report #20052437 Age: Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged DAILY, PT Report Source Product Role Gait Disturbance Generalised Oedema Foreign Health Lioresal Intrathecal (Baclofen Injection) PS Hypotonia Professional Manufacturer Route Manufacturer Route INTRATHECAL Laboratory Test Abnormal Date:07/25/05ISR Number: 4726243-5Report Type:Expedited (15-DaCompany Report #PHBS2005AT09514 Age: Gender:Male I/FU:F Outcome PT Dose Duration Hospitalization Adhesion Initial or Prolonged Asthenia INTRATHECAL INTRATHECAL Disability Brain Oedema Motor Dysfunction 25 MG, TID Muscular Weakness ORAL Oedema 22-Aug-2005 Page: 295 12:15 PM Report Source Product Role Foreign Health Lioresal Intrathecal (Baclofen) Ampoule PS Professional Other Lioresal (Baclofen) Tablet SS ORAL FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:07/27/05ISR Number: 4725756-XReport Type:Expedited (15-DaCompany Report #PHNR2005AU01158 Age: Gender: I/FU:I Outcome Dose Other PT Report Source Product Role Manufacturer Route Lioresal PS Novartis Sector: Pharma ORAL Manufacturer Route Manufacturer Route Duration Delusion Psychotic Disorder 100-150 mg, daily Date:07/27/05ISR Number: 4727384-9Report Type:Direct Age:66 YR Gender:Female I/FU:I Outcome Dose Duration Hospitalization [PAST WEEK] Initial or Prolonged PT Company Report #CTU 254537 Product Role Drug Toxicity Baclofen PS Mental Status Changes Lipitor Glipizide Zemplar Epogen Insulin Prevacid Vicodin Trazodone Plavix Pro-Med C C C C C C C C C C Date:07/27/05ISR Number: 4727426-0Report Type:Direct Age:67 YR Gender:Female I/FU:I Outcome PT Dose Duration Hospitalization Hypotension Initial or Prolonged Hypoventilation INTRATHECAL 20 MG/ML , 4 Hypoxia MG DAILY IT Lethargy [LONG TERM] Respiratory Depression INTRATHECAL 28 MCG DAILY Report Source Company Report #CTU 254510 Report Source Product Role Hydromorphone 20 Mg/Ml PS Baclofen 140 Mg /Ml SS Sedation IT [LONG Somnolence TERM] Ambien Propoxyphene Singulair Promethazine Lamictal Zanaflex Paxil Neurotin Zetia Nexium Maxide Dicyclomine Patanol Nasonex Diazepam Clarinex Coumadin Date:08/01/05ISR Number: 4730631-0Report Type:Expedited (15-DaCompany Report #PHHO2005US10718 Age:81 YR Gender:Male I/FU:F Outcome Hospitalization Initial or Prolonged 22-Aug-2005 Page: 296 12:15 PM PT Adrenal Adenoma Bladder Mass C C C C C C C C C C C C C C C C C FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Dehydration Haematuria Hypotension Dose INTRAVENOUS Report Source Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Zoledronic Acid Vs Placebo SS Ativan Pentoxifylline Lasix Calcium Carbonate Vitamin D SS SS SS C C Route Duration Mental Status Changes Sedation Syncope Urinary Tract Infection Double-blind Date:08/01/05ISR Number: 4732408-9Report Type:Expedited (15-DaCompany Report #KII-2005-0017700 Age:56 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Role Manufacturer Route Body Temperature Increased Confusional State Hypertension Lethargy Study Health Professional Other Oxycodone Hydrochloride (Similar To Nda 20-553) (Oxycodone Hydrochloride) PS ORAL Tramadol (Tramadol) SS ORAL Acetaminophen With Propoxyphene (Acetaminophen With Propoxyphene) SS ORAL Baclofen (Baclofen) SS ORAL ORAL Tremor ORAL ORAL ORAL Date:08/01/05ISR Number: 4733088-9Report Type:Direct Age:80 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization 5 MG PO TID PT Dyskinesia Company Report #CTU 254843 Report Source Product Role Baclofen PS Manufacturer Route ORAL Initial or Prolonged 60 MG PO Q 12 Required H Intervention to PRN Prevent Permanent Impairment/Damage Fall 22-Aug-2005 Page: 297 12:15 PM SS Diphenhydramine SS Morphine Hydrocodone/Apap SS C ORAL Mental Status Changes Pain Date:08/01/05ISR Number: 4733092-0Report Type:Direct Age:49 YR Gender:Male I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Required Intervention to Prevent Permanent Impairment/Damage Promethazine PT Agitation Headache Hyperhidrosis Hypotension Hypoxia Insomnia Pyrexia Sepsis Serotonin Syndrome Tremor Company Report #CTU 254840 Report Source Product Role Baclofen Buspirone Mirtazapine Quetiapine Sertraline Tramadol PS SS SS SS SS SS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Date:08/02/05ISR Number: 4735675-0Report Type:Expedited (15-DaCompany Report #2005-02654 Age:1 DY Gender: I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other PT Report Source Product Convulsion Neonatal Drug Exposure During Pregnancy General Physical Health Deterioration Neonatal Respiratory Distress Syndrome Premature Baby Health Professional Baclofen (Watson Laboratories) (Baclofen) Tablet Vicodin (Paracetamol) Enbrel (Etanercept) Role Manufacturer PS Watson Laboratories Route SS SS Date:08/10/05ISR Number: 4741421-7Report Type:Expedited (15-DaCompany Report #PHHO2005US10718 Age:81 YR Gender:Male I/FU:F Outcome Dose Duration Death Hospitalization Initial or Prolonged INTRAVENOUS PT Adrenal Adenoma Anaemia Bladder Cancer Bladder Mass Double-blind Confusional State Dehydration General Physical Health Deterioration Haematocrit Decreased Haematuria Haemoglobin Decreased Hypokalaemia Hyponatraemia Hypotension Mental Status Changes Sedation Syncope Urinary Tract Infection Report Source Product Role Manufacturer Baclofen PS Novartis Sector: Pharma Zoledronic Acid Vs Placebo SS Ativan Pentoxifylline Lasix Calcium Carbonate Vitamin D SS SS SS C C Date:08/11/05ISR Number: 4742577-2Report Type:Expedited (15-DaCompany Report #PHBS2005JP11296 Age: Gender: I/FU:I Route Outcome Dose Other PT Report Source Product Role Manufacturer Lioresal PS Novartis Sector: Pharma Lioresal SS Novartis Sector: Pharma Route Duration Abdominal Distension Gastrointestinal Disorder 5 mg 5 mg TID Date:08/18/05ISR Number: 4747946-2Report Type:Expedited (15-DaCompany Report #US-ABBOTT-05P-163-0307987-00 Age: Gender: I/FU:I Outcome Dose Duration Hospitalization Initial or Prolonged Other 22-Aug-2005 Page: 298 12:15 PM PT Convulsion Convulsion Neonatal Drug Exposure During Pregnancy Neonatal Respiratory Distress Syndrome Premature Baby Premature Labour Respiratory Distress Report Source Product Role Vicodin Baclofen Etanercept PS SS SS Manufacturer Route FDA - Adverse Event Reporting System (AERS) Freedom Of Information (FOI) Report Summary report for FOI selections: Selection by inexact search of active ingredient: BACLOFEN% Selection by inexact search of Tradename/Verbatim: LIORESAL% Total number of reports: From: 01-NOV-1997 To: 1,270 Present 22-Aug-2005 Page: 299 12:15 PM
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