Download Express Scripts Drug Information & Wellness Center Drug Information Updates

July 2011
Volume 3 Issue 5
Express Scripts Drug Information & Wellness Center
Drug Information Updates
In the News:
FDA warns healthcare providers not to use simvastatin 80 mg in new patients
Special points of interest:
 Intended to reduce risk of serious muscle injury
 In the News
 This recommendation was prompted due to a review of data from clinical trials & the FDA
Adverse Event Reporting System
 New Formulations and Indications
 Simvastatin 80 mg/day is only recommended in those that have taken this amount for at
least 12 months & have had no myopathy symptoms
 New Generic Approvals
 Approximately 2.1 million U.S. patients were prescribed a product containing simvastatin 80
mg during 2010
Chantix (varenicline) may increase risk of cardiovascular events
 A meta-analysis published in the Canadian Medical Association Journal examined more
than 8,000 patients who received either Chantix or placebo
 The authors concluded that smokers who took Chantix were associated with a 72%
increased risk of having a serious cardiovascular event

The FDA previously released a notice to public about a possible association of Chantix with
a small increase in certain cardiovascular adverse events in patients with heart disease
Boostrix Vaccine now approved for use in adults 65 years and older
New Formulations and Indications:
Lazanda (fentanyl nasal spray) by Archimedes Pharma Ltd.
Class: Opiate agonist
Indication: Breakthrough pain in cancer patients already receiving and tolerant to opioid therapy
MOA: Mu- and kappa-opiate receptor agonist that changes perception of pain to produce analgesia
New Formulation: Metered nasal spray, 100 or 400 mcg per spray; 5 ml bottle containing 8 sprays
Oxecta (oxycodone hcl) by Pfizer
Class: Opiate agonist
Indication: Management of acute and chronic moderate to severe pain
MOA: Mu-opiate receptor agonist that changes perception of pain to produce analgesia
New Formulation: 5 mg and 7.5 mg tablets; tamper-resistant formulation to discourage abuse
Codeine Sulfate oral solution by Roxane
Class: Opiate agonist
Indication: Mild to moderate pain
MOA: Converted to morphine in body and changes perception of pain to produce analgesia
New formulation: Oral solution 30 mg/5 ml
Rectiv (nitroglycerin) ointment by ProStrakan
Class: Nitrate
New Indication: Moderate to severe pain associated with chronic anal fissures
MOA: Donates nitric oxide and relaxes smooth muscle fibers in anal sphincter and arterial walls
New Dose Available: 0.4% ointment for intra-anal use
New Generic Approvals:
Levofloxacin
Flucytosine
Fondaparinux sodium injection
Duloxetine hydrochloride (Tentative approval)
Cevimeline (Tentative approval)
Pregabalin (Tentative approval)
Olopatadine (Tentative approval)
Levaquin
Ancobon
Arixtra
Cymbalta
Evoxac
Lyrica
Pataday/Patanol
 Newly Approved Drugs
 Drug Information Question
 How Safe are your Herbal Supplements?
 Apps of the Month
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Express Scripts Drug Information & Wellness Center
Volume 3 Issue 5
Newly Approved Drugs
Nulojix (belatacept) IV injection by Bristol-Myers Squibb (approved 6/15/11)
Class: T-cell costimulation blocker
Indication: prophylaxis of organ rejection in Ebstein-Barr Virus seropositive kidney transplant recipients, used concomitantly with basiliximab,
mycophenolate, and corticosteroids
MOA: Fusion protein which acts as a selective T-cell (lymphocyte) costimulation blocker by binding to CD80 and CD86 receptors on antigen presenting cells (APC), blocking the required CD28 mediated interaction between APCs and T cells needed to activate T lymphocytes. T-cell stimulation results in production of mediators in the immunologic rejection associated with kidney transplantation.
Dosing: Based on Actual Body Weight and rounded to the nearest 12.5 mg
Initial: 10 mg/kg on days 1 and 5, and end of weeks 2, 4, 8, and 12 after transplant.
Maintenance: 5 mg/kg every 4 weeks (+/- 3 days) beginning week 16.
Arcapta Neohaler (indacaterol) oral inhaler by Novartis (approved 7/1/11)
Class: β2 adrenergic agent (long acting bronchodilator)
Indication: COPD
MOA: agonist at β2 receptors in the airways, relaxes airway smooth muscles
Dosing: 75 mcg by inhalation once daily
Xarelto (Rivaroxaban) oral tablet by Johnson & Johnson (approved 7/1/11)
Class: Factor Xa inhibitor
Indication: postoperative thomboprophylaxis in patients who have undergone hip or knee surgery
MOA: Factor Xa inhibition results in inhibition of platelet activation and fibrin clot formation
Interactions: Avoid concurrent use with other anticoagulants, avoid concurrent use with clopidogrel unless benefits outweigh the bleeding risk.
Avoid using with combined P-gp and CYP3A4 inducers or inhibitors
Dosing: Therapy should not be initiated until at least 6-10 hours after surgery, once hemostasis has been established.
Knee Replacement: 10 mg orally once daily for 12-14 days Hip Replacement: 10 mg orally once daily for 35 days
Recent Guideline Updates
Centers for Disease Control (CDC)- Prevention of intravascular catheter-related infections
Guidelines for the prevention of intravascular catheter-related infections. Clin Infect Dis. 2011 May;52(9):e162-93.
Centers for Disease Control (CDC)- Combined oral contraceptive use in postpartum women
Update to CDC's U.S. Medical Eligibility Criteria for Contraceptive Use, 2010: Revised Recommendations for the Use of
Contraceptive Methods During the Postpartum Period.
Updates include: Combined hormonal contraceptives should not be used during the first 21 days after delivery due to the high
risk for VTE. During 21--42 days postpartum, women without risk factors for VTE can initiate combined hormonal contraceptives, but women with risk factors for VTE should not use these methods. After 42 days postpartum, no restrictions apply.
Infectious Diseases Society of America (IDSA)- Antimicrobial use in neutropenic cancer patients
Infectious Diseases Society of America; Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with
cancer: 2010 update by the Infectious Diseases Society of America. Clin Infect Dis. 2011 Feb 15;5(4):e56-93
Updates include: Categorizing patients into high risk or low risk for infections to better determine which patients will benefit most
from antimicrobial therapy.
Infectious Diseases Society of America (IDSA)- Intra-abdominal infections
Infectious Diseases Society of America; Guidelines for the selection of anti-infective agents for complicated Intra-abdominal
infections. Clin Infect Dis. 2010, 50: 133–164
Updates include: Addition of recommendations for managing intra-abdominal infection in children, for appendicitis in patients of all ages,
and for necrotizing enterocolitis in neonates.
Infectious Diseases Society of America (IDSA)- MRSA infections
Infectious Diseases Society of America; Management of Patients with Infections Caused by Methicillin-Resistant Staphylococcus
Aureus: Clinical Practice Guidelines by the Infectious Diseases Society of America (IDSA) Clin Infect Dis. 2011;1–38
Updates Include: These are the IDSA’s first MRSA guidelines, and discuss the management of a variety of clinical syndromes
associated with MRSA disease and provide recommendations regarding vancomycin dosing and monitoring, Also includes
management of infections due to MRSA strains with reduced susceptibility to vancomycin and treatment failures.
The Endocrine Society– Vitamin D deficiency
The Endocrine Society; Evaluation, treatment, and prevention of vitamin D deficiency: an endocrine society clinical practice
guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30.
Volume 3 Issue 5
Page 3
Drug Information Question
Will tinnitus resulting from furosemide use go away, or is it permanent?
A search through Micromedex found that ototoxicity (tinnitus, hearing loss) has been reported with oral/IV furosemide.
Most reported cases have been reversible, but permanent damage has occurred.
Upon searching in Drug-Induced Diseases by Tisdale and Miller it was found that when loop diuretics are used alone they
generally only cause temporary hearing loss, and that they can potentiate the toxicity of other ototoxic agents. Ototoxicity has been
reported to occur in 3-6.4%, and 50-100% (when injected rapidly) of furosemide treated patients. Thus, drug-induced ototoxicity
usually occurs more often in patients receiving furosemide intravenously than orally. The exact method of furosemide-induced tinnitus is unknown, but may be due to disruption of either endocochlear fluid homeostasis or endolymph homeostasis.1
A search in Meyler’s Side Effects of Drugs found that high doses of furosemide with serum concentrations over 50 mcg/ml
could cause tinnitus, sometimes being permanent. High tone deafness has been reported to occur in 6.4% of furosemide treated
patients.2
A search in PubMed located many articles that cited furosemide-induced ototoxicity. However, only a few articles had
specific time frames of how long ototoxicity remains after drug discontinuation. Schwartz et al. reported ototoxic effects in 5 patients with impaired renal function from high dose IV furosemide therapy. The ototoxic effects consisted of hearing loss in 4 patients and tinnitus in 2 patients. These adverse effects were temporary, and complete recovery occurred in all patients within 5
hours from drug discontinuation.3 Gallagher and Jones stated that The Adverse Drug Reaction Reporting Program of the FDA received 29 case reports of deafness attributed to the administration of furosemide out of 878 total reports. Most of these patients had
either impaired renal function or were also taking other drugs with ototoxic potential. Ages ranged from 20-76 years old, and doses
ranged from 40 mg to 21.6 g. Most patients experienced temporary hearing loss that lasted 30 minutes to 24 hours, and only 3
patients experienced permanent hearing loss.4
In conclusion, most reported cases of tinnitus have been transient and occurred in patients with renal dysfunction and/or
taking multiple ototoxic drugs. However, permanent damage has occurred in some patients. When furosemide has been discontinued for over 2 weeks and ototoxicity remains, there were no reports found indicating if tinnitus would subside or not. All patients
who had transient ototoxicity due to furosemide reported cessation of these effects within one day of furosemide discontinuation.
References
1. Miller M, Blankenship CS. Ototoxicity. In: Tisdale JE, Miller DA, editors. Drug-induced diseases. Maryland: American Society of Health System Pharmacists;2010 .p.1049-1058.
2. Aronson JK. Meyler’s Side Effects of Drugs.15th ed. Amsterdam: Elsevier;2006. p.1455.
3. Schwartz GH, David DS, Riggio RR, Stenzel KH, Rubin AL. Ototoxicity induced by furosemide. N Engl J Med, 1970;282(25):1413-4.
4. Gallagher KL, Jones JK. Furosemide-induced ototoxicity. Ann Intern Med. 1979 Nov;91(5):744-5.
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Express Scripts
Drug Information & Wellness Center
Southern Illinois University Edwardsville
Volume 3 Issue 5
Monday — Friday
8 a.m. — 4 p.m.
(618) 650-5142
Apps of the Month
The following applications for smartphones have been reviewed and critiqued by students and pharmacists:
Name
First Consult
Cost
Content
Free with subscription to MD 
Consult
Provides summaries of
medical topics including
diagnosis, treatment, and
evidence
Alt Meds
Free

Provides alternative
medication information
MyFitnessPal
Free

Calorie counter and fitness tracker that contains
a large food database
PubMed LITE
Free
*Full version is available for
$2.99

Searches PubMed to find
& display reference information
Lexi-Complete
$285
(Student & faculty
price=$175)

Great comprehensive
source for medical and
drug information

Drug information resource with pill images
& dosing calculators

Blood pressure tracking
and analysis tool

Provides emergency contact information when
you cannot

Provides prescription &
OTC drug information,
and drug interactions

Helps you choose a
snack based on how
many calories you want
Skyscape
RxDrugs
Free
iBP
$0.99
*Must purchase cuff
separately: $129
ICE
Free
Monthly
Prescribing
Reference
Free
The Snack App
Free
Rating (1-5)