Download MedWatch - Boca Medical Products, Inc

(6 months posted on site)
May 4, 2007
FDA Advises Manufacturers to Test Glycerin for Possible Contamination
The Food and Drug Administration has issued an advisory statement to manufacturers
that they test their glycerin for possible contamination. This advisory follows reports of
deaths in other countries attributed to Chinese drug counterfeiters’ substituting diethylene
glycol for glycerin. FDA has stated that it has “no reason to believe that the U.S. supply
of glycerin is contaminated with DEG.” Nonetheless, it recommends testing of glycerin
“due to the serious nature of this potentially fatal problem.” The Board of Pharmacy
recommends that compounding pharmacies and other pharmacies that use glycerin heed
FDA’s advisory statement and take any action they deem appropriate.
FDA MedWatch - The FDA Safety Information and Adverse Events Reporting Program
May 2, 2007
Re: Recall Of Compounded Injectable Colchicine- All Strengths, Sizes and Lots
ApothéCure and FDA notified all healthcare professionals of recent deaths associated
with the use of compounded injectable Colchicine .5mg/ml, 4ml vials, lot number
20070122@26. The company issued an immediate drug recall for all strengths, sizes and
lots of compounded Injectable Colchicine sold within the last year. Customers are asked
to examine their stock for ApothéCure compounded Colchicine on hand and to
discontinue use immediately and prepare the product to return to the company.
Read the complete 2007 MedWatch 2007 Safety summary, including a link to the
Manufacturer's Recall Notice and Return Fax Cover Sheet regarding this issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Colchicine
FDA MedWatch - The FDA Safety Information and Adverse Events Reporting Program
May 1, 2007
Re: Warning About Counterfeit Drugs From Multiple Internet Sellers
FDA informed consumers and healthcare professionals regarding the dangers associated
with buying prescription drugs over the internet. FDA received information showing that
24 apparently related websites may be involved in the distribution of counterfeit
prescription drugs. The website appear to be operated from outside the United States.
On three occasions during recent months, consumers obtained counterfeit versions of
Xenical 120 mg Capsules, a drug used to help obese individuals who meet certain weight
and height requirements to lose and maintain weight loss, from two different websites.
Instead of receiving Xenical, a product manufactured by Hoffmann-LaRoche Inc,
consumers received sibutramine, the active ingredient in Meridia. Although Meridia is
also used to lose and maintain weight loss, the drug should not be used in certain patient
populations and is not a substitute for other weight loss products. Consumers should be
wary if there is no way to contact the website pharmacy by phone, if prices are
dramatically lower than the competition, or if no prescription from their doctor is
required. Additionally, consumers are urged to review the FDA web page at
www.fda.gov/buyonline for additional information prior to making purchases of
prescription drugs over the internet. See FDA press release for the list of the 24 web site
that may be involved in the distribution of counterfeit prescription drugs.
Read the complete 2007 MedWatch 2007 Safety summary, including a link to the FDA
Press Release regarding this issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Counterfeit
FDA MedWatch - The FDA Safety Information and Adverse Events Reporting Program
April 24, 2007
Re: Worldwide recall of approximately 300,000 S8 flow generators (Continuous Positive
Air Pressure or CPAP) - Recall due to potential for a short circuit in the power supply
connector
ResMed and FDA notified consumers and healthcare professionals of a worldwide recall
of approximately 300,000 S8 flow generators (Continuous Positive Air Pressure or
CPAP) used for the treatment of obstructive sleep apnea. In Model S8 devices
manufactured between July 2004 and May 15, 2006, there is a potential for a short circuit
in the power supply connector. ResMed plans to work with its distribution partners
globally to provide a replacement device to patients who have an affected S8 flow
generator. See recall notice for serial numbers for affected S8 models.
Patients may continue to use their S8 flow generators until they receive a replacement
device. As with any electrical device, patients should make sure that it is placed on a hard
clean surface and that the area around the device is clear during use. Patients should
discontinue use of the device if there are any signs of electrical failure such as
intermittent power, cracking sounds, sparking or charred smell. Patients should not use
supplemental oxygen with an affected device; patients using supplemental oxygen should
immediately contact their home healthcare provider for a replacement.
Read the complete MedWatch 2007 safety summary, including a link to the
manufacturer's Recall Notice, at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#ResMed
April 10, 2007
Urgent Recall Notice
Griseofulvin Oral Suspension (microsize) 125mg/5ml
NDC #10147-0810-4
Distributor - Patriot Pharmaceuticals
Manufacturer - Ortho-McNeil Pharmaceutical
Reason for recall - amber glass bottles enclosed in a plastic film from top of the cap to the
base. The over-wrap could potentially mask structural damage to the bottles and potential
glass fragments might be in the suspension.
For questions and lot numbers call 1-800-510-0383
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/04-102007/0004562317&EDATE=
FDA MedWatch - The FDA Safety Information and Adverse Events Reporting Program
April 6, 2007
Re: Tigan (trimethobenzamide hydrochloride) - Product Market Withdrawal Due to Lack
of Evidence of Effectiveness
FDA notified healthcare professionals and consumers that companies must stop
manufacturing and distributing unapproved suppository drug products containing
trimethobenzamide hydrochloride. These products are used to treat nausea and vomiting
in adults and children. The products have been marketed under various names, including
Tigan, Tebamide, T-Gen, Trimazide, and Trimethobenz. Drugs containing
trimethobenzamide in suppository form lack evidence of effectiveness. This action does
not affect oral capsules and injectable products containing trimethobenzamide that have
been approved by FDA.
FDA urges consumers currently using trimethobenzamide suppositories or who have
questions or concerns to contact their healthcare professional. Alternative products
approved to effectively treat nausea and vomiting are available in a variety of forms.
Read the complete MedWatch 2007 Safety summary, including a link to the FDA Press
Release regarding this issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#trimethobenzamide
FDA MedWatch - The FDA Safety Information and Adverse Events Reporting Program
March 28, 2007
Re: Dangers involved with buying Accutane (isotretinoin) online
FDA notified consumers and healthcare professionals of a special webpage launched to
warn about the dangers of buying isotretinoin online.
Isotretinoin is a drug approved for the treatment of severe acne that does not respond to
other forms of treatment. If the drug is improperly used, it can cause severe side effects,
including birth defects. Serious mental health problems have also been reported with
isotretinoin use.
The new webpage, http://www.fda.gov/buyonline/accutane, will appear in online search
results for Accutane (isotretinoin) or one of the generic versions, Amnesteem, Claravis,
and Sotret. The webpage warns that the drug should only be taken under the close
supervision of a physician or a pharmacist, and provides links to helpful information. The
new webpage is in addition to special safeguards put in place by FDA and manufacturers
of isotretinoin to reduce the risks of the drug, including a risk management program
called iPLEDGE. The aim of iPLEDGE is to ensure that women using isotretinoin do not
become pregnant, and that women who are pregnant do not use isotretinoin.
Read the complete MedWatch 2007 Safety summary, including a link to the FDA
Accutane Product Information Page regarding this issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Accutane
FDA MedWatch - The FDA Safety Information and Adverse Events Reporting Program
March 19, 2007
Re: V.MAX supplement product recalled
Barodon SF and FDA notified consumers and healthcare professionals of a voluntary
nationwide recall of a supplement product sold under the name V.MAX. Lab analysis by
FDA of product samples found the product contains Aminotadalafil, an analogue of
Tadalafil, an FDA-approved drug used to treat Erectile Dysfunction (ED).
FDA advised that this poses a threat to consumers because Aminotadalafil may interact
with nitrates found in some prescription drugs (such as nitroglycerin) and may lower
blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high
cholesterol, or heart disease often take nitrates.
Consumers who have V.MAX in their possession should stop using it immediately and
contact their physician if they experienced any problem that may be related to taking this
product.
Read the complete MedWatch 2007 Safety summary, including a link to the firm press
release, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#vmax
FDA MedWatch - The FDA Safety Information and Adverse Events Reporting Program
March 16, 2007
Re: Rhino Max supplement product recalled
Cosmos Trading, Inc. and FDA notified consumers and healthcare professionals of a
voluntary nationwide recall of a supplement product sold under the name Rhino Max
(Rhino V Max) in 5-tablet boxes or 15-tablet boxes. Lab analysis by FDA of product
samples found the product contains Aminotadalafil, an analogue of Tadalafil, an FDAapproved drug used to treat Erectile Dysfunction (ED).
FDA advised that this poses a threat to consumers because Aminotadalafil may interact
with nitrates found in some prescription drugs (such as nitroglycerin) and may lower
blood pressure to dangerous levels.
Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often
take nitrates. Consumers who have Rhino Max (Rhino V Max) in their possession should
stop using it immediately and contact their physician if they experienced any problem
that may be related to taking this product.
Read the complete MedWatch 2007 Safety summary, including a link to the firm's press
release, at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Rhino
FDA MedWatch - The FDA Safety Information and Adverse Events Reporting Program
February 21, 2007
Re: Xolair (omalizumab) - new reports of serious and life-threatening allergic reactions
(anaphylaxis)
FDA notified asthmatic patients and healthcare professionals of new reports of serious
and life-threatening allergic reactions (anaphylaxis) in patients after treatment with
Xolair. Usually these reactions occur within two hours of receiving a Xolair
subcutaneous injection. However, these new reports include patients who had delayed
anaphylaxis-with onset two to 24 hours or even longer-after receiving Xolair treatment.
Anaphylaxis may occur after any dose of Xolair (including the first dose), even if the
patient had no allergic reaction to the first dose.
Health care professionals who administer Xolair should be prepared to manage lifethreatening anaphylaxis and should observe their Xolair-treated patients for at least two
hours after Xolair is given. Patients under treatment with Xolair should be fully informed
about the signs and symptoms of anaphylaxis, their chance of developing delayed
anaphylaxis following Xolair treatment, and how to treat it when it occurs. FDA has
requested Genentech add a boxed warning to the product label and to revise the label and
provide a Medication Guide for patients.
Read the complete MedWatch 2007 Safety summary, including links to the Healthcare
Professional information sheet and FDA press statement, at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Xolair
February 15, 2007 Health Alert - FDA Issues Notice on RotaTeq Rotavirus Vaccine
FDA MedWatch - The FDA Safety Information and Adverse Events Reporting Program
February 7, 2007
Re: Heparin Sodium Injection 10,000 units/mL and HEP-LOCK U/P 10 units/mL
associated with fatal medication errors
Baxter and FDA notified healthcare professionals of the potential for life threatening
medication errors involving two Heparin products, Heparin Sodium Injection 10,000
units/mL, and HEP-LOCK U/P 10 units/mL.
Baxter is aware of fatal medication errors that have occurred when two Heparin products
with shades of blue labeling were mistaken for each other. Three infant deaths resulted
when the higher dosage Heparin Sodium Injection 10,000 units/mL was inadvertently
administered instead of the lower dosage of HEP-LOCK U/P 10 units/mL. The currently
marketed 1 mL vials of both Heparin products use blue as the prominent background
color on their labels.
Read the complete MedWatch 2007 Safety summary, including a link to the Baxter Dear
Healthcare Provider letter, at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Heparin
FDA MedWatch - The FDA Safety Information and Adverse Events Reporting Program
February 6, 2007
Re: Use of Skin Products Containing Numbing Ingredients (Topical Anesthetic Drugs)
for Cosmetic Procedures and Potential Life-Threatening Side Effects
FDA informed consumers and healthcare professionals of the potential hazards of using
skin numbing products containing topical anesthetic drugs such as lidocaine, tetracaine,
benzocaine, and prilocaine in a cream, ointment, or gel. Numbing products are widely
used to numb the skin for medical and cosmetic procedures, and to relieve pain, burning
and itching due to a variety of medical conditions. FDA has approved many of these
products for these uses. Some of these products must be prescribed by a doctor, others
may be purchased without a prescription.
FDA is aware that use of these products before a cosmetic procedure may not be
supervised by trained health professionals. Without this supervision, a patient may apply
large amounts of the numbing product to their skin, which can cause life-threatening side
effects and death. If a skin numbing product is prescribed or recommended for a
procedure, consumers should do the following:
- use a topical anesthetic approved by the FDA.
- use a topical anesthetic that contains the lowest amount of anesthetic drugs possible that
will relieve pain.
- ask for instructions from your doctor on how to safely use the topical anesthetic.
Read the complete MedWatch 2007 Safety summary, including the link to the FDA's
Public Health Advisory regarding this issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Anesthetics
Paxil CR® Recall Notice - January 23, 2007 - Read the recall notice here (includes lot
numbers and additional information.)
MedWatch - Boca Medical Products, Inc. Issues Nationwide Recall of Insulin Syringe
Product
May 19, 2006
Boca Medical Products and FDA notified consumers and healthcare professionals of an
extension of an earlier recall of Ultilet insulin syringes and the additional recall of
Closercare insulin syringes because of bacterial contamination with Paenibacillus. This
presents a risk of local infection due to soft tissue injection with a contaminated syringe
as well a risk of introduction of contaminating organisms into a previously sterile vial.
The introduced contamination may degrade the insulin, which could lead to problems
maintaining insulin levels. The recall includes Closercare Insulin Syringe 29g 1cc
product lot number 5JCZ1 as displayed on the inner case and Ultilet Insulin Syringe 30g
1/2cc, product lot number 5KEO1 as displayed on the inner case. The earlier recall of
Ultilet syringes included lot number 5GEXI. This product has been distributed to the
following states: FL, NY, MA, AL, SC, NC, CO, TX, MI, AR.
Read the complete MedWatch 2006 Safety summary, including links to the current and
past firm recall notices, at:
http://www.fda.gov/medwatch/safety/2006/safety06.htm#closercare
Spectrum Laboratory Products, Inc. Issues Nationwide Recall of Tacrolimus Active
Pharmaceutical Ingredient
May 11, 2006
FOR IMMEDIATE RELEASE -- Gardena, CA -- May 11, 2006 -- Spectrum Laboratory
Products, Inc, (Spectrum), Gardena, California, is initiating a voluntary nationwide recall
of the active pharmaceutical ingredient (API) tacrolimus after learning some lots are subpotent. Tacrolimus is an immunosuppressive drug used to prevent rejection of
transplanted solid organs such as heart or kidney. Blood levels of tacrolimus in some
patients were significantly lower than would be expected based solely on the lower assay
results. The use of sub-potent tacrolimus in compounded drugs for transplant recipients
may lead to sub-therapeutic tacrolimus blood levels and an unacceptably increased risk of
solid organ transplant rejection. At least one injury has been reported. FDA has been
apprised of this action.
To read the press release in its entirety,
visit: http://www.fda.gov/oc/po/firmrecalls/spectrum05_06.html
FDA MedWatch - Oral Sodium Phosphate Products for Bowel Cleansing: Risk of acute
phosphate nephropathy and renal failure
May 5, 2006
FDA notified healthcare professionals and consumers of reports of acute phosphate
nephropathy, a type of acute renal failure, that is a rare, but serious adverse event
associated with the use of oral sodium phosphates (OSP) for bowel cleansing.
Documented cases of acute phosphate nephropathy include 21 patients who used an OSP
solution (such as Fleet Phospho-soda or Fleet ACCU-PREP) and one patient who used
OSP tablets (Visicol). Individuals at increased risk of acute phosphate nephropathy
include: those of advanced age, those with kidney disease or decreased intravascular
volume, and those using medicines that affect renal perfusion or function [diuretics,
angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs),
and possibly nonsteroidal anti-inflammatory drugs (NSAIDs)]. Recommendations were
offered for providers and patients when choosing and using a bowel cleanser.
To read more, visit: http://www.fda.gov/cder/drug/infopage/osp_solution/default.htm
FDA Alert
April 26, 2006
Promethazine Contraindicated in Young Children
Medications containing promethazine hydrochloride (HCl) should not be used for
children less than two years of age because of the potential for fatal respiratory
depression. This includes promethazine HCl in any form: syrups, suppositories, tablets,
or injectables. Cases of respiratory depression including fatalities have been reported with
use of promethazine HCl in children less than two years of age. Caution should also be
exercised when administering promethazine HCl in any form to pediatric patients two
years of age and older. The labeling on all products, brand name and generic, has been
changed to reflect these strengthened warnings. One manufacturer of suppositories and
tablets has notified healthcare professionals of the changed label. The FDA is issuing this
safety alert to make sure that healthcare professionals, other caregivers, and patients
realize that the warnings apply to promethazine HCl syrups as well.
To read more, visit:
http://www.fda.gov/medwatch/safety/2006/safety06.htm#promethazine
Hollister-Stier Laboratories, LLC
April 20, 2006
Device Recall Notification
A device Recall Notification has been issued to all consignees that have purchased the
following product:
Sterile Empty Vial
10 mL size
Lot #6743
Item No's: 7515ZA; 7515ZC; 7515ZD
Click here for more information, including a Recall Response Form.
FDA Alert
April 2006
Diazepam Rectal Gel (marketed as Diastat AcuDial) Information
Cracks have been found in the applicator tips of the 10 and 20 mg Diastat AcuDial
prefilled syringes. Medicine can leak through the cracks. If medicine leaks, there may not
enough medicine to treat a seizure.
If you or someone in your care uses Diastat AcuDial, carefully check your pre-filled
syringes for cracks. You should check the syringes WITHOUT REMOVING THE CAP.
For instructions: visit http://www.diastat.com and click on the “Alert” Box to see photos,
or call Valeant Pharmaceuticals at 1-877-361-2719, about how to check for cracks.
If you see a crack, use a different syringe. Take all cracked syringes back to the
pharmacist and exchange them for new syringes. Cracks can appear over time, so keep
checking on your syringes to make sure you have good ones ready to use if needed.
If seizures continue after using Diastat, get emergency medical help right away by calling
911.
The company that makes Diastat AcuDial prefilled syringes is working to correct the
problem, but new syringes will not be available until June or July. Meanwhile, the old
prefilled syringes will still be dispensed because there is no other product available to
treat sudden increased seizures.
(from FDA: http://www.fda.gov/cder/drug/infopage/diazepam_RG/default.htm)
From the Food and Drug Administration
April 14, 2006
Media Inquiries: Press Office, 301-827-6242
Consumer Inquiries: 888-INFO-FDA
FDA Statement Regarding Voluntary Market Withdrawal of Bausch & Lomb ReNu
MoistureLoc® Contact Lens Solution
FDA is continuing to work closely with the Centers for Disease Control and Prevention
(CDC) and Bausch & Lomb to investigate the source of Fusarium keratitis eye infections.
The agency supports Bausch & Lomb's decision to voluntarily withdraw ReNu
MoistureLoc® contact lens solution from the market until the agencies have had a chance
to conclude their investigation.
FDA started its investigation of the Bausch & Lomb manufacturing plant on March 22,
2006, and will continue inspections of the Greenville, SC manufacturing plant and other
facilities through next week. While the investigation continues, FDA will work with CDC
to identify and confirm cases of Fusarium keratitis reported by state health departments
and from FDA Medwatch reports.
FDA and CDC are advising consumers to take precautions to reduce their risk for
Fusarium keratitis through preventive practices for contact lens wearers that include:
Wash hands with soap and water, and dry (lint-free method) before handling lenses.
Wear and replace lenses according to the schedule prescribed by the doctor.
Follow the specific lens cleaning and storage guidelines from the doctor and the solution
manufacturer.
Keep the contact lens case clean and replace every 3-6 months.
Remove the lenses and consult your doctor immediately if you experience symptoms
such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or
swelling.
For more information, please visit FDA’s Contact Lens and Eye Infections page at:
http://www.fda.gov/oc/opacom/hottopics/contacts.html
From the Food and Drug Administration
FOR IMMEDIATE RELEASE
March 31, 2006
Media Inquiries: Rae Jones, (301) 827-6242
Consumer Inquiries: 888-INFO-FDA
Permanent Court Order Halts Illegal Importation of Prescription Drugs
On March 9, 2006, the United States District Court for the Southern District of New York
entered a Consent Degree that permanently enjoins Canada Care Drugs, Inc. (Canada
Care), Christine Ruggiero, and Claire Ruggiero (defendants) from causing the
importation of drugs, receiving commissions from the importation of drugs, and
advertising or promoting any drug importation service.
Additional FDA inspections, as directed by the court order, will be used to ensure that the
defendants do not continue to violate the law. In addition, the court ordered the
defendants to surrender to the U.S. Treasury $4,000 in profits from their illegal activities.
"This court order is another example of the FDA's efforts to stop illegal drug imports – a
practice which can present a health hazard to patients," said Margaret O'K. Glavin,
Associate Commissioner for Regulatory Affairs. "Our agency will continue to help
protect Americans from potentially harmful consequences of this practice, while also
working to help assure that Americans have access to quality, safe, and effective
products."
The permanent injunction is the result of a legal process that started on November 9,
2004, when the federal government filed a civil complaint against these defendants based
on an FDA investigation of Canada Care's illegal importation operations. This consent
decree of permanent injunction follows one filed August 20, 2004 in the case of Rx
Depot and Rx of Canada, where the defendants were also ordered to cease all operations
involving the illegal importation of prescription drugs.
FDA's investigation, conducted in February and August, 2004, involved undercover
purchases of prescription medications through Canada Care. Medications purchased
outside the consumer safety protections built into the U.S. drug distribution system are a
public health concern because patients cannot be sure of the quality or the safety and
effectiveness of such drugs. In addition, as in the case of products purchased undercover
by FDA from Canada Care, these kinds of products are often shipped with inadequate
instructions for use or in inappropriate quantities that facilitate use of the product without
the input of a physician that is needed to assure that the product is used in a manner to
prevent serious, and even fatal, consequences.
In addition, previous FDA investigations found that drugs purchased under these
conditions are more likely to be contaminated, counterfeit, inherently ineffective, or
contain different amounts of the active ingredients from similar drugs that are FDA
approved and are safeguarded by the consumer protections built into the U.S. drug
distribution system.
For more information go to: www.fda.gov/bbs/topics/news/2004/NEW01142.html and
www.fda.gov/bbs/topics/ANSWERS/2004/ANS01337.html.
From the Department of Health and Human Services - Centers for Disease Control and
Prevention
CDC HEALTH ALERT
CDC Recommends against the Use of Amantadine and Rimantadine for the Treatment or
Prophylaxis of Influenza in the United States during the 2005–06 Influenza Season
Recent evidence indicates that a high proportion of currently circulating Influenza A
viruses in this country are resistant to these medications
Distributed via Health Alert Network
January 14, 2006, 3:25 PM EST
While the primary strategy for preventing complications of influenza infections is annual
vaccination, antiviral medications with activity against influenza viruses can be effective
for the prophylaxis and treatment of influenza. Two classes of antivirals are currently
available—the M2 ion channel inhibitors (i.e., the two adamantanes amantadine and
rimantadine) and the neuraminidase inhibitors (i.e., oseltamivir and zanamivir). The
neuraminidase inhibitors are effective for the treatment and prophylaxis of influenza A
and B, while the adamantanes are only active against influenza A viruses. This alert
provides new information about the resistance of influenza viruses currently circulating
in the United States to the adamantanes, and it makes an interim recommendation that
these drugs not be used during the 2005–06 influenza season. Amantadine is also used to
treat the symptoms of Parkinson’s disease, and should continue to be used for this
indication.
Viral resistance to adamantanes can emerge rapidly during treatment because a single
point mutation at amino acid positions 26, 27, 30, 31, or 34 of the M2 protein can confer
cross-resistance to both amantadine and rimantadine. The transmissibility of adamantaneresistant viruses is not impaired by any of these amino acid changes. A recent report on
the global prevalence of adamantane-resistant influenza viruses showed a significant
increase (from 1.9% to 12.3%) in drug resistance over the past 3 years. In the United
States, the frequency of drug resistance increased from 1.9% in 2004 to 14.5% during the
first 6 months of the 2004–05 influenza season.
For the 2005–06 season, 120 influenza A (H3N2) viruses isolated from patients in 23
states have been tested at CDC through January 12, 2006; 109 of the isolates (91%)
contain an amino acid change at position 31 of the M2 protein, which confers resistance
to amantadine and rimantadine. Three influenza A(H1N1) viruses have been tested and
demonstrated susceptibility to these drugs. All influenza viruses from the United States
that have been screened for antiviral resistance at CDC have demonstrated susceptibility
to the neuraminidase inhibitors.
On the basis of available antiviral testing results, CDC is providing an interim
recommendation that neither amantadine nor rimantadine be used for the treatment or
prophylaxis of influenza A in the United States for the remainder of the 2005–06
influenza season. During this period, oseltamivir or zanamivir should be selected if an
antiviral medication is used for the treatment and prophylaxis of influenza. Testing of
influenza isolates for resistance to antivirals will continue throughout the 2005–06
influenza season, and recommendations will be updated as needed. Annual influenza
vaccination remains the primary means of preventing morbidity and mortality associated
with influenza.
Additional information about the prevention and control of influenza is available at
www.cdc.gov/flu. Specific information regarding the use of the neuraminidase inhibitors
is available at www.cdc.gov/flu/protect/antiviral. These websites will be updated as new
information becomes available.
To read more, visit: http://www.cdc.gov/flu/han011406.htm and
http://www.guideline.gov/summary/summary.aspx?view_id=1&doc_id=8573
U.S. Food and Drug Administration
January 27, 2006
Media Inquiries:
Laura Alvey, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Approves First Ever Inhaled Insulin Combination Product for Treatment of
Diabetes
There is a new, potential alternative for many of the more than 5 million Americans who
take insulin injections, with the Food and Drug Administration's approval today of the
first ever inhaled insulin. Exubera, an inhaled powder form of recombinant human insulin
(rDNA) for the treatment of adult patients with type 1 and type 2 diabetes, is the first new
insulin delivery option introduced since the discovery of insulin in the 1920s.
"Until today, patients with diabetes who need insulin to manage their disease had only
one way to treat their condition," said Dr. Steven Galson, Director, Center for Drug
Evaluation and Research, FDA. "It is our hope that the availability of inhaled insulin will
offer patients more options to better control their blood sugars."
Diabetes is a disease that affects the amount of insulin and sugar in your body. Exubera is
a human form of insulin and as such, lowers blood sugar concentrations by allowing the
blood sugar to be taken up by cells as a source of fuel. Exubera is a powdered form of
insulin that is able to be inhaled into the lungs through the patient's mouth using a
specially designed inhaler.
There are two major types of diabetes -- type 1 and type 2. People with type 1 diabetes
produce virtually no insulin. In type 2, the most common form of the disease, the body
does not produce enough insulin or effectively use insulin. If people with diabetes do not
properly control their blood sugar levels, serious complications including heart disease,
kidney failure, blindness, and nerve damage may develop.
The safety and efficacy of Exubera have been studied in approximately 2500 adult
patients with type 1 and type 2 diabetes. In clinical studies, Exubera reached peak insulin
concentration more quickly than some insulins, called regular insulin, administered by an
injection. Peak insulin levels were achieved at 49 minutes (range 30 to 90 minutes) with
Exubera inhaled insulin compared to 105 minutes (range 60 to 240 minutes) with regular
insulin, respectively. In type 1 diabetes, inhaled insulin may be added to longer acting
insulins as a replacement for short-acting insulin taken with meals. In type 2 diabetes,
inhaled insulin may be used alone, along with oral (non-insulin) pills that control blood
sugar, or with longer acting insulins.
Exubera prescriptions will be accompanied by a Medication Guide containing FDAapproved information written especially for patients. Pharmacists are required to
distribute Medication Guides with products FDA has determined are important to health,
and patient adherence to directions for use is crucial to the product's effectiveness.
Patients are advised to read the entire Medication Guide and talk to their healthcare
provider if they have further questions.
Like any insulin product, low blood sugar is a side effect of Exubera and patients should
carefully monitor their blood sugars regularly. Other side effects associated with Exubera
therapy seen in clinical trials included cough, shortness of breath, sore throat, and dry
mouth.
Exubera is not to be used if you smoke or if you recently quit smoking (within the last 6
months). Exubera is not recommended in patients with asthma, bronchitis, or
emphysema. Baseline tests for lung function are recommended after the first 6 months of
treatment and every year thereafter, even if there are no pulmonary symptoms.
While Exubera has been extensively studied for safety, the sponsor has committed to
performing long-term studies to confirm the continued safety of Exubera after it is
marketed and to examine more thoroughly the issue of the efficacy and safety of Exubera
in patients with underlying lung disease.
Exubera is manufactured by Pfizer Inc., NY, NY.
http://www.fda.gov/bbs/topics/news/2006/NEW01304.html
U.S. Food and Drug Administration
January 20, 2006
The Food and Drug Administration announced the approval of updated labeling for two
topical eczema drugs, Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus).
Elidel Cream (pimecrolimus)
Protopic Ointment (tacrolimus)
The Food and Drug Administration announced the approval of updated labeling for two
topical eczema drugs, Elidel Cream (pimecrolimus) and Protopic Ointment (tacrolimus).
The labeling will be updated with a boxed warning about a possible risk of cancer and a
Medication Guide (FDA-approved patient labeling) will be distributed to help ensure that
patients using these prescription medicines are aware of this concern. The new labeling
also clarifies that these drugs are recommended
for use as second-line treatments. This means that other prescription topical medicines
should be tried first. Use of these drugs in children under 2 years of age is not
recommended.
Read the complete MedWatch 2006 Safety Summary, including links to the FDA Public
Health Advisory and the FDA Drug Information Page that includes links
to the Healthcare Professional and Patient Information Sheets, at:
http://www.fda.gov/cder/drug/infopage/elidel/default.htm
http://www.fda.gov/cder/drug/infopage/protopic/default.htm
U.S. Food and Drug Administration
January 18, 2006
Media Inquiries:
301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Announces New Prescription Drug Information Format to Improve Patient Safety
The U.S. Food and Drug Administration (FDA) today unveiled a major revision to the
format of prescription drug information, commonly called the package insert, to give
healthcare professionals clear and concise prescribing information. In an effort to manage
the risks of medication use and reduce medical errors, the newly designed package insert
will provide the most up-to-date information in an easy-to-read format that draws
physician and patient attention to the most important pieces of drug information before a
product is prescribed. The new format will also make prescription information more
accessible for use with electronic prescribing tools and other electronic information
resources.
Revised for the first time in more than 25 years, the new format requires that the
prescription information for new and recently approved products meet specific graphical
requirements and includes the reorganization of critical information so physicians can
find the information they need quickly. Some of the most significant changes include:
A new section called Highlights to provide immediate access to the most important
prescribing information about benefits and risks.
A Table of Contents for easy reference to detailed safety and efficacy information.
The date of initial product approval, making it easier to determine how long a product has
been on the market.
A toll-free number and Internet reporting information for suspected adverse events to
encourage more widespread reporting of suspected side effects.
To continue reading, please visit:
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01272.html
U.S. Food and Drug Administration
January 11, 2006
FDA Cautions Consumers Against Filling U.S. Prescriptions Abroad
Drugs With Same or Similar Names May Contain Different Active Ingredients Than in
U.S. and Pose Health Risks
http://www.fda.gov/bbs/topics/news/2006/NEW01295.html
The U.S. Food and Drug Administration (FDA) is warning healthcare professionals and
consumers that filling their prescriptions abroad may have adverse health consequences
because of confusion with drug brand names that could inadvertently lead consumers to
take the wrong medication for their condition. An FDA investigation has found that many
foreign medications, although marketed under the same or similar-sounding brand names
as those in the United States, contain different active ingredients than in the United
States. Taking a different active ingredient may not help, and may even harm, the user.
"Consumers who fill U.S. prescriptions abroad, either when traveling or when shopping
at foreign internet pharmacies, need to be aware of this potential health hazard," said Dr.
Murray Lumpkin, Deputy Commissioner for International and Special Programs. "The
name of a drug bought from another country may be identical or similar to the name on
the U.S. prescription, but the active ingredient in the medicine may be different and not
provide the right treatment."
FDA's investigation illustrates this health risk inherent in filling U.S. prescriptions abroad
and highlights the lack of standardization of drug trade names internationally. For
example, in the United States, "Flomax" is a brand name for tamsulosin, a treatment for
an enlarged prostate, while in Italy, the active ingredient in the product called "Flomax"
is morniflumate, an anti-inflammatory drug. In the United States, "Norpramin" is the
brand name for an anti-depression drug containing desipramine but, in Spain, the same
brand name, "Norpramin," is used for a drug that contains omeprazole, a treatment for
stomach ulcers. While some of the identical brand names have different active
ingredients appropriate for the same health condition, even these products should not be
substituted without the guidance of a healthcare professional because of the potential for
different doses, side effects, allergies, and interactions with other drugs.
FDA also has found 105 U.S. brand names that have foreign counterparts that look or
sound so similar that consumers who fill such prescriptions abroad may receive a drug
with the wrong active ingredient. For example, in the United Kingdom, "Amyben," a
brand name for a drug product containing amiodarone, used to treat abnormal heart
rhythms, could be mistaken for "Ambien," a U.S. brand name for a sleeping pill. Using
Amyben instead of Ambien could have a serious adverse outcome.
For more information, see FDA's Public Health Advisory at
http://www.fda.gov/oc/opacom/reports/confusingnames.html.