FDA MedWatch – Intelence (etravirine):Reports of severe, potentially life-threatening and fatal skin reactions

Tibotec Therapeutics and FDA notified healthcare professionals of revisions to the WARNINGS AND PRECAUTIONS section of the prescribing information for Intelence (etravirine). There have been postmarketing reports of cases of Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme, as well as hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including hepatic failure. Intelence therapy should be immediately discontinued when signs and symptoms of severe skin or hypersensitivity reactions develop.

CLICK HERE to read the complete MedWatch 2009 Safety Summary, including a link to the Dear healthcare professional letter.

American Recovery and Reinvestment Act (ARRA)

A significant number of Vanderbilt faculty have received award notices for various projects funded through ARRA (American Recovery and Reinvestment Act). If you are one of the awardees and your project includes human subjects, please note that we have become aware that the various federal agencies have placed some extremely stringent timelines for IRB approval as funds must be released by a 9/27/2009 deadline. Some agencies are giving 9/4/2009 as the date that IRB approval must be complete. Thus, to help expedite your study through the review process, please designate your funder as ARRA in your application. A couple of other tips that will help expedite your proposal is a thorough complete application and making yourself available for quick resolution of issues/concerns. Please call us at (615) 322-2918 before you submit if you have any questions or concerns.

FDA MedWatch – Levemir Insulin (Novo Nordisk): Stolen vials still may be on market

[UPDATED 08/26/2009] FDA is reminding the public that stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. still may be on the market. Evidence gathered to date suggests that the stolen insulin was not stored and handled properly and may be dangerous for people to use. FDA has received multiple reports of patients who suffered an adverse event due to poor control of glucose levels after using a vial from one of the stolen lots.

CLICK HERE to read the complete MedWatch 2009 Safety summmary including a link to the FDA News release and the original June 13,2009.

FDA MedWatch – July 2009 Drug Safety Labeling Changes

The MedWatch July 2009 Drug Safety Labeling Changes posting includes 38 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.

The Summary Page provides a listing of drug names and safety labeling sections revised.

Clicking on a drug product name in the Summary View will take you to the “detailed view” page, which identifies safety labeling sections and subsections revised, along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections.

The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and WARNINGS sections:

Chantix (varenicline), Wellbutrin (bupropion hydrochloride), Zyban (bupropion hydrochloride), Diabeta (glyburide), Lopid (gemfibrozil), Ortho Evra (norelgestromin/ethinyl estradiol) transdermal system, Veramyst (fluticasone furoate), Actonel (risedronate sodium), Gardasil (Human Papillomavirus Quadrivalent Types 6, 11, 16, 18) Recombinant Vaccine, Letairis (ambrisentan), Myfortic (mycophenolic acid), Rilutek (riluzole), Soliris (eculizumab)

FDA MedWatch – Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 [Dräeger/Hill-Rom]

[UPDATED 08/25/2009; original alert 07/22/2009] FDA notified healthcare professionals of a Class 1 recall of these models of the Stabilet infant warmer because these out-of-date devices may cause serious injury to infants and caregivers due to the possibility that the warmer might be the ignition source for a fire. On July 20, 2009, Draeger sent a recall letter to all known customers, requested customers remove the affected devices from service, remove the heating element and the power cord to make the device unusable once removed from service and emphasized these devices are not to be used, donated or sold for any other purpose. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

CLICK HERE to read the complete MedWatch 2009 Safety summmary including the July 22 alert and a link to the FDA recall notice and firm recall letter.

FDA MedWatch – Orlistat (marketed as Alli and Xenical): Early Communication about an Ongoing Safety Review

FDA notified healthcare professionals and patients that it is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat. Orlistat is marketed in the United States as a prescription product, Xenical, and as an over-the-counter (OTC) product, Alli. Between 1999 and October 2008, 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat were submitted to FDA’s Adverse Event Reporting System. The most commonly reported adverse events described in the 32 reports of serious liver injury were jaundice, weakness, and abdominal pain. FDA is reviewing other data on suspected cases of liver injury submitted by the manufacturers of orlistat, analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time. FDA is not advising healthcare professionals to change their prescribing practices with orlistat. Consumers currently taking Xenical should continue to take it as prescribed and those using over-the-counter Alli should continue to use the product as directed.

FDA urges both healthcare professionals and consumers to report side effects from the use of orlistat (Alli and Xenical) to FDA’s MedWatch Adverse Event Reporting program.

CLICK HERE to read the complete MedWatch Safety summary, including links to the Early Communication and FDA News Release.

FDA MedWatch – Accusure Insulin Syringes [31G, 1/2 cc and 1 cc]

Qualitest Pharmaceuticals and FDA notified patients and healthcare professionals of a voluntary nationwide recall of two lots of Accusure Insulin Syringes. The syringes in these lots have been found to have needles which can detach from the syringe. When the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after an injection. Consumers who have any recalled Accusure Insulin Syringes (31 G –Short Needle-either 1/2 cc or 1 cc, lot number 6JCB1 or lot number 7CPT1) should stop using them and contact Qualitest at 1-800-444-4011 for product replacement instructions. The lot number can be found on the white paper backing of each individual syringe. These recalled products were distributed from January 2007 through June 2008 to wholesalers and retail pharmacies nationwide (including Puerto Rico).

CLICK HERE to read the complete MedWatch 2009 Safety summmary including a link to the firm press release.

FDA MedWatch – Ibuprofen (Unapproved) topical drug products

FDA informed consumers and healthcare professionals of its intent to take action against eight companies that market unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen. The products, which contain ibuprofen in combination with a variety of other active ingredients and are marketed for pain relief, are unapproved new drugs that require an approved new drug application in order to be legally marketed. Orally administered ibuprofen has been approved as a safe and effective treatment for pain and inflammation. There are no approved applications for topical ibuprofen products. Topical ibuprofen is often promoted as a “safer” alternative that can be used in place of oral ibuprofen because of certain side effects, such as stomach ulcers and cardiovascular effects that are associated with prolonged use of oral ibuprofen. However, these safety claims for topical ibuprofen have not been reviewed by the FDA, nor has the agency evaluated what side effects might be associated with such products.

The names of the products and manufacturers that received warning letters are:
Emuprofen (Progressive Emu, Inc.)
BioEntopic 15% Ibuprofen Crème (BioCentric Laboratories, Inc.)
Ibunex Topical Ibuprofen (Core Products International, Inc.)
LoPain AF 15% Ibuprofen Crème (Geromatrix Health Products)
IB-RELIEF (MEKT LLC)
Profen HP (Ridge Medical Products)
IbuPRO-10 Plus (Meditrend, Inc. dba Progena Professional Formulations)
IBU-RELIEF 12 (Wonder Laboratories)

CLICK HERE to read the complete MedWatch 2009 Safety summary including a link to the FDA press release.

FDA MedWatch – Hospira, Inc. Device Recall

Hospira and FDA notified healthcare professionals and patients of a nationwide recall of devices that have defective AC power cords in response to customer reports of sparking, charring and fires on the plug of the power cord. Hospira’s investigation of these reports determined that the power cord’s prongs may crack and fail at or inside the plug. The potential risks from this power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires which may also occur in an oxygen-rich environment. Depending on the device and therapy, these failures may lead to potential serious injury or death.

Users with affected power cords that have bent or cracked prongs, burnt plastic or excessive wear and tear should discontinue use immediately and contact their Hospira sales representative or Hospira Technical Support Operations at 1-800-241-4002 (available from 6 a.m. to 4 p.m., Pacific time) for instructions on receiving replacement parts or devices.

CLICK HERE to read the complete MedWatch 2009 Safety summary, including a link to the firm press release.

FDA MedWatch – Dextroamphetamine, Amphetamine 20mg Tablets

Barr Laboratories, Inc. issued a voluntary recall of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single Entity Amphetamine Product) 20mg Tablets, 100 count bottles, lot number 311756. The product is being recalled because the affected lot may contain some tablets exceeding weight requirements which may lead to super-potent tablets.

Clinically significant adverse reactions to a supratherapeutic dose could include cardiovascular, neurologic, psychiatric and gastrointestinal reactions. Customers who have this lot in their possession are instructed to cease using the product and return it to their pharmacy/distributor.

CLICK HERE to read the MedWatch safety summary, including a link to the firm’s Press Release.