U.S. Food and Drug Administration Updates for Health Professionals
As part of the FDA’s efforts to keep health professionals informed about FDA issues, below is included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site.
PRODUCT SAFETY:
FDA Orders 2 Companies to Stop Marketing Unapproved Nitroglycerin Tablets (Mar. 16)
The FDA ordered Glenmark Generics of Mahwah, N.J., and Konec Inc. of Tucson, Ariz., to stop marketing unapproved nitroglycerin tablets. The tablets are placed under the tongue to relieve chest pain or to stop a heart attack and are marketed in 0.3 mg, 0.4 mg, and 0.6 mg dosages. The FDA does not anticipate a supply problem for these products. Pfizer Inc. markets FDA-approved sublingual nitroglycerin tablets in the same strengths and is able to supply the market with approved products.
FDA Announces New Boxed Warning on Plavix (Mar. 12)
The FDA added a boxed warning to the anti-blood clotting drug Plavix (clopidogrel), alerting patients and health care professionals that the drug can be less effective in people who cannot metabolize the drug to convert it to its active form. FDA hosted a media teleconference on March 12. A replay of the call is available through March 19, 2010 by calling 866-445-8304, passcode 4669.
FDA Approves Name Change for Heartburn Drug Kapidex (Mar. 4)
Change to Dexilant is part of FDA effort to prevent medication errors - The FDA has approved a name change for the heartburn drug Kapidex (dexlansoprazole) to avoid confusion with two other medications – Casodex and Kadian. Effective in late April 2010, Takeda Pharmaceuticals North America Inc. will market Kapidex under the new name Dexilant. Since Kapidex was approved in January 2009, there have been reports of dispensing errors because of confusion with the drugs Casodex (bicalutamide) and Kadian (morphine sulfate), which have very different uses from Kapidex and from each other.
PRODUCT APPROVALS:
FDA Approves Botox to Treat Spasticity in Flexor Muscles of the Elbow, Wrist and Fingers (Mar. 9)
The FDA approved Botox (onabotulinumtoxin A) to treat spasticity in the flexor muscles of the elbow, wrist, and fingers in adults. Spasticity is common after stroke, traumatic brain injury, or the progression of multiple sclerosis.
ANNOUNCEMENTS:
FDA Task Force Seeks Public Comments on Increasing Transparency with Regulated Industry
(Mar. 12)
As part of the final phase of its transparency initiative, the FDA is seeking comment from the public and other interested stakeholders on how the agency can increase transparency in its interactions with regulated industry. Posted in the March 12, 2010, Federal Register, the request for electronic or written comments has a deadline of April 12, 2010.
FDA MedWatch Mobile Text Messaging
The FDA recently launched a new MedWatch Safety Information mobile text message program. The content of the text messages will consist of alerts that provide timely new safety information on human drugs, medical devices, and related safety topics. The messages contain actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient. To subscribe to the pilot, text FDA to 87000. Subscribers can expect to receive approximately three to five text messages a week during the six-month pilot. Standard text messaging rates will apply.