FDA Announces Phased Withdrawal of Raptiva

On April 8, 2009, Genentech, the manufacturer of the psoriasis drug Raptiva (efalizumab), announced that it has begun a voluntary, phased withdrawal of the product from the U.S. market. The company is taking this action because of a potential risk to patients of developing progressive multifocal leukoencephalopathy (PML), a rare, serious, progressive neurologic disease caused by a virus that affects the central nervous system. By June 8, 2009, Raptiva will no longer be available in the United States.

Resistance to oseltamivir

Resistance to oseltamivir by specific strains of influenza have been reported. Check the CDC for the most current information and guidance at http://www.cdc.gov/flu/professionals/antivirals/

FDA Withraws Pergolide (Permax)

The companies that manufacture and distribute pergolide have agreed to withdraw this drug from the market due to the potential for heart valve damage. Two new studies showed that patients with Parkinson's disease who were treated with pergolide had an increased chance of serious damage to their heart valves when compared to patients who did not receive the drug. Pergolide is a member of a class of drugs known as dopamine agonists and is used with levodopa and carbidopa to manage the signs and symptoms (tremors and slowness of movement) of Parkinson's disease. See http://www.fda.gov/cder/drug/advisory/pergolide.htm

FDA Announces Discontinued Marketing of GI Drug, Zelnorm, for Safety Reasons

Novartis, in compliance with an FDA request, has suspended marketing and sales of its irritable bowel/constipation drug Zelnorm (tegaserod maleate), after an analysis of its clinical database pointed to a higher incidence of MI, stroke, and unstable angina among patients taking the drug. See: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01597.html

FDA Announces Label and Indication Changes for the Antibiotic Ketek

The Food and Drug Administration (FDA) announced revisions to the labeling for the antibiotic Ketek (telithromycin) designed to improve the safe use of Ketek by patients. The changes include the removal of two of the three previously approved indications — acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis — from the drug's label. The agency has determined that the balance of benefits and risks no longer support approval of the drug for these indications. Ketek will remain on the market for the treatment of community acquired pneumonia of mild to moderate severity (acquired outside of hospitals or long-term care facilities).

In addition, the agency has worked with the company, Sanofi Aventis, to update the product labeling with a “boxed warning,” FDA's strongest form of warning. The warning states that Ketek is contraindicated (should not be used) in patients with myasthenia gravis, a disease that causes muscle weakness.

For more information go to http://www.fda.gov/bbs/topics/NEWS/2007/NEW01561.html.

FDA aware of potential safety issue related to Avandia (rosiglitazone)

Warning Strengthened on Heart Failure Risk for Entire Class of Thiazolidinedione Class of Antidiabetic Drugs

August, 2007: FDA has determined that an updated label with a boxed warning on the risks of heart failure is needed for the entire thiazolidinedione class of antidiabetic drugs. This class includes Avandia (rosiglitazone), Actos (pioglitazone) Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepride).

FDA's review of adverse event reports found cases of significant weight gain and edema—warning signs of heart failure. In some reports, FDA noted, continuation of therapy has been associated with poor outcomes, including death. The strengthened warning advises health care professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy. Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered. People who have questions should contact their health care providers to discuss alternative treatments.

The warning also states that these drugs should not be used by people with serious or severe heart failure who have marked limits on their activity and who are comfortable only at rest or who are confined to bed or a chair.

For additional information:
Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl): http://www.fda.gov/cder/drug/infopage/rosiglitazone/default.htm
Pioglitazone HCl (marketed as Actos and Duetact): http://www.fda.gov/cder/drug/infopage/pioglitazone/default.htm