Recommendations for Using Antiviral Agents for Influenza for the 2006-07 Influenza Season
(for more details see: http://www.cdc.gov/flu/professionals/treatment/)

Although annual vaccination is the primary strategy for preventing complications of influenza virus infections, antiviral medications with activity against influenza viruses can be effective for the chemoprophylaxis and treatment of influenza. Four licensed influenza antiviral agents are available in the United States: amantadine, rimantadine, zanamivir, and oseltamivir. Influenza A virus resistance to amantadine and rimantadine can emerge rapidly during treatment. On the basis of antiviral testing results conducted at CDC and in Canada indicating high levels of resistance, CDC and ACIP recommend that neither amantadine nor rimantadine be used for the treatment or chemoprophylaxis of influenza A in the United States until susceptibility to these antiviral medications has been re-established among circulating influenza A viruses. Oseltamivir or zanamivir can be prescribed if antiviral treatment of influenza is indicated. Oseltamivir is approved for treatment of persons aged >1 year, and zanamivir is approved for treatment of persons aged >7 years. Oseltamivir and zanamivir can be used for chemoprophylaxis of influenza; oseltamivir is licensed for use in persons aged >1 year, and zanamivir is licensed for use in persons aged >5 years.

Note: On November 13, 2006, FDA approved a labeling supplement for Roche Laboratories' Tamiflu (Oseltamivir Phosphate) to include a precaution about neuropsychiatric events. The revision is based on postmarketing reports (mostly from Japan) of self-injury and delirium with the use of Tamiflu in patients with influenza. The reports were primarily among pediatric patients. The relative contribution of the drug to these events is not known. However, people with the flu, particularly children, may be at an increased risk of self-injury and confusion shortly after taking Tamiflu and should be closely monitored for signs of unusual behavior. A healthcare professional should be contacted immediately if the patient taking Tamiflu shows any signs of unusual behavior. Visit http://www.fda.gov/medwatch/safety/2006/safety06.htm#tamiflu for more information.

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