FDA: New Limits to Ketek Use

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ketekFebruary 13, 2007 — Multiple label revisions for telithromycin (Ketek tablets, made by Sanofi-Aventis) include removal of its approval for 2 of its 3 indications, according to the US Food and Drug Administration (FDA).

The risks of telithromycin for the treatment of acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis have been found to outweigh the benefits, the FDA said in an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program.

Other label changes include a boxed warning stating that use of telithromycin is contraindicated in patients with myasthenia gravis, and a strengthened warning section regarding the risk for adverse events such as visual disturbances and loss of consciousness; the risk for hepatotoxicity was previously emphasized in June 2006.

In addition, a patient medication guide has been developed to inform patients regarding the risks and safe use of telithromycin. The information sheet will be dispensed with each prescription.

According to an FDA news release, the revisions were based on comprehensive scientific analysis and thoughtful public discussion of available data and are consistent with December 2006 recommendations from a joint panel of the FDA's Anti-Infective Drugs and Drug Safety and Risk Management Advisory committees.

Telithromycin remains approved only for the treatment of mild to moderate cases of community-acquired pneumonia.

Healthcare professionals are encourage to report telithromycin-related adverse events to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.

source Medscape