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FDA Changes Ketek Label, Removes Two Indications

Ketek should not be used to treat acute bacterial sinusitis or acute bacterial exacerbations of chronic bronchitis

MONDAY, Feb. 12 (HealthDay News) -- The U.S. Food and Drug Administration has stepped up the warning label for Ketek (telithromycin), and removed two of the three indications for the antibiotic. A joint advisory committee met in December and concluded that the risks of the drug outweigh the benefits for acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis. Ketek can still be used to treat mild-to-moderately severe community-acquired pneumonia.

The drug now has a "boxed warning" noting that it is contraindicated in patients with myasthenia gravis. There are also updated warnings on the risk of visual disturbances and loss of consciousness, in addition to the hepatic toxicity warning added in June 2006. A Patient Medication Guide, developed by the FDA and manufacturer Sanofi Aventis, will now be given with each prescription.

"Today's action is the result of comprehensive scientific analysis and thoughtful public discussion of the data available for Ketek, and includes important changes in the labeling designed to improve the safe use of Ketek by patients and give health care providers the most up-to-date prescribing information," said Steven Galson, M.D., director of the FDA's Center for Drug Evaluation and Research, in a statement.

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