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news.The FDA has revised the labeling of Sanofi-Aventis' antibiotic Ketek by removing its use as a treatment for sinusitis and bronchitis because of safety issues with the drug.
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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 mild to moderate community of acquired pneumonia.
In addition, the agency has worked with Sanofi-Aventis to update the product labeling with a “boxed warning,” the FDA’s strongest form of warning. The warning states that Ketek is contraindicated and therefore should not be used in patients with myasthenia gravis, a disease that causes muscle weakness.
The agency also worked with the manufacturer to develop a Patient Medication Guide that informs patients about the risk of the drug and how to use it safely.
Other labeling changes included are a strengthened warning section regarding specific drug-related adverse events including visual disturbances and loss of consciousness. Warnings for hepatic toxicity were strengthened in June 2006.