FDA will review Ketek

On Dec. 14 and 15, FDA will be seeking advice from an expert panel on the safety of Ketek, an antibiotic made by Sanofi-Aventis. In 2004, FDA approved Ketek, which is used to treat acute chronic bronchitis, acute bacterial sinusitis, and community-acquired pneumonia in adults. But since then, researchers have reported cases of serious liver injury, liver failure, and deaths in patients taking the drug. Warnings about possible liver injury were added to Ketek's label in June. Sanofi had been conducting trials of Ketek for treatment of ear infections and tonsillitis in children, but those trials were halted in June. The advisory committee will be looking into whether the overall risk-benefit profile supports the continued marketing of Ketek. Ketek, or telithromycin, is the first FDA-approved antibiotic of the ketolide class. Separately, the Senate Finance Committee and the House Energy & Commerce Committee are investigating allegations of fraud in clinical trials of Ketek conducted before FDA approval.