FDA Panel Review of Ketek for Liver Problems

Article in the New York Times — FDA to Assess Antibiotic Linked to Woes, by the Associated Press:

Federal health officials said Thursday they would ask outside experts whether the benefits of an antibiotic linked to rare reports of severe liver problems, including several deaths, outweigh its risks.

A Food and Drug Administration review found 13 reports of liver failure in patients treated with the drug, Ketek, through September. Doctors have prescribed the antibiotic, made by France’s Sanofi-Aventis SA, more than 5.6 million times in the United States since the FDA approved it in 2004 to treat respiratory tract infections, bronchitis, sinusitis and community-acquired pneumonia.

Concerns about the rare but serious health problems seen in patients treated with the drug led the FDA to convene a two-day meeting of outside experts. The panel is expected to wrap up late Friday with a recommendation to the agency.

BGS