FDA Asks If Antibiotic Ketek Worth RisksDec 15, 2006 | AP
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.
If the outside advisers recommend keeping the drug on the market, FDA said it would then ask whether the drug's label should be further updated to ensure the safe use of the drug - or if more studies are needed.
The label of the drug already was changed in June to add a bold-type warning about the rare reports of liver failure and severe injury, some of them fatal.
The FDA's handling of Ketek remains under investigation by a Senate committee. Sen. Charles Grassley, R-Iowa, said this week the FDA intentionally withheld information from FDA advisers when they met in 2003 to consider recommending approval of the drug. FDA officials declined to comment Thursday on his allegations.
Sanofi-Aventis said the risks associated with the drug, also known as telithromycin, appear to be comparable to those of other similar drugs and that it represents an important option in treating respiratory tract infections.