FDA Panel Pushes for Stronger Warning on Antibiotic Ketek

May 2006

After conducting a safety review of the Sanofi-Aventis antibiotic Ketek, the Food and Drug Administration (FDA) panel has linked the drug to 12 cases of liver failure, including four deaths. They are urging for a bold warning to be placed on the label stating that “severe, life-threatening, and in some cases fatal” liver toxicity has occurred in patients.

The report calls some of the liver-failure cases “clinically remarkable,” and liver injury was seen within a few days after patients took Ketek. The antibiotic was the only possible cause in the 12 cases of liver failure and all occurred in people with good health.

In addition to the four deaths:

• One patient had a liver transplant.
• Three were considered for a transplant.
• 23 had serious liver injury.
• 44 had non-serious liver events.

The estimated rate of reported liver failures connected to Ketek is 23 per 10 million prescriptions, far higher than any other antibiotic on the market. The FDA panel recommends that Ketek carry a black box label, which is the most serious.