Antibiotic Linked to Severe Liver Damage, Says FDA

By Elizabeth Rhein

Published on June 30, 2006

Since its approval in 2004, Ketek has been reported as causing at least 12 cases of liver failure. Four of those cases resulted in death. An additional 23 cases of less severe liver damage have also been reported.

Ketek, also known by the generic name telithromycin, is often prescribed by doctors to patients whose illnesses are caused by bacteria that does not respond to more traditional antibiotics. Common illnesses requiring Ketek include bronchitis, sinusitis, respiratory tract infections, and some kinds of pneumonia.

The obvious benefits of such a drug have kept Ketek on the market thus far. Both the FDA and the drug's maker, Sanofi-Aventis, believe that the benefits outweigh the risk of liver damage.

The FDA has responded to recent Senate inquiries by changing the labeling required for Ketek to a bold-type warning.

The updated warning cautions patients and doctors to be aware of the symptoms of hepatitis that would signal the onset of liver damage. The warning also alerts users to the risk of acute respiratory failure when used by patients with certain autoimmune disorders.

If you or a family member have taken Ketek and are concerned about the possible side effects, talk to your doctor to determine the best course of action.

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