FDA Restricts Indications, Revises Label for Antibiotic Ketek

WASHINGTON, D.C. - The FDA recently withdrew two of the three previously approved indications for Sanofi Aventis' Ketek (telithromycin) antibiotic, saying that the balance of benefits and risks no longer supports approval of the drug for treating acute bacterial sinusitis or chronic bronchitis.

The agency's Feb. 12 announcement further stated that although Ketek will remain on the market for the treatment of community-acquired pneumonia of mild to moderate severity, the drug will also carry stronger warnings about possible side effects such as vision problems and loss of consciousness.

In addition, a 'black box' warning now states that Ketek should not …