FDA: Ketek Associated with Liver Injuries

WASHINGTON, D.C. - The FDA is notifying healthcare professionals and patients that Sanofi Aventis' Ketek antibiotic has been associated with rare cases of livery injury and failure.

On July 5, the FDA said it recently completed a safety of assessment of Ketek (telithromycin), finding that it has been linked to rare cases of serious livery injury and liver failure with four reported deaths, as well as one liver transplant after the administration of the medication. The agency said it is requiring additional warnings and that Sanofi Aventis is revising the label to address this safety concern.

Ketek is indicated for …