The FDA reports that the antibiotic Ketek may be linked to twelve cases of liver failure (including four deaths). The FDA recommends that Sanofi-Aventis adds a warning label to the drug's packaging.
Ketek was approved by the FDA in 2004 for the treatment of acute bacterial infections from chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia.
The FDA conclusion relates to a May 16, 2006 memorandum the FDA's Division of Drug Risk Evaluation. There had been information posted by the FDA in January of 2006 which you can read here.
To the shock of no one, the company has stated in a release that it continues to believe that Ketek is safe and effective when used as directed.
Sources include the WSJ print edition, AP, and Yahoo.