The FDA announced that the antibiotic Ketek, used to treat pneumonia, must come with a new “black box label” — the strongest warning the agency can impose on a drug. Additionally, Ketek can no longer be recommended for treating milder conditions such as sinusitis and bronchitis. The changes come after the medication was found to cause serious liver damage in studies.
The drug and the related approval process have been dogged by criticism … Last June, Sanofi-Aventis agreed to update Ketek’s labeling to reflect the possibility of severe liver damage. And last month, a European Medicines Agency panel recommended that Ketek not be given to patients with a history of such liver conditions as hepatitis or jaundice.
Sanofi-Aventis is currently under investigation by both the U.S. House and Senate for irregularities during the approval process.