Liver Damage Warning Label Put on Ketek

June 2006

Ketek, an antibiotic currently the focus of a congressional investigation for safety issues, is getting a new warning label. The drug’s manufacturer, Sanofi-Aventis added a new warning label noting the risk of liver failure and injury. The label will now have bold text warning that “acute hepatic failure and sever liver injury, in come cases fatal, have been reported in patients treated with Ketek.”

The warning isn’t as strong as a Food & Drug Administration (FDA) mandated “black-box” warning but does emphasize the severity of possible complications. The agency still feels Ketek’s benefits outweigh the risks.

Although other antibiotics also cause liver failure, Ketek does so almost four times as often, concluded a review by safety officials. Fourteen adults taking Ketek in the US have suffered liver failure. Four of them have died and another 23 sustained serious liver damage. In addition, the FDA recently received two more reports of potential liver failures in people who took Ketek.