US FDA restricts use of Sanofi-Aventis' Ketek

The US Food and Drug Administration has narrowed the approved indications for the controversial antibiotic Ketek (telithromycin), recommending that it should only be used to treat pneumonia and not more life-threatening conditions.

French drug major Sanofi-Aventis' first-in-class ketolide antibiotic has been linked to liver problems and last month, the FDA withdrew the agent from the acute exacerbation of chronic bronchitis and acute bacterial sinusitis markets on the recommendation of Joint Advisory Committee (Marketletter January 1 & 8).

Last year, an investigation was started after reports of liver toxicity in patients using the drug (Marketletter November 20, 2006). A few months before, the US drug regulator revised Ketek's label, warning that rare cases of acute hepatic failure has been reported in patients using the agent (Marketletter July 10, 2006).