FDA pulls Ketek from AECB and ABS market

French drug major Sanofi-Aventis says that a US Food and Drug Administration Joint Advisory Committee has recognized the positive benefit-risk profile and recommended continued marketing of Ketek (telithromycin) in mild-to-moderate community acquired pneumonia, but recommended against continued marketing in acute exacerbation of chronic bronchitis and acute bacterial sinusitis.

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 had been observed in those taking the first-in-class ketolide antibiotic (Marketletter July 10, 2006).