Ketek prescribing information is revised

France's Sanofi-Aventis says that, following a discussion with the US Food and Drug Administration, it has revised the prescribing information for its antibiotic Ketek (telithromycin). The revision details that some cases of acute hepatic failure have been observed in those treated with the drug.

Earlier this month, Sanofi announced that it had halted enrollment in trials of the drug in children as a precautionary measure, but stressed that the action had not been requested by the FDA (Marketletter June 19).

The firm said that the prescribing information update is based on an in-depth review of all safety data, and restated its belief that, having studied preclinical, clinical and post-marketing data, the product's benefits outweigh its risks.