The ongoing debate over the safety of Sanofi-Aventis’ antibiotic Ketek, has prompted the US Food and Drug Administration to schedule an external advisory committee meeting next month to explore the drug’s link to liver failure.
Ketek (telithromycin) has been a thorn in the side of the FDA, with a Senate Finance Committee investigating the agency’s handling of its review and approval amid allegations that it glossed over evidence of fraud and misconduct in a key clinical study for the antibiotic. Ketek has been linked to a number of cases of serious liver injury and liver failure.
The Anti-infective Drugs Advisory Committee will meet on December 14 and 15 to “discuss the overall benefit to risk considerations” for Ketek, according to the FDA’s website.
Ketek was approved in 2004 and is indicated for treating acute bacterial exacerbations of chronic bronchitis, acute bacterial sinusitis, and community acquired pneumonia. Earlier this year both the FDA and European Medicines Agency (EMEA) tightened up the product’s labelling to warn of liver side effects.
In June, Sanofi halted trials of Ketek in children, although insisted the safety concerns were not behind the move.
Sanofi has not reported Ketek sales since the third quarter of 2005, when it posted a 7.3% decline in turnover to 38 million euros ($47m) year-on-year, and the antibiotic is a minor product for the company despite once-touted as a potential blockbuster.