US to ask if Sanofi antibiotic Ketek should still be soldU.S. health officials said they plan to ask outside advisers in December 2006 if the antibiotic Ketek manufactured by Sanofi-Aventis should stay on the market after a dozen reports of liver failure.
The antibiotic which was approved in 2004 is also the subject of a U.S. Senate Finance Committee investigation of the FDA's handling of the approval and of possibly faulty data.
The independent advisory will determine the overall risk/benefit profile of continued Ketek marketing. Ketek, whose chemical name is telithromycin, had U.S. sales for the first half of 2006 estimated at $50 million.
Concern over Ketek was ignited earlier this year when researchers began reporting cases of liver failure and death in patients who took the drug. Ketek was rejected twice due to a lack of safety data before gaining FDA approval.
In June, the FDA said it had received 12 reports of acute liver failure in Ketek patients, including four deaths. That same month, the company added a new warning on the drug.
