FDA will examine safety of Sanofi antibiotic

The FDA has asked a panel of outside experts to discuss the overall risks and benefits of the antibiotic Ketek during a meeting in December, according to a federal notice released Tuesday.

“We will ask the committee if the overall risk/benefit profile supports continued marketing of Ketek for various indications,” an FDA spokeswoman, Laura Alvey, said.

Earlier in the year, the FDA said it had received 12 reports of acute liver failure in Ketek patients which included four deaths. Ketek was also rejected twice before gaining approval in the US.

“Based on the data available to us and after consultation with experts, we continue to believe the benefits of Ketek outweigh the risks when the drug is used as directed in its approved indication,” commented a Sanofi representative Lisa Kennedy.

Ketek is indicated for mild to moderate respiratory tract infections including acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis and community-acquired pneumonia.