November 15, 2006
Panel to review Sanofi-Aventis’ Ketek
The FDA will convene a joint panel of outside experts to examine the risks and benefits of Sanofi-Aventis’ antibiotic Ketek (telithromycin).
The panel will meet from Dec. 14-15 to discuss the drug. The results of the two-day review of Ketek could lead to further warnings on the drug’s labeling or other action.
Notice of the review comes as the Senate Finance Committee investigates allegations of fraud in connection with clinical trials of Ketek, as well as how federal regulators have handled safety issues associated with the drug.
The FDA has received about a dozen reports of acute liver failure, including four deaths, among patients using Ketek. The agency has also received 23 reports of liver injuries in patients who took Ketek.
In July Sanofi-Aventis updated prescribing information for Ketek following an FDA safety assessment advising doctors and patients to be aware of rare but serious health risks associated with use of the drug.
The revised prescribing information contained a bolded warning and additional information telling patients to discontinue Ketek use if hepatitis-like symptoms develop. The labeling also recommended that Ketek only be used by patients with myasthenia gravis, a neuromuscular disorder, if no other treatment option is available. Ketek is often prescribed to treat upper respiratory tract diseases such as bronchitis.
A Sanofi-Aventis spokeswoman told the Wall Street Journal the drugmaker welcomes the opportunity to discuss Ketek.
“Based on the data available to us, and in consultation with leading experts, we continue to believe the benefits of Ketek outweigh its risk when the drug is used as directed for its approved indications,” the spokeswoman said.