Ketek antibiotic drug faces intense FDA scrutiny over liver failure reports
Thursday, November 16, 2006 by: Jerome Doulgas
 Printable version   Key concepts: Ketek, the FDA and Sanofi-Aventis.

http://www.newstarget.com/021095.html

(NewsTarget) With reports of liver failure in a dozen patients and four associated deaths becoming public knowledge, U.S. health officials said this week that they plan to ask outside advisors if Ketek -- an antibiotic made by Sanofi-Aventis -- should continue to be allowed on the market.

In 2004, Ketek was approved by the FDA but has become a subject of a U.S. Senate Finance Committee investigation into whether the FDA's handling of Ketek's approval and possible use of faulty data was in error. FDA spokeswoman Laura Alvey said, "We will ask the committee if the overall risk/benefit profile supports continued marketing of Ketek for various indications."

A public meeting of outside officials who are experts on anti-infective drugs will be convened by the FDA in order to have Ketek discussed.

Alvey added that "a comprehensive analysis of all safety data for Ketek" will be considered. Ketek is approved to treat acute bacterial worsening of chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia.

Sanofi spokeswoman Lisa Kennedy said that the drug's parent company -- Sanofi-Aventis -- looked forward to discussing the data at the meeting. Kennedy had no comment on what action could be taken as a result of the meeting's outcome.

Kennedy added that "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." Sales of Ketek for the first half of 2006 are estimated at $50 million according to data released this June by Sanofi-Aventis.
That same June, the FDA received reports of acute liver failure in Ketek patients, which included four deaths. A new warning on the drug's packaging and marketing was added in June as well.

Senate Finance Committee Chairman Charles Grassley, R-Iowa, stated "It's good to see the FDA doing due diligence with Ketek. The agency needs to do everything possible to make sure material information is not withheld from the advisory committee during this meeting," when asked about the upcoming outside panel meeting being organized by the FDA.