Tuesday, November 14, 2006

WSJ: Sanofi-Aventis Antibiotic Under FDA Scrutiny

Article in the Wall Street Journal -- Sanofi-Aventis Antibiotic Faces New FDA Scrutiny, by the Associated Press:

An antibiotic from Sanofi-Aventis SA that has been linked to rare reports of severe liver problems -- including several deaths -- will be subjected to new scrutiny by federal health advisers, according to a document released Tuesday.

The Food and Drug Administration has asked a joint panel of outside experts to discuss the overall risks and benefits of the French drug maker's Ketek antibiotic during a Dec. 14-15 meeting, according to a federal notice.

The announcement comes as the Senate Finance Committee investigates allegations of fraud connected with trials of Ketek, as well as how the FDA has handled safety issues associated with the drug. The joint panel's two-day review of Ketek could lead to a recommendation that the agency add further warnings to the drug's label or take other action.

Here's a link to the New York Times article, FDA Subjects Antibiotic to New Scrutiny, by the Associated Press.



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