Friday, December 15, 2006

Ketek -- FDA Advisory Committee Gets it Right

It's all about weighing risk vs benefit. . .
A U.S. Food and Drug Administration advisory committee recommended late Friday that a "black-box" warning be added to the controversial antibiotic Ketek for its use in fighting pneumonia. It's also possible that the drug will lose its approval for two lesser indications, sinusitis and bronchitis.

. . . At the end of the second day, the committees voted 16-to-3 that the benefits of Ketek (telithromycin) outweighed the risks for community-acquired pneumonia, a potentially life-threatening condition. >Full Story: HealthDay News
The FDA will now consider carefully the advisory committee's advice before taking any regulatory action.

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