Ketek Subjected to New FDA Scrutiny

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November 15th, 2006

"Ketek Under New Scrutiny"

A popular antibiotic that has been linked to rare cases of severe live damage including several deaths faces more scrutiny by the U.S. Food and Drug Administration as a panel of outside medical experts will thoroughly evaluate the risks and benefits of Ketek.

This announcement comes hand in hand with an investigation of fraud allegations connected with Ketek clinical trials, as well how officials at the FDA handled safety problems linked to the drug.

The panel review of Sanofi-Aventis SA''s Ketek could result in stronger label warnings and other actions to ensure the safety of millions of patients who use the antibiotic.

Ketek Dangers

In April 2006, the FDA received more than a dozen reports of severe liver failure, in addition to four deaths, in patients treated with Ketek. The agency is also aware of nearly two dozen cases in which people suffered serious injuries of the liver after taking the drug.

According to FDA documents, the rate of injuries with the use of Ketek seemed higher compared with similar antibiotics.

Currently, Ketek carries a bold warning about the possible risks of acute liver failure, serious injury, and even death among patients taking the antibiotic.

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