FDA Panel Calls for New Restrictions on Sale of Controversial Antibiotic

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December 15, 2006 6:20 PM

An FDA advisory panel now recommends that the controversial antibiotic Ketek no longer be sold to treat certain health conditions.  The decision follows two days of deliberations over the safety of Ketek.   

Ketek, an antibiotic used to treat respiratory infections, has been beset by controversy for months following reports of dozens of liver injuries and four deaths among users of the drug.   

In addition, the results of an FDA-commissioned safety trial on Ketek were called into question after the director of the largest trial site was convicted of falsifying patient information. 

Despite these concerns, the FDA approved Ketek in 2004, based largely on patient data from Europe and Latin America.   

The FDA panel recommends that the manufacturer, Sanofi-Aventis, not be allowed to continue to market Ketek for the treatment of "acute bacterial worsening of bronchitis or acute bacterial sinusitis."  The panel had earlier supported the continued sales of Ketek to treat "pneumonia acquired outside a hospital."

Sanofi-Aventis has said the benefits of Ketek outweigh the potential risks.  The FDA has said it approved Ketek after a rigorous review by top doctors, scientists and statisticians.