FDA Requires Liver Risk Warning On Alli, Xenical

Law360, New York (May 26, 2010, 6:42 PM EDT) -- The U.S. Food and Drug Administration plans to require diet drugs Xenical and Alli to carry new warnings about the risk of liver injury that has been associated with the medications in rare instances.

Citing 13 reports of serious liver injury in people taking the drugs, the FDA said Wednesday that it had already signed off on a revised label for Xenical, a prescription version of the orlistat drug manufactured by Roche Holding AG. The regulator is still working with Alli manufacturer GlaxoSmithKline PLC to revise...
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