Following an orlistat safety review, on May 26 2010 the US Food and Drug Administration (FDA) announced that it has approved an upgrade to the diet pill’s label to include new information about the risk for severe liver damage that has been reported with orlistat’s use. The FDA reviewed risk of liver side effects for both prescription Xenical (orlistat 120mg) and over-the-counter (OTC) Alli (orlistat 60mg).
FDA Safety Review for Risk of Liver Side Effects of Orlistat (OTC Alli, Xenical)In August 2009, the FDA announced via an 'Early Communication' notice that the regulatory authority was undertaking a safety review of orlistat-containing products, due to a number of possible liver-related side effects that had been reported for the weight loss drug since its availability in 1999.
At the time, the FDA notified the public that from 1999 to October 2008, the regulatory body had received 32 reports of serious liver injury in people taking orlistat, which included six cases of liver failure. The most commonly reported liver-related adverse events were jaundice, weakness, and abdominal pain, with hospitalization required for 27 of the 32 cases.
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