Last week the U.S. Food and Drug Administration (FDA) announced the approval of revised labeling for the prescription weight-loss drug Xenical (orlistat 120 mg) and its OTC version Alli (orlistat 60 mg).
The revised label carries new safety information regarding cases of severe liver injury that have been reported with the use of orlistat. It is important to note that these cases have occurred only rarely, estimated at 13 cases out of the approximate 40 million people worldwide who have used this medication since its approval in 1999 (Xenical) and 2007 (Alli).
Of the 13 cases of severe livery injury, 12 were foreign reports associated with the use of Xenical and one was a U.S. report associated with Alli use. Two patients died from liver failure and three patients required liver transplants. A causal relationship has not been established as other factors or drugs may have contributed to the development of severe liver injury.
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Weight Loss Drugs, Xenical and Alli, Receive New FDA Warning Label