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Alli, Xenical Get Warnings For Severe Liver Injury

May 27, 2010 | Parker Waichman LLP The safety labels for Xenical, and its over-the-counter counterpart, Alli, are being modified to include information about potential rare occurrences of severe liver injury in patients, the U.S. Food & Drug Administration (FDA) announced yesterday. The popular weight loss medications have been used by an estimated 40 million people worldwide.

Both Xenical and Alli contain the same active ingredient, orlistat. Prescription Xenical contains 120 milligrams of orlistat. Alli, sold over-the-counter without a prescription, contains 60 mg of orlistat. The FDA first approved Xenical in 1999, and Alli was approved in 2007.

The FDA began a safety review of orlistat in 2009, following reports of 32 cases of serious liver injury, including six cases of liver failure between 1999 and October 2008. Two of those cases occurred in the United States. For 27 patients, the symptoms were severe enough to require hospitalization.

According to the FDA, its completed review ultimately identified 13 total reports of severe liver injury with orlistat. Twelve reports originated overseas with Xenical. There was one U.S. report involving Alli. Of the 13 cases, two patients died and three required liver transplantation.

At this time, a cause and effect relationship of severe liver injury with orlistat use has not been established, the agency said.

Because of the seriousness of severe liver injury, the FDA said it has added information about reported cases of severe liver injury to the label of Xenical and Alli to educate the public about the signs and symptoms of liver injury and the need to see a physician promptly should they occur. The agency said it has already approved a revised label for Xenical, and is working with the manufacturer of Alli on label revisions to reflect this risk.

Patients who are taking either Alli or Xenical should contact their healthcare professional if they develop symptoms of liver injury, including itching, yellow eyes or skin, dark urine, loss of appetite, or light-colored stools.

The FDA has advised healthcare professionals to weigh the benefits of weight-loss with the potential risks associated with Xenical and Alli before prescribing or recommending these medications to their patients.

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