08/24/2010 - News
FDA Warns of Liver Injury with Orlistat
By: June Chen, MD
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The U.S. Food and Drug Administration (FDA) has revised the label for orlistat (marketed as Xenical and Alli), a weight loss drug, in order to include new safety information about the rare possibility of severe liver injury associated with use of orlistat. While the FDA has already approved a revised label for Xenical, it is still working with the manufacturer of Alli on label revisions.
The FDA is advising healthcare professionals and consumers about rare cases of severe liver injury that have been reported with the use of orlistat. So far, the FDA has identified 13 cases of severe liver injury, all except one of which occurred outside of the United States. The only U.S. report of severe liver injury was related to Alli, which contains 60 mg of orlistat per pill. At the current time, a definite cause and effect relationship between orlistat and liver injury has not been established, but people who take either Xenical or Alli should be aware of the potential risk.
Worldwide, an estimated 40 million people have taken orlistat, whether it was prescription Xenical or over-the-counter Alli. Those taking orlistat should be aware of the signs and symptoms of liver injury, including itching, yellowing of the eyes or skin, dark urine, loss of appetite, or clay-colored stools. If orlistat users experience any of these signs and symptoms, they should notify their healthcare professional.
Source: U.S. Food and Drug Administration Press Announcement, 26 May 2010.
Created on: 05/31/2010
Reviewed on: 08/24/2010
Reviewed on: 08/24/2010
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