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Reports of Hepatotoxicity for Orlistat, the Active Ingredient for Xenical and Alli

On April 16, 2009, the Drug Safety Oversight Board briefly discussed orlistat and the potential risk of hepatotoxicity.

Orlistat is the active ingredient in anti-obesity drugs such as the prescription drug Xenical and the over-the-counter drug Alli.

Xenical is manufactured by Roche, which is headquartered in Nutley, N.J. Alli is manufactured GlaxoSmithKline, which is headquartered in England.

Sue Sutter of Scrip News in her May 21, 2009 article “US FDA examining reports of liver damage with orlistat” gives more details on the relationship between Orlistat and hepatotoxicity.

“Orlistat was discussed in the context of both non-prescription and prescription versions and the potential risk of hepatotoxicity based on several post marketing reports,” the FDA told Scrip.

The agency said it was still reviewing the case reports to determine the extent of orlistat’s contribution, if any, to the development of liver damage. The FDA declined to provide the number of post marketing reports it has received and said any action would depend upon results of its ongoing analysis….

Roche said more than 35 million patients have been exposed to orlistat therapy, and obesity is a high risk factor for hepatic injury. “The available information – post marketing spontaneous reports, clinical trial data and published literature as well as epidemiology data for drug-induced liver disease – does not suggest that orlistat is causally related to hepatic events.”

Currently in Xenical’s package insert there are only rare reports of hepatic, or liver, injury.

The FDA has investigated Orlistat over concerns of rectal bleeding. See: Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April – June 2008

Any adverse reactions, such as hepatitis, liver injury or liver failure experienced with the use of Xenical or Alli should be reported to the FDA’s MedWatch Program

by phone at 1-800-FDA-1088,
by fax at 1-800-FDA-0178,
by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787,
or on the MedWatch website at

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