Tuesday, June 01, 2010

Diet Drug Alli Linked to Severe Liver Damage

The FDA has started an investigation into whether the diet drug orlistat, marketed as both Alli and Xenical, has been causing serious liver damage in some patients.

Prescription-strength Xenical was approved by the FDA in 1999. Half-strength Alli was approved as the first (and to date, only) over-the-counter weight loss drug in 2007.

Since 1999, there have been 32 adverse event reports linking orlistat to severe liver damage. Twenty-seven patients have been hospitalized for liver problems, and six suffered from outright liver failure. Both of the cases involving Alli took place within the United States, while the other 30 cases, involving Xenical, all took place in other countries.

The FDA discussed its concerns with orlistat at an April meeting of the agency's Center for Drug Evaluation and Research Drug Safety Oversight Board, then eventually decided to further investigate the issue. It is also reviewing data on other potential cases of liver damage submitted by GlaxoSmithKline, which markets Alli, and Roche, which markets Xenical. Read more...

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