August 25, 2009

FDA reviews Xenical, Alli safety issue

The U.S. Food and Drug Administration says it is reviewing reports of liver injury in patients taking the weight loss drug orlistat.

From 1999 to 2008, the FDA received 32 reports of serious liver injury in patients taking orlistat, which is marketed as the prescription drug Xenical and the over-the-counter medication Alli.

Of those cases, 27 reported hospitalization and six resulted in liver failure, the federal agency said. Thirty of the adverse events occurred outside the United States. The most commonly reported adverse events included yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain.

But the FDA cautioned no definite association between liver injury and orlistat has yet been established and consumers taking Xenical should continue to take it as prescribed. Those using over-the-counter Alli should also continue to use the product as directed, officials said.

Orlistat is marketed under the Xenical name by Hoffmann La Roche Ltd. Ali is marketed by GlaxoSmithKline.