FDA Requires Liver-Injury Warning On 2 Weight-Loss Drugs

MAY 26, 2010

WASHINGTON (Dow Jones)--The U.S. Food and Drug Administration said Wednesday it is requiring a new warning about liver injury to be placed on the weight-loss drugs Xenical and Alli.

Xenical is a prescription weight-loss drug made by Roche Holding AG (RHHBY, ROG.VX) while Alli is an over-the-counter version of the same drug marketed by GlaxoSmithKline PLC (GSK, GSK.LN) at a lower dose.

The FDA said the warning is based on rare reports of liver injury associated with the products. From April 1999 to August 2009 the agency said it received 12 reports of liver injury associated with Xenical from outside the U.S. and one U.S. report associated with Alli. Among those reports, two people died and three people needed a liver transplant.

The FDA said an estimated 40 million people worldwide have used Xenical or Alli.

Both Roche and GlaxoSmithKline noted that the reports of liver injury were rare.

Roche said the company would continue to monitor Xenical's safety profile and share that information with health regulators.

GlaxoSmithKline said the updated Alli label will advise consumers to "stop use and ask a doctor" if they "develop itching, yellow eyes or skin, dark urine or loss of appetite. There have been rare reports of liver injury in people taking orlistat." Orlistat is the active ingredient in Xenical and Alli.

The FDA said some patients with severe liver-injury cases also used other drugs or had other conditions that may have contributed to the development of their liver problems.

"At this time, a cause-and-effect relationship of severe liver injury with [Xenical or Alli] use has not been established," the agency said in a statement.

The FDA, however, said that because of the seriousness of such injury it was adding the information to labels of Xenical and Alli to educate the public about its signs and symptoms.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com