FDA adds warning labels to popular GSK weight-loss drugs

Federal health officials are warning consumers that weight loss pills made by GlaxoSmithKline may cause severe liver damage in rare cases. The FDA added a warning label Wednesday to packages of alli and Xenical.

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RESEARCH TRIANGLE PARK, N.C. — Federal health officials are warning consumers that the weight loss pills alli and Xenical may cause severe liver damage in rare cases.

The Food and Drug Administration said Wednesday it has added a warning about the risk to the label of the drug, which is sold over-the-counter by GlaxoSmithKline (NYSE: GSK). A prescription version called Xenical is manufactured by Roche and sold by GSK.

GSK’s U.S. headquarters are located in Research Triangle Park, N.C.

The company is making information available about the drug at 1-800-671-2554 or a Web site (

The FDA identified 13 instances of liver damage associated with the drugs. A causal effect between the drugs and the problem has not been established.

The FDA urged doctors and patients to watch for signs of liver injury, including itching, yellow eyes and skin and loss of appetite.

GSK said in a statement it is "committed to ensuring that consumers and physicians understand the safety profile" of alli.

“GSK is committed to ensuring that consumers and physicians understand the safety profile of orlistat and alli," said Howard Marsh, chief medical officer for GSK Consumer Healthcare.

"Although reports of serious liver injury in people taking orlistat are rare, GSK takes all adverse events reports seriously. Reaching and maintaining a healthier weight is one of the most important things people can do for their health. GSK wants people to have the information they need to choose the right weight loss aid for their situation,” he added.

More than 10 million people worldwide have used alli since it was launched, according to the company.

Roche said the "safety profile of Xenical is based on more than 10 years of clinical experience and more than 36 million patients worldwide have received Xenical."

The FDA first approved Xenical in 1999 and alli in 2007.

U.S. sales of alli more than doubled last year to $293 million, though they have come nowhere near the blockbuster numbers originally expected by Wall Street after the drug's 2007 launch. Analysts say the brand has been hurt by lower consumer spending as well as unpleasant side effects, such as anal leakage.

GlaxoSmithKline, based in London, is one of the world's largest drug companies.

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