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FDA adds warning labels to popular GSK weight-loss drugs

Posted May 26, 2010

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— 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 (www.myalli.com).

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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  • JustOneGodLessThanU May 27, 2010

    27615, they didn’t recall anything. 13 people, out 10 million!, MAY have had a reaction to the drug (they're not really sure), so the FDA added a "warning" to the label. Reasonable precaution, right?

    Meanwhile, the Tea Party folks want to do away with the FDA completely...and let it be every man for himself! Then, we wouldn’t have to worry about these pesky warning labels at all! ;-)

  • spacecowgirl73 May 27, 2010

    Beachboater: OMG you crack me up! that was funny. BTW I had a patient that took Alli to treat her chronic constipation. Anything that compromises fat absorption in the body can cause liver damage (example: statins for cholesterol).

  • kmichael May 27, 2010

    WHOA beachboater, you're killin us! Way too much info. Do you still wear those shoes?

  • beachboater May 27, 2010

    I think the TV ads say that you could experience something like an oily leakage and recommend that you should keep a change of clothes with you at all times.

    I actual took this stuff years ago as a prescription. I think I took it about a week. I had no problem with any type of "aXXXnal leakage". I did however expel just the tiniest bit gas one night, in the bathroom I might add, and the slight "aXXXnal leakage" I experienced, almost filled up my shoes.

    Needless to say, I didn't finish the bottle.

    Amazing how a word is acceptable in the body of the story, (the area from where the leakage could occur) but not acceptable in a GOLO post.

  • kmichael May 27, 2010

    Yeah, how about ending this article at "unpleasant side effects".

  • Gabby01 May 26, 2010

    Really WRAL, you had to put that last sentence in there ?

  • ncsingledad2boys May 26, 2010

    an-l leakage, um gross, yeah thats what i wanted to hear

  • 27615 May 26, 2010

    i love how drugs are approved and then recalled after millions of people have already taken them