The consumer advocacy group Public Citizen is urging the FDA to immediately pull two weight loss drugs, Xenical and Alli, from the market. The group says the drugs' risk for liver, pancreas, and kidney damage greatly outweighs any potential weight loss benefits.



Xenical and Alli are different strengths of the drug orlistat. Prescription-strength Xenical is manufactured by Roche. Alli is available over the counter, and is one-half the strength of Xenical. These drugs block the absorption of fat in the gastrointestinal tract. Alli manufacturer GlaxoSmithKline announced plans to sell the rights to the over-the-counter drug Alli.



In May 2010, the FDA issued a warning based on post-marketing adverse events about risk of severe liver injury in people taking orlistat, citing 12 foreign reports of liver toxicity with Xenical and one case of liver toxicity in the U.S. associated with the use of Alli. Two of these patients died, and three needed liver transplants as a result of this damage.



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