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Alli, Xenical Face European Safety Review

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Four suspected cases of “serious liver toxicity” are prompting the European Medicines Agency to conduct a safety review of the popular weight loss medications Alli and Xenical.

Orlistat is the active ingredient in both Xenical and Alli. Xenical, sold via prescription only, is manufactured by Roche and contains 120 milligrams of orlistat. The over-the-counter (OTC) Alli, marketed by GlaxoSmithKline, contains 60 mg. Xenical was approved by the U.S. Food and Drug Administration (FDA) in 1999 and Alli was approved in 2007.

Alli and Xenical work differently than other diet pills, by reducing the body’s ability to absorb fat. Traditional diet aids speed up metabolism or suppress the appetite.

The Telegraph said that the European Medicines Agency (EMA) will review existing evidence linking orlistat medications to liver damage and will determine if licenses for orlistat-containing medications require revocation or change. Orlistat is extremely popular in Europe, said The Telegraph, which noted that data reveals orlistat comprised about 74% of the 1.45 million weight-loss drugs prescribed in England in 2009. And, because two other diet aids—both of which alter how people think about food—have been suspended, Xenical has been the main choice prescribed by physicians.

The EMA said in a statement that it “has started a review of orlistat-containing anti-obesity medicines, to determine whether the very rare cases of hepatic injury have an impact on their benefit-risk profile and conditions of use,” reported The Telegraph. The EMA has received 21 reports of suspected liver damage linked to prescription versions of orlistat from August 2009 and January 2011. Four cases were severe. One led to a patient’s death and another patient needed a liver transplant, said The Telegraph.

The EMA continued, “The Committee is now reviewing all relevant data on the risk of hepatotoxicity of orlistat-containing medicines and will issue an opinion on whether or not the marketing authorisations for these medicines should be revoked, suspended or changed.”

In the U.S., public advocacy group, Public Citizen, has been urging the FDA to ban Xenical and Alli over adverse reactions to the liver, pancreas, and kidney, saying that the drugs’ benefits are outweighed by its riss. In the U.S., safety labels for Xenical and Alli were updated last year to include information about potential rare cases of severe liver injury in patients, according to the FDA.

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