Alli, Xenical Liver Injuries Prompt European Review

Alli and <"">Xenical, weight loss drugs made with the active ingredient orlistat, are being reviewed by European regulators following some rare cases of severe liver injury. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has started a review to determine whether the liver injury cases have an impact on the drug’s benefit-risk profile and conditions of use.

<"">Alli, which contains a 60 mg dose of orlistat, is an over-the-counter medication made by GlaxoSmithKline. Xenical, available by prescription only and sold by Roche, contains 120 mg of orlistat. According to the EMA statement, 38 million people have used Alli, and 11 million have used Xenical.

Liver problems are an acknowledged side effect of orlistat, and in May 2010, the U.S. Food & Drug Administration (FDA) ordered that the labels of Alli and Xenical be modified to include information about potential rare occurrences of severe liver injury in patients. This past April, the consumer group, Public Citizen, asked the FDA to ban both Xenical and Alli over risks to the liver, pancreas, and kidney.

According to the EMA statement, between August 8, 2009 January 23, 2011, it identified a total of 21 suspected cases of hepatitic events associated with 120 mg orlistat (Xenical). Of these, 4 were cases of severe liver toxicity (one fatal case of hepatic failure, one case of hepatic failure leading to liver transplantation, one case of exacerbation of hepatitis and one case of hepatitis). Overall, between 1997 until January 2011, there were 21 cases of suspected serious liver toxicity for which a causal link to orlistat cannot be excluded, the EMA said.

The EMA also found 9 reports of suspected severe liver injury with orlistat 60 mg (Alli), although in some cases other possible explanations for liver injury were present and some cases provided insufficient information to allow assessment.

The EMA said all of the cases need to be considered in the context of cumulative usage of these medicines among tens of millions of patients.

CHMP 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 authorizations for these medicines should be revoked, suspended or changed, the statement said.

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