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Popular anti-obesity drug under review in Europe regarding severe liver toxicity
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Orlistat-containing anti-obesity drugs are under review by the European Medicines Agency after an analysis found four cases of severe liver toxicity with suspected links to the drug.
The review includes the prescription-only Xenical (orlistat 120 mg, Roche) and the over-the-counter Alli (orlistat 60 mg, GlaxoSmithKline), as well as other medicines that contain orlistat.
Approximately 38 million patients in Europe take medications with orlistat, according to the agency. The drug decreases the absorption of fat, which reduces the number of calories a person absorbs.
The majority of reports of liver injury are not serious, and severe liver injury has been reported rarely. The agency’s new review focuses on the strength of evidence relating to severe liver injury.
The most recently submitted analysis, which covers cases of hepatic events reported with 120 mg of orlistat from August 2009 to January 2011, identified 21 suspected cases, of which four involved severe liver toxicity. There was 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.
From 1997 to January 2011, there were 21 cases of suspected serious liver toxicity for which a causal link to orlistat cannot be ruled out, although these cases “do not provide strong evidence of a link to orlistat as alternative explanations for liver injury are present in many of the cases,” according to the agency.