Europeans Looking Again at Orlistat and Liver Injury

September 23, 2011

September 22, 2011 (London, United Kingdom) The European Medicines Agency (EMA) says that it has started a review of orlistat-containing medicines to determine whether the "very rare cases of hepatic injury have an impact on their benefit-risk profile and conditions of use" [1].

The review affects the prescription-only product Xenical (orlistat 120 mg, Roche) and the over-the-counter-medicine Alli (orlistat 60 mg, GlaxoSmithKline), both of which were approved through the centralized European process, as well as a number of products containing orlistat that have been authorized at a national level in various European countries.

The EMA says the risk of liver reactions with orlistat is well-known and is reflected in the product information for centrally authorized orlistat-containing products. It adds that "the vast majority of reports of liver injury are not serious, and severe liver injury has been reported only very rarely" and that the new review focuses on the strength of evidence relating to severe liver injury.

It reports that the most recent analysis identified 21 suspected cases of hepatic injury with orlistat 120 mg between August 2009 and January 2011, of which four were severe. The severe cases included 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.

The agency adds that 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, although alternative explanations for liver injury are present in many of the cases. It says that the number of cases needs to be considered in the context of cumulative usage of these medicines in 38 million patients.

For the 60-mg orlistat product, there have been a total of nine reports of suspected severe liver injury between May 2007 and January 2011, with a cumulative usage of the product in an estimated 11 million patients. Again, the agency points out that in some of these cases other possible explanations for liver injury were present.

The EMA says it 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 should be revoked, suspended, or changed.

Last year the US FDA issued a warning about the risks of severe liver injury with orlistat use, based on 13 reports of liver toxicity, in which two patients died of liver failure and three required liver transplants. However, the US drug-safety watchdog Public Citizen wants more drastic action and has been campaigning to have orlistat products removed from the market, citing new data obtained from FDA adverse-reaction files, including 47 cases of acute pancreatitis and 73 cases of kidney stones.

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