EMA Starts Review of Orlistat-containing Medicines

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

The European Medicines Agency is reviewing 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.

The review includes the centrally authorised prescription-only medicine Xenical (orlistat 120 mg) and the centrally authorised over-the-counter-medicine Alli (orlistat 60 mg), as well as a number of medicines containing orlistat that have either already or are in the process of being authorised at national level.

The risk of liver reactions with orlistat is well known and had been kept under close review by the Agency’s Committee for Medicinal Products for Human Use (CHMP) since the initial marketing authorisation of these medicines. The risks of liver reactions is