EMA Confirms Positive Benefit-risk Balance of Orlistat-containing Medicines

Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of orlistat-containing medicines continue to outweigh their risks.

Finalising its review on orlistat-containing medicines and the possible risk of severe liver injuries, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefit of these medicines continue to outweigh their risks in the treatment of obese or overweight patients with a body mass index of 28 kg/m2 or above.

The Committee recommended that the product information for these products should be harmonised to ensure that the information on possible very rare liver-related side effects is the same for all orlistat-containing medicines.

This review included the centrally authorised medicines Xenical and Alli (available ‘over the counter’ at a lower dose) and nationally authorised orlistat-containing generics.