EMA turns positive on orlistat and aprotinin; CHMP backs Pixuvri

Finalizing 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 28kg/m2 or above.

The Committee recommended that the product information for these products should be harmonized 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 authorized medicines Roche’s Xenical and Alli (which had been available over the counter at a lower dose from GlaxoSmithKline, which is trying to dispose of the brand) and nationally authorized orlistat-containing generics.

The risk of very rare liver-related side effects in association with orlistat has been under close review by the CHMP since 2001 for Xenical, when the product information was updated to reflect post-marketing reports of liver reactions in association with orlistat. The current product information for orlistat-containing medicines lists hepatitis, cholelithiasis and a change in liver enzyme levels as potential liver-related side effects.