The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has finalised its review into orlistat-containing medicines and the possible risk of severe liver injuries. The 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.

Following a review of the available data, the CHMP considered that there was no strong evidence that orlistat increased the risk of severe liver injury, and there was no known mechanism by which orlistat was expected to cause liver disorders. The Committee concluded that the number of reported severe liver reactions in orlistat users was low and below the background rate expected in these people, given the large number of users. A pattern was not seen in the type of liver problems reported, and in most cases there were other factors which were likely to increase the risk of liver injury, such as existing health problems or the use of other medicines. The Committee considered that while there may be very rare cases of serious liver injury for which causality with orlistat cannot be excluded, the cases do not provide good evidence of a causal association. The CHMP also noted that published population-based studies suggest that obesity may be associated with a higher risk of liver disease.

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.

Please see links below for further details, including the background on why the review was initiated.