Today, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has announced its decision to recommend that marketing authorisation be granted for the combination naltrexone + amfebutamone (also known as bupropion) for use in weight control (Mysimba in the EU/Contrave in other parts of the world), despite “uncertainties with regard to cardiovascular outcomes in the longer term”.

A major regression for European patients’ safety. Amfebutamone is an amphetamine drug, as is amfepramone. In 2000, the EMA withdrew the marketing authorisation of several appetite suppressants with a similar mechanism of action to that of amfepramone (clobenzorex, dexfenfluramine, fenfluramine, fenproporex, etc.), in order to protect public health. In 2009, sibutramine (Sibutral), an appetite suppressant structurally related to amphetamines, was also withdrawn by the EMA due to disproportionate and serious adverse drug reactions. And benfluorex (Mediator°) was also withdrawn from the whole European Union market in 2010.

For more details, go to: http://www.prescrire.org/Docu/DOCSEUROPE/20141219_ApprovalMysimba.pdf