Impending approval of a dangerous amphetamine drug for use in weight control? An unacceptable EMA recommendation that must be overturned.
PRESS RELEASE – Paris, 19 December 2014.
” 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 (2). In 2009, sibutramine (Sibutral), an appetite suppressant structurally related to amphetamines, was also withdrawn by the EMA due to disproportionate and serious adverse drug reactions. And benfluorex (Mediator) was also withdrawn from the whole European Union market in 2010.
In addition, in 2013, the EMA rightly refused to authorise the dangerous fixed-dose combination phentermine + topiramate on safety grounds, and the application for the drug lorcaserin (Belviq) was withdrawn by the company following the CHMP’s “provisional opinion that Belviq could not have been approved for weight control in obese and overweight patients”. How is it possible that the CHMP now takes an incongruent decision on the fixed-dose weight-control combination naltrexone + amfebutamone (also known as bupropion) (CONTRAVE/MYSIMBA)?
Health authorities should learn from past public health disasters. A weight loss of a few kilograms achieved through drug therapy cannot in itself justify exposing obese or simply overweight patients to a disproportionate risk of adverse drug reactions, especially since the weight lost is very often regained within months of discontinuing treatment.
Health authorities should learn the lessons from past public health disasters, notably those due to several appetite suppressants subsequently withdrawn from the EU market for disproportionate and serious adverse drug reactions (sibutramine (Sibutral), benfluorex (Mediator), rimonabant (Acomplia)).
Prescrire urges national Drug Regulatory Agencies’ representatives with a seat at the CHMP and who voted against the recommendation on naltrexone + amfebutamone (CONTRAVE/MYSIMBA) to insist that patients’ safety be defended. Member States opposing the recommendation still can and should require arbitration by the European Commission and convene a standing Committee meeting. The EU Commission, as last gatekeeper, also has the possibility of deciding not to follow the CHMP’s recommendation.
In 2015, weight-control medicines that do more harm than good should no longer be authorised in the European Union. ”
Sources and more information
- Impending approval of a dangerous amphetamine drug for use in weight control? An unacceptable EMA recommendation that must be overturned, prescrire, 19 December 2014. See also the press release PDF.
- Mysimba recommended for approval in weight management in adults, EMA, 19/12/2014. See also the press release PDF.
- FDA approves weight-management drug Contrave, FDA news, September 10, 2014.