E-DRUG: Drugs used in weight control: first, do no harm
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Prescrire responded to EMA consultation on the revision of the guideline on medicinal products used in weight control Response to an EMA public consultation
Dear E-Druggers
In its response to the European Medicines Agency's consultation on the revision of the guideline on medicinal products used in weight control, Prescrire would like to remind the EMA of the importance of the principle: "first, do no harm". 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 lost weight is very often regained within months of discontinuing the treatment.
Taking on board the lessons learnt from past public health disasters notably due to drugs with appetite suppressant effects, such as sibutramine (Sibutral°) and benfluorex (Mediator°), and to rimonabant (Acomplia°), Prescrire urges the European Medicines Agency to impose stricter requirements so that weight-control medicines that do more harm than good can no longer be authorised in Europe.
Prescrire urges the EMA to impose stricter requirements so that the new guideline represents a tangible improvement over the one adopted in 2007.
It is time, at the end of 2012, to learn from past drug disasters caused by appetite suppressants, including sibutramine (Sibutral°, now withdrawn) and benfluorex (Mediator°, now withdrawn), and by rimonabant (Acomplia°, now withdrawn), and to stop exposing European patients to the adverse effects of weight-control medicines that do more harm than good.
See Prescrire's response at: http://english.prescrire.org/en/79/207/46302/2374/1884/SubReportDetails.aspx
Christophe Kopp
Editor with Prescrire
Website: english.prescrire.org
ckopp@prescrire.org