Benfluorex: carnifex, when ex?


Benfluorex (Médiator®) is an amphetamine derivative with significant toxic effects recognized yet on sale in France for more than thirty years.

It is part of the class of anorectics indicated in diabetes and hyperlipidaemia, and whose subsequent dependence on their consumption and the dangerousness of the side effects have caused most of the molecules chemically similar to benfluorex to be withdrawn from the market. For example neuropsychiatric disorders, pulmonary arterial hypertension, valvular heart disease, to name only those specific to benfluorex.

Members of the National Pharmacovigilance Commission of the French Agency for Sanitary Safety of Health Products meeting on March 27, 2007 made a point of making known their opinion by pronouncing themselves in favor of an inverted benefit/risk ratio of the Médiator®, of an efficiency considered only “modest”. But at the outcome of their meeting, there was only the issuance of an unfavorable opinion on the maintenance of the indication “adjuvant to the adapted diet in hypertriglyceridemia”. The other indications have therefore been retained, despite the non-renewal of the Marketing Authorization (MA) already executed in Spain and Italy. The sales of Médiator® accounted for in Europe are also made almost entirely in France.

Finally, misuse is feared, particularly in obesity, and cases of addiction and doping have already been reported (the substance is prohibited in the Official Journal of March 7, 2000). In France, patients continue to be exposed to its listed adverse effects, until when?

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