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France: AFSSAPS Updates Advice on Benfluorex Hydrochloride

The French pharmaceutical licencing board AFSSAPS or Agence française de sécurité sanitaire des produits de santé released an update on Tuesday 16th November 2010 regarding concerns over the safety of the diet drug for diabetics “Mediator”:

The Mediator ® (benfluorex hydrochloride) is a drug approved in 1976, initially classified and prescribed as a hypolipid drug. It was further approved in 1987 as an aid for dieting tailored to people with hypertriglyceridemia.

Then in 1990, a new use was identified for patients with diabetes: as an aid to dieting, suitable for people with diabetes and obesity.

In 1998, the laboratory applied to Afssaps for a new therapeutic indication for the treatment of type 2 diabetes in primary care.

This licence was not granted, for lack of efficacy data, especially when compared to other oral treatments for type 2 diabetes such as metformin.

The process of reassessment of the efficacy studies was then continued and led in 2007 to Afssaps withdrawing the use of Mediator as an adjunct to dieting in patients with hypertriglyceridemia, on the basis of a new study in the meantime.

In 2009, a new study to objectify the efficacy of benfluorex by adding another antidiabetic (Study Regulate), also included a section on the safety of this drug, in particular regarding possible adverse effects in the cardiovascular system.

It was looking for potential effects that may lead to pulmonary hypertension and heart valve leakage.
The results of this study contributed to the decision to withdrawal Mediator in November 2009.

The European Medicines Agency issued the following statement in December 2009:

The Agency’s Committee for Medicinal Products for Human Use (CHMP) reviewed available data on the safety and efficacy of these medicines because the French and Portuguese authorities had recalled them from their markets over safety concerns. The Committee concluded that the data indicate a risk of heart valve diseases associated with the use of benfluorex. The Committee also noted that the efficacy of benfluorex in the treatment of diabetes is limited. The Committee therefore was of the opinion that the benefits of these medicines no longer outweigh their risks and recommended the revocation of their marketing authorisations from all markets in the European Union.

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