Over 1300 Deaths in Mediator Scandal in France

February 10, 2012

February 9, 2012 (Villejuif, France) — The number of deaths attributable to heart-valve insufficiency as a result of the use of benfluorex (Mediator, Servier) in France is much greater than previously thought, say two French researchers [1]. They estimate that 3100 people were hospitalized and over 1300 died due to valvular insufficiency associated with benfluorex use in the country during the period from 1976 to 2009.

And these figures are likely underestimates, say Drs Agnes Fournier (INSERM, Villejuif, France) and Mahmoud Zureik (INSERM Paris, France) in a report published online February 9, 2012 in Pharmacoepidemiology & Drug Safety. Prior guesses at the number of deaths associated with benfluorex have hovered around the 500 mark.

"Despite its similarity with the two appetite suppressants fenfluramine and dexfenfluramine, benfluorex was kept on the market for more than 30 years in France," say Fournier and Zureik. "Given the grave consequences benfluorex use has had for many people, a public investigation has been set in France to understand the reasons that have contributed to the delay in withdrawing benfluorex from the market and to stress needed reform of drug regulation."

This paper comes just a few days after investigators searched the offices of French healthcare regulator AFSSAPS (French Agency for Safety of Health Products), which is under scrutiny for allowing the sale of benfluorex in France long after it had been pulled from the market elsewhere, according to a Reuters report [2].

Benfluorex Use Was Off-Label for More Than Three Decades in France

Benfluorex was marketed in France for more than 30 years, from 1976 to 2009, as an adjunct for the treatment of hyperlipidemia and among overweight patients with type 2 diabetes. Although it had anorexic properties, the drug was not marketed as an appetite suppressant, but it was used off-label for this purpose.

The drug continued to be prescribed in France throughout the early 2000s despite the fact that, in the late 1990s, fenfluramine and dexfenfluramine were withdrawn from the European and US markets because they were responsible for pulmonary hypertension and valvular insufficiency. Benfluorex was eventually withdrawn from the market in France in 2009.

Now, Fournier and Zureik have calculated what they believe is a more realistic estimate of deaths and hospitalizations due to the drug's use there.

They have based this on exposure levels to benfluorex in the French population--derived from sales figures for the entire period it was marketed and from characteristics of its use provided by AFSSAPS; the relative risk of hospitalization for valvular insufficiency among benfluorex-exposed compared with unexposed individuals with diabetes in 2006; the incidence of hospitalization for valvular insufficiency among exposed individuals; and the mortality associated with valvular heart disease.

And these new figures are likely underestimates, they say, because they do not take into account deaths from primary pulmonary hypertension that benfluorex "may also well have caused."

"French citizens, practitioners, politicians, and public-health actors are seeking to understand why the French health-products safety agency took so long to withdraw this drug, which was of very limited efficacy and was dangerous," comments Zureik in a statement [3].

Authors declare no relevant conflicts of interest.

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