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Keywords:

  • benfluorex;
  • fenfluramine derivative;
  • valvular heart disease;
  • pharmacoepidemiology

ABSTRACT

Purpose

To estimate the number of deaths from valvular insufficiency caused by the use of the fenfluramine-derivative benfluorex during the period 1976–2009 in France.

Methods

Our calculation was based on (i) the exposure level to benfluorex in the French population, derived from sales figures for the period 1976–2009 and from the main characteristics of benfluorex use provided by the French health products safety agency; (ii) the relative risk of hospitalization for valvular insufficiency among exposed compared with unexposed individuals with diabetes, originating from a cohort study based on a French medico-administrative database, with benfluorex exposure assessed in 2006; (iii) the incidence of hospitalization for valvular insufficiency among exposed individuals, originating from the same database; and (iv) the mortality associated with valvular heart disease.

Results

In France, use of benfluorex during the period 1976–2009 is likely to be responsible for around 3100 hospitalizations and 1300 deaths due to valvular insufficiency. These figures may be underestimations.

Conclusions

The grave consequences benfluorex use have had for many people lend support to the public investigation, which has been set to understand the reasons that have contributed to the delay in withdrawing benfluorex from the French market. Copyright © 2012 John Wiley & Sons, Ltd.