Estimate of deaths due to valvular insufficiency attributable to the use of benfluorex in France.
OBJECTIVE
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.
INSERM, CESP Centre for Research in Epidemiology and Population Health, U1018, Nutrition, Hormones and Women's Health Team, Villejuif, France.
Agnès
A
Fournier
Mahmoud
M
Zureik
D000328:Adult; D000368:Aged; D001067:Appetite Depressants / Q000009:adverse effects*; D015331:Cohort Studies; D016208:Databases, Factual; D005260:Female; D005277:Fenfluramine / Q000009:adverse effects / Q000031:analogs & derivatives*; D005602:France / Q000453:epidemiology; D006349:Heart Valve Diseases / Q000139:chemically induced* / Q000453:epidemiology / Q000401:mortality; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged
D001067:Appetite Depressants; D005277:Fenfluramine; C001584:benfluorex