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Original Report
Estimate of deaths due to valvular insufficiency attributable to the use of benfluorex in France
Article first published online: 9 FEB 2012
DOI: 10.1002/pds.3213
Copyright © 2012 John Wiley & Sons, Ltd.
Additional Information
How to Cite
Fournier, A. and Zureik, M. (2012), Estimate of deaths due to valvular insufficiency attributable to the use of benfluorex in France. Pharmacoepidem. Drug Safe., 21: 343–351. doi: 10.1002/pds.3213
Publication History
- Issue published online: 11 APR 2012
- Article first published online: 9 FEB 2012
- Manuscript Accepted: 13 DEC 2011
- Manuscript Revised: 12 DEC 2011
- Manuscript Received: 16 JUN 2011
- Abstract
- Article
- References
- Cited By
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.