[Number of deaths attributable to benfluorex]

Benfluorex has been withdrawn from the French market in November 2009, after more than 30 years of use. The estimation of the number of deaths attributable to this drug has been the subject of vigorous debates. To clarify the problem, we describe the difference between the concepts of "imputabilité" and attributable mortality. "Imputabilité" is used by the French pharmacosurveillance system to analyse the plausibility of the association between exposure to the drug and adverse drug reaction for a given patient. The attributable mortality is estimated at the population level, once the association between drug exposure and adverse drug reaction has been demonstrated. We summarise the evidence providing the basis of this demonstration, and describe in detail the computation of our estimation of 500 deaths attributable to benfluorex.