Benfluorex and Mortality: A Fresh Perspective

Abstract

Benfluorex, a drug related to fenfluramine, has been sold under the trade name “Mediator” by Servier Laboratories and was introduced to the French market in 1976, licenced for the treatment of type 2 diabetes and dyslipidemia. Although the evidence that benfluorex increases the risk of mild valvular regurgitant abnormalities is convincing, it is also apparent that no data exist from which to calculate the risk of death attributable to benfluorex use. Despite this, two studies have attempted to make such estimates, the results of which have been the focus of much media attention. In this review, we attempt to provide a further assessment of the evidence base, explore the limitations of the estimates of death that have been made, and calculate the population risk of mild valvular regurgitation and hospitalisation attributable to benfluorex use. We conclude that the previously published estimates of deaths attributed to the use of this agent are unsafe, based on unfounded assumptions, and are highly likely to be inaccurate.