(HealthDay News) – Benfluorex (Mediator), a fenfluramine-derivative drug used in France for the treatment of high cholesterol in overweight patients with diabetes, is likely to have been responsible for thousands of hospitalizations and deaths over a 30-year period, according to a study published online Feb. 9 in Pharmacoepidemiology & Drug Safety.
Agnès Fournier, PhD, from the Institute National de la Santé et de la Recherche Médicale (INSERM) in Villejuif, and Mahmoud Zureik, MD, PhD, from the INSERM in Paris – both in France, estimated the number of deaths from valvular insufficiency due to use of benfluorex from 1976–2009 in France. The estimate was based on the following: calculations of the exposure level to benfluorex in the French population, derived from sales figures and from the characteristics of benfluorex use provided by the French health products safety agency; the relative risk of hospitalization for valvular insufficiency among exposed versus unexposed individuals with diabetes, based on a 2006 French medico-administrative database; the incidence of hospitalization for valvular insufficiency among exposed individuals, originating from the same database; and mortality linked to valvular heart disease.
The researchers found that the use of benfluorex was likely responsible for approximately 3,100 hospitalizations and 1,300 deaths due to valvular insufficiency. However, these figures may be lower than the actual numbers.
“In conclusion, despite its similarities with the two appetite suppressants fenfluramine and dexfenfluramine, benfluorex was kept on the market for more than 30 years in France, where it is likely to be responsible for more than 1,000 deaths from valvular insufficiency,” the authors write. “This figure does not take into account the deaths from primary pulmonary hypertension it may also have caused.”