By Ed Silverman // November 17th, 2010
A diabetes drug called Mediator that had been used for decades - but was banned just a year ago over links to heart-valve damage - is now being linked by French authorities to some 500 deaths. Mediator, which is also known as benfluorex and was sold by Servier, was also used as an appetite supressant and had already been banned in the US, Spain and Italy.
“Our message to all those who took Mediator is that they must see a doctor, particularly those who took it for three months over the past four years,” Health Minister Xavier Bertrand told journalists in France after the French regulatory agency, Afssaps, issued its warning and recommendations (see this).
For its part, Servier rejected the estimated number of deaths as “theories founded on extrapolation” and argued that 2.5 percent of the population had valve trouble, adding that age and diabetes heightened the risk. “Simply observing a valve problem in a diabetic person does not allow it to be attributed to medicinal treatment which remains a very rare cause,” the drugmaker says in a statement (which apparently has not yet been placed on its web site). A Servier spokesman tells Agence France-Presse just four patients had lodged complaints about Mediator since 2009 and that 500 deaths represented a tiny risk compared to the number of people who took the drug. “But in terms of brand image, it’s disagreeable,” he adds.
Irene Frachon, a doctor who earlier this year published a study warning about the drug, told AFP that “Mediator is responsible for a health disaster…The health authorities were late in withdrawing this drug despite several alerts” about threats it posed to the heart valves. I know personally some of the victims and what they have suffered. Some of them have undergone open heart surgery and they have to take lots of medication.” She estimates 80 percent were women.
A similar Servier drug, the appetite-suppressor Isomeride, was withdrawn in 1997 after tests showed it raised the risk of high blood pressure, AFP writes. The drug spawned several lawsuits against Servier. Afssaps adds that 11 cases of valve damage in patients taking Isomeride were reported to drug safety authorities in France between 1997 and 2006. As it so happens, AFP notes that was the same year in which the confirmed case of heart valve damage caused by Mediator was confirmed.