It took years for France to pull Mediator (benfluorex) from its market. But why did it take so long for the French Regulatory Authority, Afssaps, to force Servier to remove it from the Market in 2009? The drug was being used for weight loss. It was developed by the French pharma company, Servier, and approved by Regulators 35 years ago. The drug, however was said to have been the cause of death for 2000 people.In 1999 there was an official report that Mediator could cause heart disease, yet it stayed on the French market for an additional 10 years. What could be the reason?
In 2000, according to Martine Verdier, an attorney representing victims, "there was a scientific study that demonstrated the side effects." Valvular heart disease was the issue. This is not the first time that there was an association between a medication being used for weight loss and valvular heart disease and associated pulmonary hypertension. In fact, according to The New York Times there were two other Servier wight-loss medications, which were closely related to Mediator that were at the center of the infamous fen-phen scandal in the late 1990s in the United States.
Mediator (benfluorex) is an amphetamine derivative. Fenfluramine and dexfenfluramine are amphetamine derivatives and were licensed to companies in the US and then marketed by Wyeth as the drug combination for wight loss. In September 1997 the FDA announced the withdrawal of fenfluramine and dexfenfluramine. Dexfenfluramine was manufactured for Interneuron Pharmaceuticals and marketed under the name of Redux by Wyeth, which also manufactured and marketed fenfluramine under the brand name Pondimin. Both companies agreed to voluntarily withdraw their drugs. Nevertheless, Mediator remained available to the French public.
Servier stands accused of misleading the public over the ingredients of the Mediator. The French government has accused the company of consumer fraud and manslaughter. After Servier was granted a market approval for Mediator as a diabetes drug, it promoted the drug as a prescription for weight loss. This was done to increase the sales of the drug, unfortunately it also increased the number of patients harmed.
Following this scandal, the head of the French equivalent to the FDA known as Afssaps resigned. France has since implemented reforms to Afssaps, which is now known as Ansm. The new French National Agency of Medicine and Health Products Safety is hoped to revamp the French Regulatory Agency and establish new trust and confidence following the scandal over Mediator.
