Servier denies hiding risks of withdrawn diabetes drug

France's Servier is denying government allegations that it hid the risks of a drug marketed for diabetes, which now has been linked to the deaths of as many as 2,000 people. The accusations emerged in January, when the French Inspection Generale des Affaires Sociales said Servier had sold its drug benfluorex as a diabetes treatment, when it was really an appetite suppressant closely related to the notorious diet drug fenfluramine.

Servier said the government report was wrong. "Benfluorex is not a fenfluramine in disguise," the company said in a document made public today (as quoted by Bloomberg). Sold under the brand name Mediator until it was withdrawn in November 2009, the drug has a chemical structure similar to fenfluramine, but works differently, the company said. The drug was often prescribed off-label as a diet drug, but the company says it cannot be blamed for that.

The company also disputed the estimate of deaths attributed to Mediator: between 500 and 2,000, as calculated by the French health-insurance agency Caisse Nationale de l'Assurance Maladie. Servier said it was impossible to determine how many patients might have died from heart-valve damage caused by the drug: "To this day, and notwithstanding the figures cited, no pertinent study makes it possible," Servier said.

The company has acknowledged that Mediator may have increased the risk of heart-valve damage. But it says it never concealed those risks. "We always were transparent with regulators," the company said in an emailed document. "We acted responsibly throughout the entire life of this medicine."

- read the Bloomberg story
- get more from Pharmalot