Servier Denies French Allegation of Concealing Mediator Diabetes Drug Risk - (Bloomberg via NewsPoints Desk)

  • Les Laboratoires Servier denied allegations by French government investigators that the company concealed the risks of the drug Mediator (benfluorex hydrochloride), which is now suspected of having caused the deaths of as many as 2000 people, Bloomberg reported Sunday.
  • A government investigative agency said that Servier depicted Mediator, which was sold in France for 33 years until it was pulled from the market in November 2009, as a diabetes treatment, when in reality it was a "potent" appetite suppressant closely related to the withdrawn agent fenfluramine.
  • Servier countered that the report is mistaken and biased, and the agency didn’t request the drugmaker to provide clinical data that could have led to more accurate conclusions, adding that "benfluorex is not a fenfluramine in disguise."
  • "We always were transparent with regulators," the drugmaker said noting that the company "acted responsibly throughout the entire life of this medicine," which it said has a chemical structure similar to that of fenfluramine, but work differently once inside the body.
  • "To this day, and notwithstanding the figures cited, no pertinent study makes it possible to estimate with precision the number of patients who may have died of heart-valve damage caused by Mediator," the company said.
  • Servier suggested that the drug was often prescribed by doctors in France as a treatment to lose weight, an indication for which it didn’t have approval, something that "cannot be blamed on Servier," the company said.

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