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The Mediator° scandal in France: key dates, key issues

Deaths caused by appetite suppressant Mediator° (benfluorex) made headlines in France last year, igniting a scandal that has led to a broad questioning of the country's medicines policy.

  • The scandal hit the headlines in October 2010, when French daily Le Figaro published the results of an official study estimating between 500 and 1000 deaths due to Mediator°, which causes pulmonary adverse effects and heart valve damage.
  • In June 2010, a book by pneumologist Irène Frachon had begun to reveal the extent of the damage caused by the drug, despite a lawsuit by Servier that forced the subtitle “How many deaths?” to be censored.
  • Mediator° (benfluorex) is an appetite suppressant of the amphetamine family. It went on sale in France in 1976. Officially marketed for use in diabetes and hypertriglyceridaemia, the drug was also widely prescribed as an appetite suppressant.
  • In a 1997 review, Prescrire pointed to the poor level of evidence and the dubious harm-benefit balance for benfluorex. Prescrire continued to caution against the use of the drug, including texts published in 2003, 2005, 2006, 2008 and 2009.
  • Spain withdrew the marketing authorisation for benfluorex in 2003.
  • France did not withdraw benfluorex from sale until November 2009.
  • The European Commission ruled in June 2010 that no pharmaceutical products containing benfluorex could be sold in the countries of the European Union.

  • In 2011, in the wake of the grave regulatory deficiencies revealed by the Mediator° scandal, several official audits and a national medicines conference “Les Assises du Médicament”  were set in motion. In August 2011 a draft law on medicines was published by the health ministry, and the French parliament is expected to act on it by the end of the year.
  • Prescrire has played an important role in these events, but declines to act in any kind of “official” capacity. Prescrire will maintain its wholly independent evaluation of medicines’ harm-benefit balances, and continue to monitor decisions by agencies and political authorities, into 2012 and beyond.

©Prescrire 1 November 2011

"The Mediator° scandal in France: key dates, key issues" Prescrire Int 2011; 20 (121): 280. (pdf, free)

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For further information:

Medicines policy in France after
the benfluorex (Mediator°) scandal:
the proposed measures are positive
but still need work, and especially
need to be implemented
(June 2011)

France's Mediator° scandal:
take the high road
(January 2011)
Mediator°: a book that spells
trouble for one drug company
(January 2011)

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