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Mediator° - the criminal trial

Prescrire and Mediator° since 1986

 Timeline  Key dates in the Mediator° disaster, 1976-2019

First marketed in France in 1976, Mediator° (benfluorex) was not withdrawn from the French market until 2009, despite warnings published in Prescrire some 12 years earlier (October 2019)

 1976  Mediator diabèteServier markets benfluorex in France under the brand name Mediator°. Benfluorex belongs to the fenfluramine family of drugs, which are amphetamine derivatives. Its principal effect is appetite suppression, but it is mainly presented as an anti-diabetic and anti-"fat" agent.
 1995  Mediator coeurBenfluorex is prohibited in all magisterial preparations for weight loss, due to its cardiovascular risks, along with dozens of amphetamines. Mediator° remains on the market.
 1997  Mediator poumonsWorldwide market withdrawal of Servier's other fenfluramine appetite-suppressant drugs (brand names in France: Isoméride° and Pondéral°), since they are linked to serious pulmonary arterial hypertension (PAH) and valvular heart disease (VHD). Mediator° remains on the French market.
 1997  Mediator stopPrescrire observes that "there is currently no basis for treating non-insulin-dependent diabetics with benfluorex. The French health authorities should reconsider their decision to license and reimburse this product".
 1998  Mediator poidsA study by the Union régionale des caisses d'assurance maladie (Urcam) in France's Burgundy region shows that Mediator° is often prescribed along with a treatment for weight loss.
 1999  Mediator comprimésFirst reported cases of PAH and VHD in patients treated with Mediator°. Other cases will follow, up until 2009.
 1999  Mediator pharmacieWithdrawal from the French market of several amphetamine appetite-suppressant drugs. Mediator° remains on the French market.
 2000  Mediator mortelConfirmation that norfenfluramine, a molecule that is present in all fenfluramines, is the cause of their toxicity for the heart valves.
 2003, 2005, 2006, 2008, 2009  Mediator alertePrescrire repeatly warns of the risks of PAH and valvular heart disease linked to benfluorex, reasons for not using the drug and for withdrawing it from the market.
 2009  French market withdrawal of Mediator° following a pharmacovigilance alert issued by the Centre hospitalo-universitaire in Brest and passed along by the French national health insurance system (CNAM).
 Juin 2010  Mediator censureEuropean market withdrawal of Mediator°. Publication of the book entitled "Mediator° 150 mg, how many deaths?" (by Irène Frachon, éditions dialogues). The book's title is censored as a result of an interim order filed by Servier. It is restored upon appeal in 2011.
 Novembre 2010  Mediator faucheuse France's national health products authority (Afssaps) recognises that Mediator° is responsible for the death of at least 500 people.
 2011  Mediator étudeAn in-depth report by France's general inspectorate for social affairs (IGAS) is highly critical of public health authorities and of Servier.
 2014  Mediator administrationA French administrative court recognises the government's responsibility, "in spite of Servier's misconduct". This judgment is upheld on appeal by the Council of State in 2017.
 2015  Mediator justiceA first civil judgment against Servier recognises the harmful nature of Mediator°. This judgment is upheld on appeal, and again by the Court of Cassation in 2017.
 2019  Mediator victimesMore than 3 700 people, alive or deceased, are recognised as victims of Mediator° by France's national authority for the compensation of medical accidents (Oniam), establishing their right to compensation.
 23 September 2019  Mediator juge Opening of a criminal trial.  The company has been charged with "aggravated deception with endangerment of human life" and "involuntary injury and involuntary manslaughter through manifestly deliberate violations". The French medicines agency has been charged with "involuntary injury and involuntary manslaughter through negligence".
Excerpted from "Visages du Mediator" ("Faces of Mediator") Prescrire 2019,
202-203. > Learn more and order online

  See also:

  > Key texts around the Mediator° disaster 

  ©Prescrire October 2019

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