1976  Servier 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 antidiabetic and anti-"fat" agent. |
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1995  Benfluorex is prohibited in all extemporaneous preparations for weight loss, due to its cardiovascular risks, along with dozens of amphetamines. Mediator° remains on the market. |
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1997  Worldwide 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. |
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1997  Prescrire 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". |
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1998  A 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. |
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1999  First reported cases of PAH and VHD in patients treated with Mediator°. Other cases will follow, up until 2009. |
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1999  Withdrawal from the French market of several amphetamine appetite-suppressant drugs. Mediator° remains on the French market. |
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2000  Confirmation that norfenfluramine, a molecule that is present in all fenfluramines, is the cause of their toxicity for the heart valves. |
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2003, 2005, 2006, 2008, 2009  Prescrire repeatedly warns of the risks of PAH and valvular heart disease linked to benfluorex, which warrant avoiding the drug and its withdrawal from the market. |
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| 2009 French market withdrawal of Mediator° following a pharmacovigilance alert issued by Brest University Hospital and passed along by the French national health insurance system (CNAM). |
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Juin 2010  European 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. |
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Novembre 2010  France's national health products authority (Afssaps) recognises that Mediator° is responsible for the death of at least 500 people. |
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2011  An in-depth report by France's General Inspectorate for Social Affairs (IGAS) is highly critical of public health authorities and of Servier. |
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2014  A 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. |
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2015  A 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. |
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2019  More than 3700 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. |
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2019-2021  Initial criminal trial The pharmaceutical company Servier and its former chief executive, Jean-Philippe Seta, were convicted of "aggravated deception" and “involuntary bodily harm and manslaughter”, but no custodial sentences were handed down. |
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| December 2023 Mediator° trial appeal Servier found guilty on all counts (including improperly obtaining and fraudulently renewing marketing authorisation and defrauding health insurance providers). Jean-Philippe Seta was given a 4-year suspended prison sentence. Again, this sentence was subject to appeal. |
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Excerpted from "Visages du Mediator" ("Faces of Mediator") Prescrire 2019,
202-203. > Learn more and order online
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See also:
> Key texts around the Mediator° disaster
©Prescrire July 2024
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