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calendary February 1, 2024

Servier was fined for selling the drug Mediator

The court ordered drug manufacturer Servier to pay 424 million euros for the sale of the drug Mediator (benfluorex), the use of which can cause serious side effects for patients.

Mediator (benfluorex) was first registered in France by Servier in 1976. The drug is a selective serotonin reuptake inhibitor that can suppress appetite. The drug was prescribed mainly to patients with diabetes to control blood sugar levels. However, then the drug began to be taken by obese people for the purpose of weight loss. In 1997, Servier's other appetite suppressant drugs (Isoméride and Pondéral) were withdrawn worldwide because they were associated with pulmonary arterial hypertension (PAH) and valvular heart disease (VHD). At the same time, the drug Mediator remained on the market.

The fact that Mediator can also cause PAH and VHD first became known in 1999, and in 2000 evidence was obtained that the molecule in the core of the active substance of the drug Mediator - norfenfluramine - has a toxic effect on the heart valves. However, the drug remained on the French market until 2009. Mediator was withdrawn as a result of the efforts of pulmonologist Irène Frachon, who published a large-scale study on the negative effects of the drug on the cardiovascular system.

According to various sources, taking the drug Mediator caused deaths of 500 – 2,000 people. Millions of people administered the drug.

Servier was eventually found guilty of fraud and improperly obtaining marketing authorization. During the trial in the trial court, Servier was acquitted on these counts in 2021. However, in 2023, the appeal court imposed a fine of €9.1 million. In addition, the company will have to pay €415 million in compensation to social security authorities and mutual insurance companies.

The trial began in France in 2019. The defendants were 11 legal entities and 12 individuals, including the Servier laboratory and 9 of its branches, as well as the ANSM agency, which, despite numerous complaints and studies indicating great harm to health from this product, banned its sale only in 2009. On March 29, 2021, a Paris court found Servier guilty of aggravated deception and manslaughter and bodily harm.

References:
  1. https://pharmvestnik.ru/content/news/Sud-Francii-naznachil-shtraf-Servier-za-prodaju-opasnogo-dlya-zdorovya-preparata-ot-ojireniya.html
  2. https://english.prescrire.org/en/221/1932/57597/0/PositionDetails.aspx
  3. https://tass.ru/obschestvo/19596079

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