Benfluorex

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Benfluorex
Clinical data
Trade namesMediator
AHFS/Drugs.comInternational Drug Names
Routes of
administration		By mouth
ATC code
Legal status
Legal status
Pharmacokinetic data
ExcretionKidney
Identifiers
  • (RS)-2-({1-[3-(trifluoromethyl)phenyl]propan- 2-yl}amino)ethyl benzoate
JSmol)
ChiralityRacemic mixture
  • FC(F)(F)c1cccc(c1)CC(NCCOC(=O)c2ccccc2)C
  • InChI=1S/C19H20F3NO2/c1-14(12-15-6-5-9-17(13-15)19(20,21)22)23-10-11-25-18(24)16-7-3-2-4-8-16/h2-9,13-14,23H,10-12H2,1H3 checkY
  • Key:CJAVTWRYCDNHSM-UHFFFAOYSA-N checkY
 ☒NcheckY (what is this?)  (verify)

Benfluorex, sold under the brand name Mediator, is an

type-2 diabetes.[2][3]

It was on the market between 1976 and 2009, and is thought to have caused between 500 and 2,000 deaths.

Servier. However, Servier is suspected of having marketed benfluorex at odds with the drug's medical properties.[5]

On March 29, 2021, a French court fined Servier €2.7m (£2.3m) after finding it guilty of deception and manslaughter.[6]

Drug withdrawn

On 18 December 2009, the

heart valve disease (fenfluramine-like cardiovascular side effects), are greater than their benefits.[7] Thus Frachon et al. showed a higher rate of unexplained valvular heart disease in people taking benfluorex.[8] Weill et al. looked at over 1 million people with diabetes demonstrating a higher hospitalization rate in benfluorex takers for valvular heart disease.[9]
In France, the medication had been marketed by Servier as an adjuvant
antidiabetic under the name Mediator. The drug was on the market between 1976 and 2009, and is thought to have caused between 500 and 2,000 deaths.[4]
The drug was also used in Spain, Portugal, and Cyprus.

On March 29, 2021, a French court fined Servier €2.7m (£2.3m) after finding it guilty of deception and manslaughter, with Mediator linked to the deaths of up to 2,000 people. The former executive Jean-Philippe Seta was sentenced to a suspended jail sentence of four years. The French medicines agency, accused of failing to act quickly enough on warnings about the drug, was fined €303,000. The pharmaceutical group was acquitted of charges of fraud. [10]

Fenfluramine, a related drug, had been withdrawn from the market in 1997 after reports of heart valve disease,[11][12] pulmonary hypertension, and development of cardiac fibrosis. This side effect is mediated by the metabolite norfenfluramine on 5HT2B receptors of heart valves,[13] leading to a characteristic pattern of heart failure following proliferation of cardiac fibroblasts on the tricuspid valve. Both fenfluramine and benfluorex form norfenfluramine as a metabolite. This side effect led to the withdrawal of fenfluramine as an anorectic drug worldwide, and later to the withdrawal of benfluorex in Europe.

References

  1. ^ Anvisa (2023-03-31). "RDC Nº 784 - Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial" [Collegiate Board Resolution No. 784 - Lists of Narcotic, Psychotropic, Precursor, and Other Substances under Special Control] (in Brazilian Portuguese). Diário Oficial da União (published 2023-04-04). Archived from the original on 2023-08-03. Retrieved 2023-08-16.
  2. PMID 16505498
    .
  3. PMID 10432168
    .
  4. ^ a b "France braced for diabetic drug scandal report". BBC News. 2011-01-11.
  5. S2CID 5325085
    .
  6. ^ "Mediator drug: French pharmaceutical firm fined over weight loss pill". BBC News. 29 March 2021.
  7. ^ "European Medicines Agency recommends withdrawal of benfluorex from the market in European Union" (PDF). European Medicines Agency. 2009-12-18. Archived from the original (PDF) on 2009-12-22. Retrieved 2015-01-12.
  8. PMID 20405030
    .
  9. S2CID 15979457
    .
  10. TheGuardian.com
    . 29 March 2021.
  11. PMID 9271479
    .
  12. S2CID 46466276
    .
  13. PMID 11104741
    .
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