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Etifoxine: a dangerous drug still on the market

The European reassessment of etifoxine, a dangerous drug with no demonstrated efficacy, has only led to some modifications of the summary of product characteristics (SmPC) and the package leaflet.

  • Etifoxine is a psychotropic drug authorised in France as an anxiolytic.
     
  • It has no demonstrated efficacy beyond that of a placebo, but it can cause serious adverse effects, such as hepatitis and hypersensitivity reactions (including DRESS syndrome).
     
  • In early 2022, on the advice of the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), the European Commission decided that etifoxine could continue to be authorised for anxiety disorders.
EDITORS' OPINION
Etifoxine "perhaps not lacking efficacy": when doubt benefits the company, and not patients

Patients and healthcare professionals expect marketing authorisation (MA) to guarantee that the authorised drug has proven efficacy, if not versus a relevant comparator, then at least versus placebo. They also have a right to expect the MA to guarantee that the adverse effect profile of the drug will be acceptable.

After noting the inadequacies in the evaluation of etifoxine over many decades, and having recognised the uncertainties surrounding its efficacy, the Committee for Medicinal Products for Human Use (CHMP) nevertheless took the view that the company did not have to demonstrate that their drug was effective in order for it to remain on the market...

Full text available for download below.

©Prescrire 1 November 2022

Source: "Etifoxine: no justification for keeping it on the market" Prescrire International 2022; 31 (242): 277-278. Subscribers only.

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