in its August 2022 issue.
Authorized in France as an anxiolytic, etifoxine
has no demonstrated efficacy beyond that of a placebo, while it exposes to serious adverse effects, such as hepatitis and hypersensitivity reactions“, reports the review.
In 2019, the French Medicines Agency (ANSM) concluded that etifoxine had an unfavorable benefit-risk balance, then requested the European reassessment of the drug.
Following an opinion from the French High Authority for Health (HAS) in 2020, which noted a lack of demonstration of efficacy and rare but serious adverse effects, the drug is no longer reimbursable by Social Security since the end of 2021.
At the beginning of 2022, the European Commission decided, on the advice of the Marketing Authorization Committee (CHMP) of the European Medicines Agency (EMA), that etifoxine can continue to be authorized in anxiety disorders, with simple modifications of its official information: addition of contraindications and warnings in the instructions. And on condition that the firm provides the results of an additional “well-designed and sufficiently powerful” clinical trial by… March 2027.»
In terms of efficacy, the CHMP has indeed pointed to the shortcomings of the clinical trials conducted with etifoxine before its marketing, but surprisingly concludes that “the results are not considered sufficiently solid to establish that etifoxine lacked efficacy ”.»
“Firms therefore do not have to demonstrate that their drug is effective for it to be maintained on the market. It is enough that the CHMP is not sure of the ineffectiveness of the medicine. And the proven risks of liver damage and serious hypersensitivity reactions, recognized by the CHMP, do not change the situation. In other words, a drug that has no proven efficacy but whose risks are proven remains on the market.»
For a very long time, caregivers have been asked to “first do no harm to the patient”. In 2022, the European drug authorities prefer first of all not to harm the companies“, concludes the review.
Etifoxine (Stresam) is part of the list of more dangerous than useful drugs that Prescrire updates every year.
When an anxiolytic is warranted, a benzodiazepine for the shortest possible duration is a better choice. It is prudent to consider from the outset with the patient the conditions and methods for stopping the drug in order to reduce the risks associated with prolonged use.“, specifies the review.
Xanax (alprazolam) and Lexomil (bromazepam), for example, are benzodiazepines (listing).
For more information, see the links below.
Psychomedia with sources: Prescrire, Prescrire, HAS.
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