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Anxiolytic drug etifoxine (Stresam°) causes too many severe adverse effects

The anxiolytic drug etifoxine causes adverse effects so severe that it should no longer be used.

In September 2012, the French drug regulatory agency published online a review on the adverse effects of etifoxine, prescribed as an anxiolytic (tranquillizer). Its chemical structure is different from that of other anxiolytic drugs, and its efficacy has not been thoroughly evaluated.

Between 2000 and 2012, 352 reports concerning this drug were analysed, including 125 reports of severe adverse effects.

A clear link has been established between etifoxine and liver toxicity and there are 34 reports mentioned in the review.

A large number of cutaneous effects and allergic reactions were also reported. Other notable adverse effects include colorectal damage and a severe decrease in platelets.

Several reports mention the efficacy of drugs co-administered with etifoxine being reduced. These include oral contraceptives and anticoagulants.

This amounts to a large number of adverse effects for a drug that has no proven efficacy.

The Agency has done its job in producing a review and making the information available to health professionals and patients. Now it must see this initiative through to the end and withdraw etifoxine from the market.

©Prescrire 1 March 2013

"Etifoxine: too many serious adverse effects" Prescrire Int 2013; 22 (136): 73. (Pdf, subscribers only).

Download the full review.
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