EMA has started a review of Stresam (etifoxine), a medicine authorised in some EU countries for the treatment of anxiety disorders. 

EMA’s review follows the findings of a new study (AMETIS) on the effectiveness of Stresam in treating adjustment disorders (difficulty coping with a stressful event) with anxiety. The results of the study suggest that Stresam had similar effects to placebo (a dummy treatment). 

In addition, an analysis of the available safety data for Stresam, including data from the AMETIS study and that collected through safety monitoring, found that some rare but serious side effects were still occurring, despite measures taken in 2014 to minimise their risk. They include serious skin reactions, liver damage, uterine bleeding between menstrual periods (mainly in women using oral contraceptives), and inflammation of the gut (lymphocytic colitis).  

As a result, the French medicines agency requested a review of the benefits of Stresam in the context of the medicine’s risks. EMA will now assess the available data and recommend whether the marketing authorisations for this product should be maintained, varied, suspended or revoked.