Since 2009, agomelatine has been authorised as a treatment for depression despite its dubious efficacy beyond the placebo effect and its major adverse effects: hepatitis and pancreatitis, neuropsychological disorders (including suicides, aggressive behaviour, convulsions), muscular disorders, severe skin reactions, cardiac arrhythmia, etc.

Since the commercialisation of agomelatine, the patient leaflet for Valdoxan° has several times added further information about the hepatic adverse effects and hepatic function monitoring procedures. At the end of 2014, the European health authorities' umpteenth half-hearted measure consisted of requesting that healthcare professionals provide a "patient booklet".

The follow-up booklet that is proposed does not give quality information. It mentions briefly that agomelatine "could affect liver function" without giving details of the severity of this adverse effect.

Booklet or no booklet, the best way of preventing the hepatic adverse effects associated with agomelatine is to avoid it. The inclusion of a "patient booklet" does not alter the harm-benefit balance of agomelatine whose efficacy is too uncertain given the severe adverse effects associated with the drug. It is better to opt for a different, safer antidepressant.

©Prescrire 1 December 2015

"Agomelatine: to be avoided, with or without a "patient booklet"" Prescrire Int 2015; 24 (166): 294. (Pdf, subscribers only).