english.prescrire.org > Spotlight > Archives : 2013 > Depression: avoid agomelatine (Valdoxan° and other brands)

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Depression: avoid agomelatine (Valdoxan° and other brands)

The harm-benefit balance of the antidepressant agomelatine is markedly unfavourable.

Despite the absence of any proven efficacy, agomelatine has been commercialised since 2009 for the treatment of depression. Since then, it has been the subject of a European Medicines Agency Risk Management Plan and reinforced monitoring.

Prescrire requested and obtained pharmacovigilance reports from the French drug regulatory agency and the European Medicines Agency.

Large amounts of data were unclear and some details of the reports were redacted. However, the new evidence confirms agomelatine’s adverse effects profile, which already gave cause for concern during the pre-commercialisation clinical trials.

Some adverse effects are particularly severe, including liver and pancreatic damage, neuropsychological disorders leading to suicide, aggressive behaviour, convulsions and vertigo, as well as sometimes severe muscular damage. Other worrying disorders have been reported, such as severe cutaneous reactions and cardiovascular disorders, and the possibility of a cancer risk.

In the absence of any proven benefits, these combined data confirm that agomelatine’s harm-benefit balance is markedly unfavourable.

Until drug regulatory agencies disseminate this information widely and decide to withdraw this drug from the market, health professionals should avoid prescribing agomelatine to patients.

©Prescrire 1 March 2013

"Agomelatine: a review of adverse effects" Prescrire Int 2013; 22 (136): 70-71. (Pdf, subscribers only).

Download the full review.
Pdf, subscribers only