Agomelatine: clinical experience and adherence to EMA recommendations for a novel antidepressant

In 2009, the European Medicines Agency (EMA) granted marketing authorisation for the novel antidepressant agomelatine, with the recommendation that liver function tests (LFTs) are checked before, and 6, 12 and 24 weeks after, commencing the drug. This paper describes early clinical experience with agomelatine and audits physician adherence to EMA recommendations. A retrospective review of patients attending general adult psychiatry services in Carlow /Kilkenny (catchment population 120,000) over one year was performed. 62 patients were prescribed agomelatine. 32 patients (52%) had unipolar depression, and 43 (73%) were already established on antidepressant medication. 60 patients (97%) had LFTs measured before starting treatment with agomelatine, but half of patients (47%) did not have further LFTs as recommended. To increase adherence to EMA recommendations and ensure optimal patient safety, existing barriers to effective monitoring must be addressed.