Post-authorization safety study on agomelatine and the risk of hospitalization for acute liver injury


Agomelatine (Valdoxan, Thymanax) is a melatonergic agonist and 5-HT2C antagonist which is, among other antidepressants, indicated for major depressive episodes in adults. Its marketing authorisation was granted in the European Union in 2009. Since Agomelatine is associated with a high potential for acute liver injury (ALI), the European risk-management-plan includes a Post-Authorization-Safety-Study to investigate the risk of ALI in users of Agomelatine compared to users of other frequently prescribed antidepressants.

Based on the German Pharmacoepidemiological Research Database (GePaRD), a cohort study will be performed to estimate incidence rates of acute liver injury for users of agomelatine and users of other commonly used antidepressants compared to citalopram. In a nested case-control analysis, confounder adjusted odds ratios of acute liver injury in new users of agomelatine and other antidepressants will additionally be compared with new users of citalopram with the main outcome of hospitalizations due to ALI. Also, a more unspecific definition considering outpatient diagnoses of ALI will be tested.

This study is coordinated by the non-profit organization RTI Health Solutions and concurrently is also conducted in databases from Spain, Denmark and Sweden.

Funding period

Begin:   August 2014
End:   December 2018


  • Pharmaceutical industry


Dr. rer. medic. Tania Schink