Suicidality as Rare Adverse Event of Antidepressant Medication: Report From the AMSP Multicenter Drug Safety Surveillance Project

Objective: Since the advent of antidepressant drug treatment, the question of whether these substances induce suicidal ideation and behavior has not been satisfactorily answered. The aim of this study is to contribute to this ongoing discussion by taking a heuristic case-based approach to the question.

Method: A large data set from a European drug surveillance program (Arzneimittelsicherheit in der Psychiatrie; AMSP) performed in 85 psychiatric hospitals from 1993 until 2008 was analyzed. A series of single cases were carefully assessed. The observed frequencies of adverse drug reactions (ADRs) in this sample were related to the total AMSP population, who used the imputed medication.

Results: A total of 142,090 adult patients taking antidepressant medication were observed. Thirty-three incidents of suicidality (12 cases of suicidal ideation, 18 attempts, and 3 completed suicides) were documented. Fourteen cases were assumed to be probably, and 19 to be possibly, related to the drug. Twenty-three cases judged as suicidal ADRs were associated with restlessness, 10 with ego-dystonia, 9 with impulsiveness, and 3 with psychosis. A higher incidence of suicidal ADRs was observed for selective serotonin reuptake inhibitors (0.034%; 95% CI, 0.020-0.054) and serotonin-norepinephrine reuptake inhibitors (0.034%; 95% CI, 0.015-0.068) compared to noradrenergic and specific serotonergic antidepressants (0.009%; 95% CI, 0.002-0.027) and tricyclic antidepressants (0.002%; 95% CI, 0.000-0.014).

Conclusion: Despite the methodological limitations of this study, the large AMSP data set supports the assumption that antidepressant drugs rarely trigger suicidality.

J Clin Psychiatry

Submitted: December 15, 2009; accepted March 31, 2010.

Online ahead of print: August 10, 2010 (doi:10.4088/JCP.09m05912blu).

Corresponding author: Susanne Stübner, PD Dr, Department of Psychiatry, Ludwig-Maximilian University, School of Medicine, Nussbaumstraןe 7, D-80336 Munich, Germany ([email protected]).