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.


METHODS
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).


CONCLUSIONS
Despite the methodological limitations of this study, the large AMSP data set supports the assumption that antidepressant drugs rarely trigger suicidality.
Stübner
Susanne
S
Department of Psychiatry, Ludwig-Maximilian University, School of Medicine, Nussbaumstraße 7, D-80336 Munich, Germany. susanne.stuebner@med.uni-muenchen.de
Grohmann
Renate
R
von Stralendorff
Irmela
I
Rüther
Eckart
E
Möller
Hans-Jürgen
HJ
Müller-Oerlinghausen
Bruno
B
Engel
Rolf R
RR
Horvath
Andreas
A
Greil
Waldemar
W
D000293:Adolescent; D018759:Adrenergic Uptake Inhibitors / Q000009:adverse effects; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data*; D000368:Aged; D000369:Aged, 80 and over; D000928:Antidepressive Agents / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008996:Monoamine Oxidase Inhibitors / Q000009:adverse effects; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects; D059020:Suicidal Ideation; D013405:Suicide / Q000523:psychology*
D018759:Adrenergic Uptake Inhibitors; D000928:Antidepressive Agents; D008996:Monoamine Oxidase Inhibitors; D017367:Selective Serotonin Reuptake Inhibitors