Evaluation of suicidal thoughts and behaviors in children and adolescents taking paroxetine.
OBJECTIVE
The aim of this study was to summarize results of a blinded review of potential suicidal events and analyses comparing incidence rates between paroxetine- and placebo-treated pediatric patients.


METHODS
One thousand one hundred ninety-one (1191) children and adolescents received paroxetine (n = 642) or placebo (n = 549) during placebo-controlled portions of all acute double-blind trials of paroxetine (n = 5). An expert panel blindly reviewed and categorized all identified cases detected by electronic and manual search of adverse events (AEs), serious AEs, and selected cases as suicidal or non-suicidal behavior. Incidence rates were calculated for suicide-related events and for rating scale items assessing suicidality.


RESULTS
Suicide-related events occurred more often in paroxetine (22 of 642, 3.4%) than placebo groups (5 of 549, 0.9%); odds ratio (OR) 3.86 (95% CI 1.45, 10.26; p = 0.003). All suicide-related events occurred in adolescents of at least 12 years, except for 1 of 156 paroxetine-treated children. All suicide attempts occurred in major depressive disorder (MDD); few suicide-related events occurred in patients with a primary anxiety disorder. Suicide item analyses did not reveal significant differences between paroxetine and placebo.


CONCLUSIONS
Adolescents treated with paroxetine showed an increased risk of suicide-related events. Suicidality rating scales did not show this risk difference. The presence of uncontrolled suicide risk factors, the relatively low incidence of these events, and their predominance in adolescents with MDD make it difficult to identify a single cause for suicidality in these pediatric patients.
Apter
Alan
A
Schneiders Childrens Medical Center of Israel, Sackler School of Medicine, Petah Tikva, Israel. eapter@clalit.org.il
Lipschitz
Alan
A
Fong
Regan
R
Carpenter
David J
DJ
Krulewicz
Stan
S
Davies
John T
JT
Wilkinson
Christel
C
Perera
Philip
P
Metz
Alan
A
D000293:Adolescent; D002648:Child; D006801:Humans; D001523:Mental Disorders / Q000188:drug therapy / Q000453:epidemiology* / Q000523:psychology; D017374:Paroxetine / Q000009:adverse effects*; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D013405:Suicide / Q000523:psychology; D013406:Suicide, Attempted / Q000523:psychology
D017374:Paroxetine