Risk of adverse behavioral effects with pediatric use of antidepressants.
OBJECTIVE
This article reviews evidence that led the Food and Drug Administration to issue a "black box" warning about the risk of "suicidality" (suicidal thoughts and behavior) in children and adolescents during treatment with antidepressants.


RESULTS
Re-analysis of data from randomized clinical trials of antidepressants in the pediatric population revealed a significantly greater overall (all drugs across all indications) risk ratio for drug 1.95 (95% Cl, 1.28-2.98) compared to placebo in this sample of approximately 4,000 subjects.


CONCLUSIONS
The essential message of the "black box" is to remind prescribers and consumers about the importance of monitoring closely for adverse behavioral changes during the initiation of (or changes in) antidepressant therapy. Possible mechanisms that might account for this phenomenon, particularly the so-called activation syndrome, are discussed.


CONCLUSIONS
Empirical studies are needed to identify the precursors of suicidality and to predict which individuals are most susceptible to adverse behavioral side effects of antidepressants.
Goodman
Wayne K
WK
Department of Psychiatry, University of Florida College of Medicine, McKnight Brain Institute, Room L4-100, P.O. Box 100256, Gainesville, FL 32610-0256, USA. wkgood@psychiatry.ufl.edu
Murphy
Tanya K
TK
Storch
Eric A
EA
D000293:Adolescent; D000928:Antidepressive Agents / Q000009:adverse effects*; D001519:Behavior / Q000187:drug effects*; D002648:Child; D006801:Humans; D001523:Mental Disorders / Q000139:chemically induced* / Q000523:psychology; D017410:Practice Guidelines as Topic; D000297:Psychology, Adolescent; D002666:Psychology, Child; D018570:Risk Assessment; D012307:Risk Factors; D013405:Suicide / Q000523:psychology*; D014481:United States; D014486:United States Food and Drug Administration
D000928:Antidepressive Agents