Risk of adverse behavioral effects with pediatric use of antidepressants
- Wayne K. GoodmanAffiliated withDepartment of Psychiatry, University of Florida College of Medicine, McKnight Brain Institute Email author
- , Tanya K. MurphyAffiliated withDepartment of Psychiatry, University of Florida College of Medicine, McKnight Brain Institute
- , Eric A. StorchAffiliated withDepartment of Psychiatry, University of Florida College of Medicine, McKnight Brain Institute
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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.
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.
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.
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.
KeywordsChildren Adolescents Antidepressants SSRIs Fluoxetine Obsessive compulsive disorder OCD Depression Activation syndrome Suicide Suicidality Black box FDA
- Risk of adverse behavioral effects with pediatric use of antidepressants
Volume 191, Issue 1 , pp 87-96
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- Obsessive compulsive disorder
- Activation syndrome
- Black box
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