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Psychiatry (Edgmont). 2009 Oct;6(10):30-4.

Decreased Use of Antidepressants in Youth After US Food and Drug Administration Black Box Warning.

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1
Dr. Singh is Assistant Professor, Department of Child and Adolescent Psychiatry, University of Toledo Medical Center, Toledo, Ohio.

Abstract

Objective. This study evaluates changes in use of antidepressants in children and adolescents after the US Food and Drug Administration black box warning for increased risk of suicide.Method. A retrospective chart review was completed for children and adolescents (ages 4-17) who were diagnosed with depressive or anxiety disorders in an outpatient clinic and offered a trial of antidepressants between September 2003 and February 2004 (before the black box warning) and between January 2005 and June 2005 (after the black box warning). Statistical analyses were performed with the SPSS version 17 and R package version 2.9.1. Univariate analysis was conducted using the Fisher's Exact test.Results. The odds ratio calculated for the different groups suggests that in all the groups, the proportion of acceptance of antidepressant use was greater before the black box warning as compared to after the black box warning (odds ratio>1). It was also found that upon combining the age groups after the warning and comparing them, based on the diagnoses, there was a greater degree of refusal of antidepressant therapy when a diagnosis of anxiety disorder was made as compared to a diagnosis of depressive disorder (p=0.017).Conclusion. There has been a decrease in the use of antidepressant therapy in children and adolescents following the US Food and Drug Administration black box warning for risk of suicide. A limitation of this study is that reasons for refusal of antidepressent therapy by parents or guardians of children and adolescents were not collected; therefore, there is no certainty that the black box warning was the primary reason for refusal.

KEYWORDS:

FDA; US Food and Drug Administration; adolescent; antidepressant; anxiety; black box warning; child; depression,; suicidality

PMID:
20011576
PMCID:
PMC2790401
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