Title

Accuracy of primary care medical providers' understanding of the FDA black box warning label for antidepressants

Abstract

Purpose: To explore the accuracy of primary care providers' understanding of the FDA black box warning label for SSRI antidepressants for children and adolescents. Methods: A total of 115 licensed primary care providers (PCPs) completed an email survey addressing the FDA black box warning label. Results: Despite self-reports of being well informed about the black box warning label, over 91% of PCPs incorrectly reported that the warning label states that patients died by suicide in the aggregated SSRI clinical trials for children and adolescents, in contrast to the actual reported risk for increased frequency of suicidal thinking and suicide-related behaviors (i.e. suicide attempts and deliberate self-harm). The majority of PCPs (90%) also reported providing verbal information to patients regarding the nature of risk. Conclusions: Efforts need to be made to improve PCPs' understanding of the risk communicated in the FDA black box warning label for children and adolescents, specifically that increased risk does not include risk for death by suicide. © 2008 Informa UK Ltd.

Publication Title

Primary Care and Community Psychiatry

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