Abstract

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Chapter: Pharmacovigilance: The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents

The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents


The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents

ABSTRACT

Much confusion has been generated by the sharply differing perspectives of the various stakeholders on the benefit to risk assessment of selective serotonin reuptake inhibitors (SSRIs). To make these issues clearer, this chapter aims to provide a review and critique of the following topics: (1) published random-ized clinical trials on the efficacy of SSRIs for the treatment of major depressive disorder (MDD); (2) meta-analysis of related published and unpublished trials; (3) safety of SSRIs from clinical trial analy-ses and published clinical trial reports; (4) safety of SSRIs from observational studies; (5) suggestions for new studies to assess suicidality and related treatment-emergent adverse drug events, for example hostility, aggression and activation; (6) improving the safety infrastructure to assess drug safety in children and adolescents and (7) recent consequences of Food and Drug Administration (FDA) black box warnings. From this review, the reader should have a more detailed knowledge base from which to assess clinical decisions related to the safety of the SSRIs for the treatment of depression in youth and to build consen-sus on future research and policy.

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