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

J. Magno Zito, D. J. Safer, Satish Valluri

Research output: Chapter in Book/Report/Conference proceedingChapter

Abstract

The sharply differing perspectives of the various stakeholders on the benefit-to-risk assessment of selective serotonin reuptake inhibitors (SSRIs) have generated much confusion. To make these issues clearer, this chapter aims to provide a review and critique of the following topics: (1) published randomized pediatric clinical trials on the efficacy of SSRIs for the treatment of major depressive disorder; (2) meta-analysis of related published and unpublished trials; (3) safety of SSRIs from clinical trial analyses and published clinical trial reports; (4) safety of SSRIs from observational studies; (5) suggestions for new studies to assess suicide-related events and associated treatment-emergent adverse drug events (e.g., hostility, aggression, and activation); (6) improving the safety infrastructure to assess drug safety in children and adolescents; and (7) consequences of US Food and Drug Administration boxed warnings. From this updated review, the reader should have a more detailed knowledge base from which to assess clinical and regulatory decisions related to the safety and efficacy of the SSRIs for the treatment of depression in youth to aid future outcomes research and policy.

Original languageEnglish (US)
Title of host publicationMann's Pharmacovigilance
Subtitle of host publicationThird Edition
PublisherWiley-Blackwell
Pages717-734
Number of pages18
ISBN (Electronic)9781118820186
ISBN (Print)9780470671047
DOIs
StatePublished - Jun 23 2014

Keywords

  • Antidepressants
  • Children and adolescents
  • Clinical trials
  • Drug safety
  • FDA
  • FDA warning
  • Major depressive disorder
  • Meta-analysis
  • Selective serotonin reuptake inhibitors
  • Suicidal ideation and behavior

ASJC Scopus subject areas

  • Medicine(all)

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