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Intended And Unintended Outcomes After FDA Pediatric Antidepressant Warnings: A Systematic Review
Journal article   Open access   Peer reviewed

Intended And Unintended Outcomes After FDA Pediatric Antidepressant Warnings: A Systematic Review

Stephen B Soumerai, Ross Koppel, Huseyin Naci, Jeanne M Madden, Andra Fry, Alyssa Halbisen, Jesenia Angeles, Jonah Koppel, Rachelle Rubin and Christine Y Lu
Health affairs (Millwood, Va.), v 43(10), pp 1360-1369
Oct 2024
DOI: https://doi.org/10.1377/hlthaff.2023.00263
PMID: 39374452
Featured in Collection :   UN Sustainable Development Goals @ Drexel
url
https://doi.org/10.1377/hlthaff.2023.00263View
Published, Version of Record (VoR) Open

Abstract

Adolescent Antidepressive Agents - adverse effects Antidepressive Agents - therapeutic use Child Depression - drug therapy Drug Labeling Humans Suicidal Ideation Suicide - statistics & numerical data Suicide, Attempted United States Food and Drug Administration Young Adult United States
Since 2003, the Food and Drug Administration (FDA) has warned that antidepressants may be associated with suicidal thoughts and behaviors among youth. An FDA advisory in 2003 and a black-box warning in 2005 focused on children and adolescents younger than age eighteen. The FDA expanded the black-box warning in 2007 to include young adults. Both warnings were intended to increase physician monitoring of suicidal thoughts and behaviors. Our systematic review identified thirty-four studies of depression and suicide-related outcomes after these warnings; eleven of these studies met research design criteria established to reduce biases. The eleven studies examined monitoring for suicidal thoughts and behaviors, physician visits for depression, depression diagnoses, psychotherapy visits, antidepressant treatment and use, and psychotropic drug poisonings (a proxy for suicide attempts) and suicide deaths. We assessed possible spillover to adults not targeted by the warnings. The one study that measured intended physician monitoring of suicidal thoughts and behaviors did not find evidence of an increase. Multiple studies found significant unintended reductions in mental health care after the warnings. After these reductions, there were marked increases in psychotropic drug poisonings and suicide deaths. These findings support reevaluation of risks and benefits of the FDA's black-box antidepressant warnings.

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