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

Health Affairs October 1, 2024
Stephen B. Soumerai, Ross Koppel, Huseyin Naci, Jeanne M. Madden, Andra Fry, Alyssa Halbisen, Jesenia Angeles, Jonah Koppel, Rachelle Rubin, Christine Y. Lu

Abstract

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...

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