Systematic Review Shows FDA Antidepressant Warnings Linked to Mental Health Care Decline and Rising Suicide Rates in Youth
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The longstanding epidemic of severe pediatric depression is a significant public health concern, with only one third of the affected population receiving any mental health care. A new systematic review suggests that FDA-issued warnings about antidepressant use, intended to increase monitoring of suicidal thoughts among youth, have led instead to unintentional harm.
The study was led by the Harvard Pilgrim Health Care Institute with collaborators from the University of Pennsylvania, London School of Economics and Political Science, Northeastern University, Drexel University, and The University of Sydney.
The findings are published in the October issue of Health Affairs.
Since 2003, the FDA has advised that antidepressants might be linked to suicidal thoughts and behaviors in young people. These warnings, upgraded to a Black-Box Warning (the most serious level of warning) in 2005 for those under 18 and an expansion in 2007 to include young adults up to the age of 24, were intended to encourage physician vigilance in monitoring patients for suicidal thoughts and behaviors. However, experts say evidence shows they resulted in a decline in pediatric mental health.
Because it is unlikely that any one outside factor can account for the multiple sudden and parallel effects on depression care, suicidal behavior, and deaths by suicide, the authors suggest that allowing the warnings to stand may contribute to the continuing pediatric mental health crisis.
“The sudden, simultaneous, and sweeping effects of these warnings––the reduction in depression treatment and increase in suicide––are documented across 14 years of strong research. The consistency in observed harms and absence of observed benefits after the Black-Box Warnings indicate this is not a coincidence,” adds Dr. Soumerai, Harvard Medical School professor of population medicine at the Harvard Pilgrim Health Care Institute “We recommend that the FDA consider incorporating the Black-Box Warnings into the list of routine warnings that pose fewer health risks, or potentially removing the warnings altogether.”
Reference: 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 2024 43
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