The study described below documents the tragic effect caused by the medical establishment's - especially psychiatrists' - continued ignorance and avoidance of the traumatic effects of childhood abuse and neglect. The FDA adopted policies based on an ignorant understanding of adolescent depression, suicidality, suicides and antidepressant prescriptions. The lack of recognition of child abuse and neglect as the underlying cause of distress (and resultant treatment) in many patients led to a confused and mistaken interpretation of cause and effect, resulting in significant patient harms.
Adapted from Medscape Medical News, October 7, 2024 referencing October, 2024 article in HEALTH AFFAIRS
In October 2003, the FDA warned that antidepressants may be associated with suicidality among people younger than age 18 years soon after starting treatment. In January 2005, the FDA required a permanent black box warning of this risk on product labels and in television and print advertising for all antidepressant drugs. In May 2007, the FDA expanded the 2005 black box warning to include young adults through age 24, and this broader warning remains in effect today.
These black box warnings added to antidepressant medications on increased risk for suicidality were associated with a decline in mental health treatment and an increase in suicide attempts and deaths in young people. Investigators said the totality of evidence supports "reevaluation and possible replacement" of the US Food and Drug Administration (FDA) black box warning with routine warnings in product labeling.
"The sudden, simultaneous, and sweeping effects of these warnings â the reduction in depression treatment and increase in suicide â 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," lead author Stephen Soumerai, ScD, professor of population medicine, Harvard Medical School at Harvard Pilgrim Health Care Institute, Boston, said.
Through an exhaustive literature search, the researchers identified 34 studies of depression and suicide-related outcomes published in peer-reviewed journals after the warnings were issued. Eleven of these studies measured abrupt changes in outcome trends following the warnings and were included in their analyses. Four studies, with more than 12 million patients, found "consistent evidence of sudden and substantial" long-term declines in doctor visits for depression and depression diagnoses after the FDA warnings, the study team noted.
These studies showed increases in physician visits for depression and depression diagnoses in the years before the warnings and abrupt, sustained declines, ranging from 20% to 45%, in visits and diagnoses after the warnings. "Some spillover occurred in comparison groups of adults, who were not targeted by the FDA warnings," the study team said.
Seven studies revealed evidence that the FDA warnings were followed by abrupt reductions in antidepressant treatment and use, ranging from 20% to 50%. Most of these studies showed increasing use of antidepressants in the years before the FDA warnings, followed by abrupt and sustained reductions in use afterward.
Three studies found evidence of declining or flat trends in psychotropic drug poisonings and suicide deaths among pediatric patients before the warnings, followed by abrupt increases in these trends after the warnings were issued.
No study documented improvements in mental health care or declines in suicide attempts or suicides after the warnings went into effect.
"The overwhelming evidence suggests that the ongoing use of these warnings may result in more harms than benefits," the authors wrote.
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