A new systematic review led by the Harvard Pilgrim Health Care Institute highlights how FDA Black-Box Warnings on youth antidepressants have inadvertently worsened pediatric mental health outcomes, leading to reduced medication use and increased suicides.
A troubling new study suggests that FDA warnings about the potential dangers of antidepressants for young people may have unexpectedly exacerbated the mental health crisis they were meant to address. A systematic review led by the Harvard Pilgrim Health Care Institute found that these warnings significantly reduced essential medication use and mental health treatment for pediatric depression, subsequently increasing suicide attempts and deaths.
The research, published in the October issue of Health Affairs, was a collaborative effort involving experts from the University of Pennsylvania, London School of Economics and Political Science, Northeastern University, Drexel University and The University of Sydney.
Since 2003, the FDA has issued advisories suggesting a possible link between antidepressants and suicidal thoughts and behaviors among youth. In 2005, it escalated these advisories to Black-Box Warnings for those under 18, and in 2007, it extended these warnings to include young adults up to age 24. These warnings intended to heighten vigilance among physicians in monitoring patients for suicidal thoughts and behaviors. Unfortunately, growing evidence shows an unintended reduction in pediatric mental health care followed.
“Our goal was to assess the intended and unintended outcomes of the youth antidepressant warnings by conducting a systematic review of the most credible evidence in the field,” lead author Stephen Soumerai, a Harvard Medical School professor of population medicine at the Harvard Pilgrim Health Care Institute, said in a news release. “We screened all available research reports on the warnings, focusing on those that met rigorous research design criteria and synthesized the most trustworthy data available.”
The review meticulously examined 1,841 research reports published between January 1, 2003 and October 31, 2022. Of these, 34 studies measured the outcomes of the warnings and 11 met the stringent criteria for research design. These selected studies documented significant decreases in depression diagnoses and doctor visits for depression following the FDA advisories. They also noted an increase in suicide-related incidents.
“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,” added Soumerai.
The study revealed that fewer than 5% of pediatric patients were monitored according to FDA’s recommended contact schedule following the warnings. This low rate did not change from before the advisories, and no improvements in mental health care or decreases in suicide attempts were documented.
The research indicates that the Black-Box Warnings may have inadvertently reduced essential mental health care. Four studies encompassing over 12 million patients reported drastic reductions in doctor visits and depression diagnoses. The relative decline in antidepressant treatment and use ranged from 20% to 50% across seven studies.
Compounding the issue, three studies highlighted increases in psychotropic drug poisonings — used as a proxy for suicide attempts — and suicide deaths among pediatric patients. Although young adults from 18 to 24 were not directly included, the ramifications of these warnings have also negatively affected this age group, contributing to a decline in mental health care and uptick in suicides.
“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,” Soumerai added.