Harvard Pilgrim Health Care Institute–led researchers conducted a new systematic review that examined extensive evidence documenting pediatric mental health outcomes in the period following the FDA black box warning initiation.
The results published in Health Affairs indicated that the warnings—meant to increase monitoring of suicidal thoughts and behaviors—actually had the adverse effects, including the reduction of essential medication use and mental health treatment of pediatric depression and the resulting increase in suicide attempts and deaths.
The authors call for a reevaluation of the black-box warning.
The FDA has advised that antidepressants might be linked to suicidal thoughts and behaviors in young people for more than 2 decades. Cautions, which began in 2003, were upgraded to a black-box warning in 2005 for those aged younger than 18 years, with an expansion in 2007 to include young adults aged up to 24 years. The intention was to encourage physician vigilance in monitoring patients for suicidal thoughts and behaviors.
“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,” explained lead author Stephen Soumerai, Harvard Medical School professor of population medicine at the Harvard Pilgrim Health Care Institute. “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 study team screened 1,841 research reports published about the warnings from January 1, 2003, to October 31, 2022. Of these, 34 measured the outcomes of the warnings, 11 of which met well-recognized research design criteria. The 11 reports included studies measuring abrupt changes in outcome trends following the October 2003 FDA advisory and/or January 2005 black-box warnings, according to the study team.
The review also found that fewer than 5% of pediatric patients were monitored in line with the FDA’s recommended contact schedule recommendations following the advisory. The authors point out that none of the studies documented improvements in mental health care or declines in suicide attempts or suicides after the warnings went into effect.
In fact, four of the studies, which included more than 12 million patients, reported substantial reductions in doctor visits for depression and depression diagnoses. In general, the studies showed increasing use of antidepressants in the years before the FDA advisory, followed by precipitous reductions in use after the warnings.
The researchers advised that seven studies showed the relative reduction in antidepressant treatment and use ranging from 20% to 50%, while three studies showed increases in psychotropic drug poisonings (a proxy for suicide attempts) and suicide deaths among pediatric patients. Young adults aged from18 to 24 years were not included in the studies of younger pediatric patients, but the study suggested the effects of these warnings “spilled over” to young adults.
“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,” Dr. Soumerai added in a press release. “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.”
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