Study: Increased Suicide Deaths, Decreased Depression Care Following FDA Antidepressant Boxed Warnings
A recent study shows an unintended increase from 20% to 60% in the proportion of depressed youth without antidepressant treatment.
Investigators have found decreased depression diagnosis, psychotherapy, and medications as well as increased suicide attempts following the FDA’s implementation of antidepressant boxed warnings regarding youth suicidality risk.
In the study, researchers conducted an interrupted time series study of validated death data between 1990 and 2017 in order to estimate the changes in trends of suicide deaths per 100,000 adolescents and young adults. They found that before the warnings, between 1990 and 2002, suicide deaths decreased substantially, though they increased markedly after the warnings were implemented.
According to the findings, there was an immediate increase of 0.49 suicide deaths per 100,000 adolescents and a trend increase of 0.03 suicides per 100,000 adolescents per year. They also saw an immediate increase of 2.07 suicides per 100,000 young adults and a trend increase of 0.05 suicides per 100,000 young adults. Assuming that baseline trends continued, the authors concluded that there may have been 5958 excess suicides nationally by 2010 among adolescents and young adults.
Previous research had found a decline in depression care following the implementation of the warnings, which were based on a controversial analysis of industry drug trials. Depression is the leading cause of suicide among youth, and suicide among adolescents have increased by more than 50% between 2003 and 2017, according to the study. More than 60% of adolescents do not have a single mental health encounter during the year when they experience a major depressive episode, although appropriate treatment can improve health outcomes among this population, the authors noted.
Although the authors said randomized trials are not feasible to examine the effects of boxed warnings, several time-series studies found sudden, large declines in identification of depression among adolescents, young adults, and adults up to age 89 among 55 million enrollees in US health plans. Notably, the FDA warnings were not intended to reduce drug and nondrug treatment, but rather to increase monitoring for suicidal thoughts and behavior during therapy.
Perhaps most notably, the authors found an unintended increase from 20% to 60% in the proportion of depressed youth without antidepressant treatment. Several earlier studies found 30% to 50% declines in the use of antidepressants among teens and young adults, including spillover effects to older adults not targeted by the warnings.
Based on their findings, the authors concluded that the FDA should err on the side of caution with regard to drug warnings. Specifically, they said the FDA should consider replacing the boxed warning with less severe language that still communicates information on risks without endangering essential, first-line treatments of depression in youth.
Lu CY, Penfold RB, Wallace J, Lupton C, et al. Increases in Suicide Deaths Among Adolescents and Youth Adults Following US Food and Drug Adminstration Antidepressant Boxed Warnings and Declines in Depression Care. Psychiatric Research and Clinical Practice; October 7, 2020. https://onlinelibrary.wiley.com/doi/full/10.1176/appi.prcp.20200012. Accessed October 12, 2020.