Boston—
Could an effort to protect youth from the risks of suicidal thoughts and behaviors from antidepressant medications have backfired, actually increasing the number of children and adolescents who took their own lives? A new study suggests that might be the case.

The report in Psychiatric Research and Clinical Practice recounts how a public health advisory issued by the FDA in 2003, followed by drug label warnings, cautioned that young people taking antidepressants were at increased risk of suicidal ideation.

Now, Harvard Medical School–led authors point to research indicating that the warnings reduced the diagnosis and treatment of depression among young people and might have also contributed to an increase in suicide deaths in that cohort.

The report suggests that there were 5,958 excess suicides nationally by 2010 among 43 million adolescents and 21 million young adults.

“Our findings suggest the boxed warnings may have contributed to the very thing the FDA was trying to prevent. More than two-thirds of depressed teens do not receive any depression care whatsoever, an issue now further exacerbated by COVID-19. We strongly recommend the FDA reexamine the use of these warnings,” said principal investigator Stephen Soumerai, ScD, of Harvard Medical School and the Harvard Pilgrim Health Care Institute.

The study team conducted an interrupted time series study of validated death data (1990–2017) to estimate changes in trends of suicide deaths per 100,000 adolescents (ages 10–19 years) and young adults (ages 20–24 years) after the warnings, controlling for baseline trends in the U. S.

“Before the warnings (1990–2002), suicide deaths decreased markedly,” researchers determined. “After the warnings (2005–2017) and abrupt declines in treatment, this downward trend reversed. There was an immediate increase of 0.49 suicides per 100,000 adolescents, 95% confidence interval [CI]: 0.12, 0.86) and a trend increase of 0.03 suicides per 100,000 adolescents per year (95% CI: 0.026, 0.031).”

At the same time, the authors point out, an immediate increase of 2.07 suicides per 100,000 young adults (95% CI, 1.04, 3.10) and a trend increase of 0.05 suicides per 100,000 young adults per year (95% CI, 0.04, 0.06) occurred. 

“Assuming baseline trends continued, there may have been 5,958 excess suicides nationally by 2010 among yearly cohorts of 43 million adolescents and 21 million young adults,” according to the researchers.

With increases in suicide deaths among youth following the warnings and declines in depression care, the authors conclude. “Alternative explanations were explored, including substance use, economic recessions, smart phone use, and unintentional injury deaths. 

Additional factors may have contributed to continued increases in youth suicide during the last decade. Combined with previous research on declining treatment, these results call for re-evaluation of the antidepressant warnings.”

Researchers urge the FDA to “err on the side of caution and consider replacing the boxed warning with less severe warnings that still communicate information on possible drug risks without endangering essential, first-line treatments of depression in youth.”

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