Suicides Increasing Following FDA’s Boxed Warning Implementation on Antidepressants


There was also a decline depression care in recent years among adolescents and young adults.

Christine Y. Lu, PhD, MSc

While the US Food and Drug Administration (FDA) regularly issues boxed warnings on antidepressants for the risk of suicide, they might be influencing suicide trends among adolescents and young adults.

A team, led by Christine Y. Lu, PhD, MSc, Harvard Medical School Department of Population Medicine and Harvard Pilgrim Health Care Institute, examined whether suicide deaths increased following FDA warnings and declined in depression care using 28 years of nationwide death certificate data.

In 2003, the FDA issued a public health advisory that children and adolescents taking antidepressants were at an increased risk of suicidal ideation and behavior. The FDA then issued a more serious “boxed warning” of the risk to be included in all antidepressant drug labeling in 2005.

In the past, research has shown decreased depression diagnosis, psychotherapy, and medications and increased suicide attempts following the FDA’s antidepressant warning on suicidality risk among younger individuals. These effects on care have spilled over to older adults suffering from psychiatric disorders.

The investigators conducted an interrupted time series study of validated death data between 1990-2017 to estimate changes in trends of US suicide deaths per 100,000 adolescent individuals between 10-19 and young adults between 20-24 years old following warnings. They also controlled for baseline trends.

Prior to the FDA warnings (1990-2002), suicide deaths decreased substantially. However, following the warnings (2005-2017), with abrupt decline in treatments, suicide deaths increased markedly.

The investigators also found an immediate increase of 0.49 suicides per 100,000 adolescent (95% CI, 0.12-0.86), with a trend increase of 0.03 suicides per 100,000 adolescents per year (95% CI, 0.026-0.031).

The research team also discovered 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). Assuming baseline trends continued, there could have been as many as 5958 excess suicides nationally by 2010 among yearly cohorts of 43 million adolescents and 21 million young adults.

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

Currently, depression is the leading cause of suicide in young people, while suicides among adolescents increasing by more than 50% between 2003-2017.

More than 60% of adolescents do not have a single mental health encounter with either lay counselors or mental health clinicians in the year when they experience a major depressive episode and do not receive first-line evidence-based treatments, such as psychotherapies, including cognitive, behavioral, and interpersonal treatment, or when indicated, antidepressant medications.

It has long been known that appropriate treatment can improve health outcomes in this patient population.

The study, “Increases in Suicide Deaths Among Adolescents and Young Adults Following US Food and Drug Administration Antidepressant Boxed Warnings and Declines in Depression Care,” was published online in Psychiatric Research and Clinical Practice.

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