Antidepressant Warnings: A Decade of Controversy

For nearly two decades, a black box warning on antidepressants has declared a potential increased risk of suicidal thoughts and behaviors in young people. Paradoxically, evidence suggests this very warning might have led to fewer depression diagnoses, reduced prescriptions, and, ultimately, higher suicide rates.

The Unintended Consequences of Warnings

Mounting evidence points to the negative unintended consequences of these warnings. Clinicians and researchers are urging the US Food and Drug Administration (FDA) to review and potentially revise or even eliminate the black box warnings.

A sobering report published in October 2023 in Health Affairs reviewed studies conducted between 2003 and 2022. It revealed a 20%-40% decline in physician visits for depression, a 20%-50% decline in antidepressant use, and a concerning increase in psychotropic drug poisonings and suicides—all occurring after the warnings were implemented.

“FDA officials should review the totality of evidence and err on the side of caution in acknowledging possible harms of the antidepressant warnings,” wrote lead author Stephen Soumerai, ScD, professor of population medicine at Harvard Medical School at Harvard Pilgrim Health Care Institute, Boston, and colleagues. They called on the FDA to replace the boxed warnings with a routine warning in labeling.

Evolving Evidence and Growing Concerns

While there was limited data on the risks and benefits of antidepressants in youth when the black box warnings were initially introduced in 2005, more evidence has emerged since then. Jeffrey Strawn, MD, professor of psychiatry and pediatrics at the University of Cincinnati College of Medicine, believes this new information calls for a reevaluation by the FDA.

“I don’t think that they’ve been useful. They’ve actually been harmful