REVIEW OF: Soumerai SB et al, Health Aff (Millwood) 2024;43(10):1360–1369

STUDY TYPE: Systematic review of quasi-experimental studies

We continue to track the fallout from the FDA’s 2004 black box warning on antidepressant-related suicidality in youth. Early research found a drop in prescribing alongside a rise in suicides, though rates of new suicidal thinking with SSRIs later settled near 1%, reinforcing the need for close monitoring. This systematic review, spanning 2003 to 2022, asks whether monitoring and suicide-related outcomes improved in youth on SSRIs. The findings are unsettling.

The review pooled quasi-experimental studies, using drug-poisoning rates as a stand-in for suicide attempts. Only one study tracked all three outcomes that matter clinically: suicidality monitoring, depression-related visits, and psychotherapy visits.

Despite the warning, clinician monitoring for suicidality never rose meaningfully, staying below 5%. What changed instead was treatment. Depression diagnoses and visits fell 20%–45%, antidepressant prescribing fell 20%–50%, and psychotherapy didn’t fill the gap; in some studies, it declined too.

CARLAT TAKE

Though this study shows association rather than causation, suicide-related outcomes have worsened since the black box warning. Drug poisonings rose substantially among adolescents and young adults, and earlier declines in suicide deaths were reversed, with some estimates suggesting thousands of excess deaths (however, it’s possible that other factors played a role, like rising social media use). Rather than boost safety monitoring, the warning may have simply scared clinicians and families away from treating depression at all.

Antidepressant effect sizes in youth are modest, and the suicidality risk is real but small—far smaller than the risk of untreated depression. Don’t let the black box deter you. Counsel patients and families up front on the small risk of suicidality, and keep screening for it during follow-up visits.