Did FDA Antidepressant Suicide Warnings Backfire?

Megan Brooks

June 20, 2014

Warnings from the US Food and Drug Administration (FDA) stating that the use of antidepressants among young people may increase the risk for suicidality may have backfired.

A new study shows a small increase in psychotropic drug poisonings, a validated measure of suicide attempts, among adolescents and young adults in the years following the warnings.

The safety warnings were covered widely in the media and led to a decrease in antidepressant use by young people, but at the same time, there was an increase in suicide attempts, Christine Y. Lu, PhD, of the Department of Population Medicine, Harvard Medical School in Boston, Massachusetts, and colleagues found.

"It is essential to monitor and reduce possible unintended consequences of FDA warnings and media reporting," the researchers conclude in a report published online June 18 in BMJ.

Between 2003 and 2004, the FDA issued several health advisories warning that children and adolescents taking antidepressants were at increased risk for suicidal thoughts and behavior. In October 2004, they required that a black box warning of this risk be added to labels of all antidepressant drugs. In May 2007, the FDA extended the warnings to include young adults.

In analyzing healthcare claims data from 11 health plans in the US Mental Health Research Network, the researchers found that antidepressant use fell by 31.0% among adolescents, by 24.3% among young adults, and by 14.5% among adults after the warnings were issued.

These reflected absolute reductions of 696, 1216, and 1621 dispensings per 100,000 people among adolescents, young adults, and adults, respectively.

At the same time, report the researchers, there were significant relative increases in psychotropic drug poisonings in adolescents (21.7%; 95% confidence interval [CI], 4.9% to 38.5%) and young adults (33.7%; 95% CI, 26.9% to 40.4%) but not among adults (5.2%; 95% CI, -6.5% to 16.9%).

These reflected absolute increases of 2 and 4 poisonings per 100,000 people among adolescents and young adults, respectively (approximately 77 additional poisonings in the cohort of 2.5 million young people). Completed suicides did not change for any age group.

The researchers say that it is possible that the warnings and extensive media attention led to "unexpected and unintended population level reductions in treatment for depression and subsequent increases in suicide attempts among young people."

"FDA advisories and boxed warnings can be crude and inadequate ways to communicate new and sometimes frightening scientific information to the public. Also, the information may be oversimplified and distorted when communicated in the media," they add.

The researchers say greater efforts are needed to improve risk communications to the public and to health professionals. "Active surveillance should be considered to allow timely detection and prompt actions to reduce unintended consequences of strong warnings," they conclude.

The study was funded by the National Institute of Mental Health. A complete listing of author disclosures is provided in the original article.

BMJ. Published online June 18, 2014. Full text

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