Thursday, June 19, 2014

FDA Warning Against Antidepressants Linked to Increased Suicidality in Youth, Study Finds

A study published yesterday in BMJ suggested that the U.S. Food and Drug Administration's implementation of a black-box warning that children and adolescents taking antidepressants were at increased risk of suicidality (suicidal ideation and behavior) may have had unintended consequences.

Researchers from Harvard Medical School’s Department of Population Medicine and the Harvard Pilgrim Healthcare Institute collected data from 7.5 million patients—aged 10 to 64—to examine changes in antidepressant use, suicide attempts, and deaths by suicide before and after the highly publicized FDA warning was first issued in 2003.

The analysis showed that one year after the implementation of the warning, use of antidepressants dropped 31 percent among adolescents, 24.3 percent among young adults, and 14.5 percent among adults. Simultaneously, there was a 21.7 percent increase in suicide attempts by psychotropic drug poisoning among adolescents, and a 33.7 percent increase for such among young adults. The number of deaths by suicide did not change for any age group.

Mark Olfson, M.D., M.P.H., a professor of psychiatry at Columbia University Medical Center and an expert in mood disorders, told Psychiatric News that "the new findings shed little light on the complex associations between anxiety and depressive disorders, antidepressant treatment, and the risk of self-harm and suicide. The measure of suicide attempts used in this study, psychotropic poisonings (ICD-9 code 969), is only loosely related to suicide attempts. Most suicide attempts in young people do not involve poisoning by psychotropic drugs and most intoxications do not represent suicide attempts."

Because of the recent substantial increase in unintentional poisonings from stimulants, Olfson stated that the increase in psychotropic overdose could be a result of an underlying substance use disorder rather than suicide. “This trend [of psychotropic overuse by youth], which may be driven by complex societal factors, deserves study and clinical attention,” Olfson concluded.

To read other studies investigating the consequences of the FDA warning, see the Psychiatric News article “Analysis Continues of Fallout From FDA's SSRI Warning.” Also see the American Journal of Psychiatry's study, “Early Evidence on the Effects of Regulators’ Suicidality Warnings on SSRI Prescriptions and Suicide in Children and Adolescents.”

(Martin Novak/


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