Are FDA Antidepressant Warnings Linked to Rise in Youth Suicides?

The warnings issued by the Food and Drug Administration (FDA) about the increased risk of suicidality (suicidal ideation and behavior) in young people taking antidepressants may have led to unintended consequences, reported a study published June 18 in BMJ.

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From 2003 to 2007, the FDA issued several health advisories and a black-box warning that children, adolescents, and young adults taking antidepressants were at increased risk for suicidal behavior—leading to intense media attention. Some experts have since attributed the steep decline in the number of antidepressant prescriptions to youth to these FDA warnings.

“These drugs can save lives,” stated the study’s senior author Stephen Soumerai, Sc.D., a professor of population medicine at Harvard Pilgrim Health Care Institute, but in reporting about the FDA antidepressant warning, “The media concentrated more on the relatively small risk than on the significant upside,” he said.

The risk of suicidality cited by the FDA was approximately 1 percent for youth treated with antidepressants. A 2007 study published in the American Journal of Psychiatry reported that the use of antidepressants by youth and young adults dropped quickly by 20 percent, without a reciprocal increase in treatment alternatives such as psychotherapy or atypical antipsychotics (Psychiatric News, June 15, 2007). These findings prompted Soumerai and colleagues to investigate whether a link exists between the FDA warnings about antidepressants and a gradual increase in suicidality among youth in the years after the warning.

To assess whether such a correlation exists, the researchers collected data from 2000 to 2010 on 7.5 million patients aged 10 to 64. Patients were assessed on changes in antidepressant use, suicide attempts, and deaths by suicide before and after the FDA’s highly publicized black-box warning was issued in 2004.

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

“Our study provides the first evidence that suicide attempts increased rather than decreased after the warnings,” noted the authors. “[The] data are consistent with the Centers for Disease Control and Prevention report that showed gradual increases in completed suicides between 1999 and 2010 . . . among people aged 10 to 34 years.”

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 interpretation of the current findings should be taken with caution. “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, 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.

The current study was funded by the National Institute of Mental Health. ■