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FDA, NIMH Scrutinize Antidepressant-Linked Suicidality

FDA, NIMH Scrutinize Antidepressant-Linked Suicidality

In a meeting this past December, an FDA advisory committee recommended that the "black-box" warning of antidepressant-linked suicidality in children and adolescents should also warn of the risk in young adults. Meanwhile, the NIMH had announced in November its sponsorship of 5 new studies to elucidate this adverse drug effect, particularly focusing on the SSRI antidepressants.

"These new, multi-year projects will clarify the connection between SSRI use and suicidality," said NIMH Director Thomas Insel, MD. "They will help determine why and how SSRIs may trigger suicidal thinking and behavior in some people but not others, and may lead to new tools that will help us screen for those who are most vulnerable."

The Psychopharmacologic Drugs Advisory Committee recommended a warning covering a wider susceptible age range after reviewing a new meta-analysis of adult antidepressant trials. The committee made the recommendation despite hearing testimony that a broader warning could paradoxically increase suicide risk by further discouraging appropriate antidepressant treatment. Christopher Kratochvil, MD, representing the American Academy of Child and Adolescent Psychiatry, was one of several speakers to caution the committee about such an outcome.

There was a decline of about 20% in new pediatric antidepressant prescribing from 1 year before to 1 year after the current black-box warning was issued, according to Kratochvil. "This decline was due in part to physicians who stopped treating depressed patients, as well as referrals to specialists with excessive waiting periods due to a significant workforce shortage," he explained, "leaving many children and adolescents with depression with limited access to care."

Carolyn Robinowitz, MD, president-elect of the American Psychiatric Association, suggested that a "black-box panic" could result and further impede provision of needed care. Paula Clayton, MD, medical director of the American Foundation for Suicide Prevention stated, "not treating depression carries a far greater risk of suicide than any potential adverse effects of these medications."

These concerns notwithstanding, the committee found the FDA data of antidepressant-linked suicidality occurring through young adulthood compelling. "We want to extend the age in the black box and at the same time not discourage treatment," committee member Andrew Leon, MD, commented.

Analyzing trial data
In their meta-analysis of 372 antidepressant trials involving almost 100,000 subjects, FDA staffers Marc Stone, MD, and Lisa Jones, MD, MPH, found a suicidality adverse drug effect, manifested as ideation or behavior, more likely with the SSRI class (odds ratio, 1.23) than the tricyclic antidepressants (odds ratio, 0.8); other drugs fell between the two and were characterized by the analysts as "generally similar."

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