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Do Antidepressants Increase Suicidality in Younger Patients?

How the FDA developed its warnings

In 2004, the FDA concluded that children and adolescents taking antidepressants had elevated risks for suicidal thoughts or attempts. This report from the FDA’s Center for Drug Evaluation and Research describes the data underlying the FDA impression.

Data were extracted from 24 placebo-controlled pediatric trials of five SSRIs, bupropion, venlafaxine, nefazodone, and mirtazapine (4582 subjects; duration, 4–16 weeks). Sixteen studies examined depression treatment; the others were for obsessive-compulsive, generalized-anxiety, and social-anxiety disorders, and for ADHD. Except for one NIMH-funded trial, all studies were manufacturer-sponsored.

No suicides occurred. Suicidality -- defined as new or increased suicidal thoughts, preparations for attempts, or attempts -- was measured through spontaneously reported adverse events and a single suicide item on the various primary depression-rating scales employed in 17 studies. The incidence of suicidality ranged from 0% to 8%, with 89 subjects showing suicidality; possible suicidality was suggested in 120 others. Only the NIMH-sponsored trial had a significantly increased excess of suicidality associated with antidepressant use, although in eight trials, the relative risk for suicidality with antidepressants was nonsignificantly elevated (RR, 2). The pooled relative risk for suicidality with antidepressants was 1.95 for all patients and 1.66 for patients in depression trials.

Comment: The authors and commentators advise that these results be interpreted cautiously. Suicide risk was not the primary outcome of the studies; general adverse-events logs were used; design and duration varied across the studies, which generally were too short to evaluate clinical risks; and multiple statistical tests were performed. Possible differences in dropout rates between placebo recipients and antidepressant recipients could have created differences in risks. Also, some cases of early-onset depression are bipolar, which is associated both with an elevated incidence of suicidality and with antidepressant-exacerbated agitation and impulsivity.

The absence of suicide in this small sample is not entirely reassuring. It seems like clinical common sense to carefully evaluate and follow children who take antidepressants, just as it is common sense to conclude that competent clinicians should continue to prescribe antidepressants, especially since observational studies show that depressed patients attempt suicide more commonly before initiating antidepressants than after beginning them (Journal Watch Psychiatry Feb 22 2006).

— Steven Dubovsky, MD

Published in Journal Watch Psychiatry April 19, 2006

Citation(s):

Hammad TA et al. Suicidality in pediatric patients treated with antidepressant drugs. Arch Gen Psychiatry 2006 Mar; 63:332-9.

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• Medline abstract (Free)

Baldessarini RJ et al. Suicidal risk in antidepressant drug trials. Arch Gen Psychiatry 2006 Mar; 63:246-8.

• Original article (Subscription may be required)
• Medline abstract (Free)