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The twofold increase in risk for suicidal behaviors (but not completed suicide) recently found among children and adolescents taking SSRIs has fostered continuing concern about prescribing antidepressants to young patients. Two new reports rebalance the debate.
Investigators conducted a meta-analysis of 27 pediatric, randomized, placebo-controlled, efficacy studies, 7 of which were not included in the original FDA analysis of suicide risks. Treatment indications were major depressive disorder (MDD; 15 studies); obsessive-compulsive disorder (6 studies), and non-OCD anxiety disorders (6 studies). Antidepressants were mostly SSRIs (also, nefazodone, venlafaxine, and mirtazapine). Differences in therapeutic response between drug and placebo were 11%, 20%, and 37% for MDD, OCD, and anxiety disorders; for one patient to benefit, 10, 6, and 3 patients, respectively, would need to be treated. The differences in risks for suicidal behavior between drug and placebo for the three disorders were 1.0%, 0.5%, and 0.7%; on average, for one patient to be harmed, 143 patients would need to be treated. There were no suicides. In MDD studies, drug response was lower in younger children, in patients with longer episodes, and in studies with more sites.
Other researchers examined prescription trends after the FDA’s public health advisory in October 2003 and black-box warning in September 2004. Researchers tracked prescriptions in a large retail pharmacy prescription database between June 2000 and March 2005 (>1.4 billion prescriptions annually). Prescriptions for those under 18, but not for adults, decreased by 5% and 11% in the first two quarters of 2004 before leveling off.
Bridge JA et al. Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: A meta-analysis of randomized controlled trials. JAMA 2007 Apr 18; 297:1683-96.
Nemeroff CB et al. Impact of publicity concerning pediatric suicidality data on physician practice patterns in the United States. Arch Gen Psychiatry 2007 Apr; 64:466-72.
Comment
These data can help place in perspective previous reports on risks of antidepressants in pediatric patients. The meta-analysis confirms once again that antidepressants increase risk for suicidal behavior, although the calculated risk is somewhat smaller than elsewhere because its statistical techniques recognize study heterogeneity. The results also suggest that antidepressants are effective in children and adolescents, most strongly for non-OCD anxiety disorders and least so for depression. The gap between the numbers needed to treat and to harm is large.
The other study suggests that fewer pediatric patients are receiving antidepressants since the FDA’s advisory. Still, as the authors of the meta-analysis note, the risk-benefit ratio suggests that antidepressants, including SSRIs, should be considered as one of several first-line treatment options, provided that clinicians carefully select and monitor the patients.