Science & Technology: Antidepressants Safe for Children

Issue Date: 
April 29, 2007

Antidepressants are safe and effective for treating anxiety, obsessive-compulsive disorder (OCD), and major depressive disorder in children and adolescents, according to a meta-analysis of 27 major studies. The findings, published recently by Pitt School of Medicine researchers in the Journal of the American Medical Association (JAMA), call into question the controversial “black box” warnings placed on the drugs by the U.S. Food and Drug Administration (FDA); the warnings state that antidepressant medications pose a small but significantly increased risk of suicidal thoughts and behavior for children and adolescents.

“As clinicians, our first concern is for the health and safety of our patients,” said Pitt Professor of Psychiatry David A. Brent. “When the FDA placed the ‘black box’ warning on antidepressants, it raised a great deal of concern about how we were to treat our young patients who we thought could possibly benefit from antidepressant therapy. Most clinicians, patients, and their families found themselves questioning whether or not they should be using treatments out of fear of the risks. By combining data from most of the significant studies of antidepressant use in adolescents and children, we’ve been able to examine a balance of benefits and risks of these medications.

“Antidepressants are safe and effective for treating disorders like anxiety, OCD, and depression in children and adolescents,” Brent added. “While there is a small, increased risk of suicidal thoughts in those who use antidepressants, it would be much, much riskier to not treat these children and adolescents dealing with these disorders.”

For the study, Pitt researchers extracted data on study characteristics, efficacy outcomes, and emergent suicidal events from 27 trials of second-generation antidepressants used to treat pediatric major depressive disorder, OCD, and anxiety in children and adolescents under the age of 19.

Researchers found that one in 100 participants in the studies included in the meta-analysis had new-onset suicidal ideation, or suicidal thoughts, while on medication. Even fewer acted on these thoughts, and there were no completed suicides.

The results showed that antidepressants were most effective in treating anxiety, moderately effective for treating OCD, and modestly effective for depression.

“While I support the FDA’s role in monitoring the safety of medications, in this case, the FDA should reconsider the ‘black box’ warning on these medications,” said Brent. “Our study supports the cautious and well-monitored use of antidepressant medications as a first-line treatment for anxiety, OCD, and depression.”

The Pitt study was funded by the National Institute of Mental Health, one of the National Institutes of Health.