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Antidepressant/Child Suicide Risk Slim

Study: Depression Drugs' Benefits for Kids Far Outweigh Suicide Risk
By
WebMD Health News
Reviewed by Louise Chang, MD

April 17, 2007 -- Antidepressants may slightly increase children's risk of suicide, but the drugs' benefits far outweigh this risk, a new look at the evidence suggests.

To give prescription antidepressants to your child or teen, you have to get past the FDA's scary black-box warning on the label.

"In clinical studies, antidepressants increased the risk of suicidal thinking and behavior in children and adolescents with depression and other psychiatric disorders," the label states.

Pediatric antidepressant use has dropped since the labels appeared in 2004. But the child and teen suicide rate has gone up, not down. Why?

A new analysis of clinical-trial data suggests an answer: The FDA may have overestimated the risks -- and underestimated the benefits -- of antidepressant drugs for children. The study comes from University of Pittsburgh researcher David A. Brent, MD, and colleagues.

"These medications appear to be safe and effective for anxiety, obsessive-compulsive disorder (OCD), and depression," Brent tells WebMD. "The number of people likely to be helped is much larger than the number likely to develop some suicidal response to treatment. In our opinion, the risk/benefit ratio is favorable."

The findings appear in the April 18 issue of The Journal of the American Medical Association.

Antidepressant Benefit vs. Suicide Risk

Brent, Ohio State University researcher Jeffrey A. Bridge, PhD, and colleagues analyzed all available data from pediatric clinical trials of so-called "second-generation" antidepressants. These include Effexor, Remeron, and selective serotonin reuptake inhibitors (SSRIs) such as Prozac.

All children and teens in the studies suffered from major depression, OCD, or a non-OCD anxiety disorder.

"In all of the three indications, more people benefit from the medication than benefit from placebo," Brent says. "We saw the strongest effect in anxiety, about a 37% difference in response rate. In OCD, we saw about a 20% difference, in the moderate range. For depression the effect was more modest, about 11%."

Brent stresses that the trials were designed only to see whether the drugs had an effect. They were not designed to see what it takes to return children or teens to mental health.

"Response in these trials meant 'improved or very much improved.' But that is not the same as being completely better," Brent says. "Part of the issue is that these are short trials, eight to 12 weeks, and treatment takes longer. Often people need psychotherapy in addition to medication to recover. So the medication may be necessary rather than sufficient."

In 2004, the FDA presented to its expert advisory panel an analysis of much the same data. Using a different statistical approach, that analysis came to a much different conclusion. It found little evidence that antidepressants helped kids but found a small but significant risk of suicidal thinking. It led to the panel's eventual 18-5 vote to put the black-box warning on the drugs' labels.

Robert Gibbons, PhD, professor of psychiatry and director of the Center for Health Statistics at the University of Illinois at Chicago, was one of the five panel members who voted against the black-box warning.

"The FDA presentation showed very little benefit -- so most panel members said, 'Why tolerate even the slightest risk?'" Gibbons tells WebMD.

"The Brent study is showing that the FDA overestimated the effect of antidepressant medications on suicidality and dramatically underestimated the efficacy of antidepressants in the treatment of childhood depression," Gibbons says.

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