In Kids, Benefits of Antidepressants Appear to Outweigh Risks
Parents of clinically depressed children often find themselves in a troubling quandary, forced to weigh the mood-lifting benefits of antidepressants against the small but very real risk of suicidal behavior that may occur in young people who take these drugs. The Food and Drug Administration requires a black box warning on antidepressants (including Prozac, Paxil, and Zoloft) concerning the possibility of suicidal thoughts, attempts, and behaviors in anyone under 25 who takes the drugs. But a new study, published in this week's Journal of the American Medical Association, indicates that the drugs' benefits outweigh the risks.
Researchers examined 27 clinical trials of antidepressants in kids, involving a total of 5,300 children and teens diagnosed with depression or anxiety. Their conclusion: 61 percent of depressed children on antidepressants felt better, compared with 50 percent of the children who took a placebo; 52 percent of those with obsessive-compulsive disorder benefited from the drugs, compared with 32 percent of those on placebos. It did turn out to be true that the kids taking medication also had a higher incidence of suicidal thoughts, but the difference was very small. Three percent of depressed youngsters using the drugs had suicidal tendencies, compared with 2 percent of those on placebos; the gap for those being treated for obsessive-compulsive disorders was about 1 percent versus 0.5 percent. "We tried to put the risks in the context of the benefits, and clearly many more children received a clinical benefit than developed suicidal ideation," says study coauthor David Brent, a professor of psychiatry at the University of Pittsburgh School of Medicine.
The findings come with some important caveats: Most of the trials analyzed excluded teens and children who were determined beforehand to be at increased risk of suicide. What's more, the study found that for children under 13, Prozac was the only drug that offered greater clinical benefits than the placebos. "The JAMA article does not change FDA's views about the suicidality risk or, indeed, about the effectiveness of these drugs in children with depression," says Thomas Laughren, FDA director of the psychiatry products division in an E-mailed statement. "At this time nothing indicates a need for change in the black box warning."
But statistics suggest otherwise. According to a February report from the Centers for Disease Control and Prevention, suicides in children, which had been declining, rose by 18 percent from 2003 to 2004. The FDA held its first public hearings to warn about antidepressant risks in children in 2003 and added the black box in 2004. Since that time, prescriptions written for antidepressants in children have declined by 20 percent. "I think the warning needs to be reconsidered," says Brent, "something that's not so scary might be more appropriate."