Wednesday, April 18, 2007

Scales Said to Tip in Favor of Antidepressant Use in Children

NEW YORK TIMES

CHICAGO, April 17 (AP) — The authors of a comprehensive new analysis say the benefits of antidepressants in children and teenagers trump a small risk that they will experience increased suicidal thoughts and behavior.

The risk found by the researchers is lower than one that the Food and Drug Administration identified in 2004, the year the agency warned the public about the drugs’ risks in children. After the warning, suicides among American youth increased, and some mental health experts said reluctance to try antidepressants might be to blame.

The new analysis, being reported Wednesday in The Journal of the American Medical Association, includes data from seven studies that the previous F.D.A. analysis did not examine. Among those studies were two large pediatric depression trials whose results were unavailable three years ago.

The researchers analyzed data on 5,310 children and teenagers from 27 studies involving the antidepressants Prozac, Paxil, Zoloft, Celexa, Lexapro, Effexor, Serzone and Remeron. They found that for every 100 treated with antidepressants, about one additional child experienced worsening suicidal feelings above what would have occurred without drug treatment. In contrast, the F.D.A. analysis had found an added risk affecting about two in 100 patients. There were no suicides in any of the studies.

“The medications are safe and effective and should be considered as an important part of treatment,” said one co-author of the new analysis, Dr. David Brent of the University of Pittsburgh School of Medicine. “The benefits seem favorable compared to the small risk of suicidal thoughts and behavior.”

Reuters reported that the F.D.A. had no plans to soften or eliminate antidepressants’ warning labels as a result of the new research. “At this time nothing indicates a need for change in the ‘black box’ warning, which urges attention to patients starting treatment,” said Dr. Thomas Laughren, director of the agency’s division of psychiatry products.

The new analysis found that antidepressants worked best when used to treat anxiety. They worked moderately well in treating obsessive-compulsive disorders. They worked less well, though still effectively, in treating depression.

Adolescents responded better than children to treatment for depression and anxiety, the researchers found. They also found that only Prozac worked better than dummy pills in depressed children younger than 12.

In the studies involving depression, 61 percent of patients improved while on antidepressants. But 50 percent of depressed patients taking dummy pills also improved.

Among young patients with obsessive-compulsive disorders, 52 percent improved on antidepressants, compared with 32 percent who improved on dummy pills.

And in the studies of anxiety disorders, 69 percent improved on antidepressants and 39 percent improved on dummy pills.

Dr. John March, chief of child and adolescent psychiatry at Duke University Medical Center, called the report “the most comprehensive analysis of the data yet put together.” But he said the suicidal behavior risk, although lower than found by the F.D.A., demanded that doctors and families watch for warning signs.

“You can’t treat kids with these drugs without taking this information into account,” said Dr. March, who was not involved in the study but who does similar research. “You can’t say, ‘Take these and call me in six weeks.’ ”

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