Update: FDA looks for link between antidepressants, child suicide
Published February 2, 2004


FDA panel to weigh possible link between antidepressants and child suicide

Today: A government panel of doctors will meet to weigh disturbing but ambiguous evidence that widely used antidepressants may make some children suicidal, concerns that peaked in December when British authorities warned doctors not to prescribe the drugs to children.

Clinical trials conducted by the drug industry in recent years have produced a steady stream of data suggesting that suicidal thoughts and behavior are slightly more likely to develop in depressed children who take antidepressants such as Paxil, Zoloft and Effexor than in children who get a placebo, according to several scientists who have analyzed many of the studies.

The Food and Drug Administration, after concluding that the numbers in each trial were too small to settle the question, has mounted its own detailed review of the studies and convened the expert panel to advise it on how to evaluate the data.

If the danger is real, thousands of U.S. children are potentially at risk. About 1 percent of children in the United States have depression diagnosed each year, according to a recent review, and more than half of those are prescribed antidepressants.

Conflicting reports: Last month, a panel convened by the American College of Neuropsychopharmacology (ACNP) reported that in drug company-sponsored trials involving 1,921 children on Prozac, Paxil, Zoloft and Celexa, 47 children developed suicidal thoughts or harmed themselves. By contrast, 32 children taking placebos showed suicidal behavior.

The panel of psychiatrists said the difference was not statistically significant. The doctors, who reflect the prevailing view of U.S. psychiatrists, said they believe the medicines significantly reduce the risk of suicide among depressed children.

Others who have seen the same data strongly disagree.

"Across all of these drugs, the rate of children who become suicidal is 2.5 times higher than on placebo," said David Healy, a Welsh psychiatrist who has reviewed several unpublished industry studies, including those analyzed by the ACNP panel. Healy is an expert witness in several lawsuits against pharmaceutical companies.

Washington Post

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