FDA urges young adult warning on antidepressants

Wed May 2, 2007 6:18pm EDT
 
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By Lisa Richwine

WASHINGTON (Reuters) - Warnings on antidepressant drugs should be expanded to say the risks of suicidal thoughts and behavior extend to adults ages 18 to 24, U.S. health officials said on Wednesday.

The danger decreases, however, for adults 65 and older when they take the medicines, the Food and Drug Administration said. New warning labels should note that finding and stress that depression and some other psychiatric disorders are themselves a major causes of suicide, officials said.

The drugs already come with strong warnings that taking them may increase the chances of suicidal thoughts or actions in children and teenagers. Many psychiatrists have criticized the warnings, saying they scare people away from effective treatment and may have contributed to an increase in suicide in recent years.

Millions of Americans take antidepressants. The drugs include Wyeth's Effexor, Pfizer Inc.'s Zoloft, GlaxoSmithKline Plc's Paxil, Eli Lilly and Co's Prozac and Cymbalta, and Forest Laboratories Inc.'s Lexapro.

The FDA reviewed 295 studies of various antidepressants that included more than 77,000 adults.

The analysis found a "slight increase" in suicidal thinking and behavior among young adults during early treatment, which was generally the first one to two months, the FDA said. The data did not find a higher risk for adults older than 24.

For every 1,000 patients treated, about five more cases of suicidal thoughts and actions were reported among 18- to 24-year-olds who took the drugs rather than a placebo.

"The risk is quite small, but we think it is a real risk and it's something that needs to be paid attention to," Dr. Thomas Laughren, director of the FDA's division of psychiatry products, told reporters.  Continued...

 
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