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some antidepressants used in children after new analyses back a possible link to suicide
Federal health officials are preparing stronger warnings for some antidepressants used in children after new analyses back a possible link to suicide. Exactly what those warnings will say, and which drugs will be affected, hasn't been settled, according to Food and Drug Administration documents released Friday. The agency will ask its scientific advisers next month for help in deciding. "While there remains a signal of risk ... for some drugs in some trials, it is important to note that the data are not black-and-white in providing a clear and definitive answer," FDA psychiatric drugs chief Dr. Thomas Laughren wrote the advisory panel this week, CBS News reported. According to the ABC News, Mosholder testified before two FDA panels considering whether agency action including stronger warning labels is needed on antidepressants because they have been linked to suicidal tendencies among children who take them. The joint panel will weigh the benefits of nine drugs given to depressed children against the risk that the remedies may increase suicidal thoughts and suicidal actions among those youths. Mosholder said analyses of data confirmed "an association of suicidality with antidepressant drug treatment." He was praised by grieving family members, who wore pins and carried posters and oversized photographs of deceased children whose deaths they blame on antidepressants. Last year, he had requested clarification from GlaxoSmithKline and received data in May 2003 that suggested a link between the company's drug Paxil and increased suicidal acts among children taking the antidepressant. Another FDA reviewer, Dr. Tarek Hammad, also said the studies reviewed by Mosholder, other FDA staff and Columbia University suggested a link between antidepressant use and suicidal tendencies in youth. For every 100 patients treated with an antidepressant, two or three might have a higher risk of suicidal behavior, beyond the risk inherent from depression, Hammad estimated, informs Reuters.
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