Guest guest Posted March 22, 2004 Report Share Posted March 22, 2004 FDA Urges Caution Over Antidepressant Use 1 hour, 44 minutes ago Add Top Stories - Reuters to My WASHINGTON (Reuters) - Patients taking anti-depressants, including children and teenagers, should be closely monitored for signs of worsening depression and suicidal thoughts, U.S. health authorities said on Monday. Reuters Photo The warning comes after a panel of experts last month called on the U.S. Food and Drug Administration (news - web sites) to issue stronger warnings about the possible risks of suicidal behavior among children and teenagers taking antidepressant drugs. U.S. health officials are studying whether antidepressants can make children and teenagers suicide-prone but have not yet reached a conclusion. "It is not yet clear whether antidepressants contribute to the emergence of suicidal thinking and behavior," the FDA said in a statement. Questions about a possible link with suicidal behavior arose last year when regulators were reviewing clinical trials of children who took GlaxoKline Plc's Paxil. The other antidepressants the FDA is evaluating include Forest Laboratories Inc.'s Celexa, Solvay's Luvox, Akzo Nobel's Remeron, Bristol-Myers Squibb's Serzone, Pfizer's Zoloft, Eli Lilly and Co.'s Prozac, and Wyeth's Effexor. Only Prozac, sold generically as fluoxetine, is approved for treating pediatric depression. The FDA advised patients and doctors watch for signs of hostility, anxiety, insomnia and other behaviors that could signal worsening depression and suicidal thoughts. The agency asked manufacturers to change the labels of 10 drugs to include stronger warnings about patient monitoring. Quote Link to comment Share on other sites More sharing options...
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