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FDA Mandates Suicide Risk Assessment in Drug Trials

Danger doesn't lie only in antidepressants

By Katherine Thompson,  Newser Staff

Posted Jan 24, 2008 11:42 AM CST
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(Newser) – The Food and Drug Administration is now requiring drug companies to monitor suicide warning signs in clinical trials for experimental drugs, the New York Times reports. In the wake of studies showing that antidepressants might increase the risk of self-harm in children and teens, the agency is showing an awareness that a surprising variety of drugs can have psychiatric effects.

Clinical trials that must add a suicide assessment to their studies include those for drugs combating epilepsy, incontinence, obesity, and smoking, in addition to depression. Most of these drugs were not previously thought to affect the brain. "Various groups within FDA are now looking at suicidality more broadly as a possible adverse event,” explains one expert.

Young adults face an increased risk of suicidal thoughts and behavior when they first begin taking antidepressants and should be warned about the danger, federal health officials said Wednesday, May 2, 2007. The FDA is looking into the possible dangers of other drugs as well. (AP GRAPHIC)
Young adults face an increased risk of suicidal thoughts and behavior when they first begin taking antidepressants and should be warned about the danger, federal health officials said Wednesday, May 2,...   (Associated Press)
In this undated photo released by German drug maker Merck & Co., an employee controls samples in the molecular biology department. The FDA has begun requiring more detailed studies of the effects of certain experimental drugs on suicide rates. (AP Photo/Merck)
In this undated photo released by German drug maker Merck & Co., an employee controls samples in the molecular biology department. The FDA has begun requiring more detailed studies of the effects of certain...   (Associated Press)
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suicide • FDA • antidepressant • Merck • Sanofi Aventis • Eli Lilly • anti obesity drugs • clinical trials • experimental drugs

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