After decades of inattention to the possible psychiatric side effects of experimental medicines, the Food and Drug Administration is now requiring drug makers to study closely whether patients become suicidal during clinical trials. The new rules represent one of the most profound changes of the past 16 years to regulations governing drug development. But since the F.D.A.’s oversight of experimental medicines is done in secret, the agency’s shift has not been announced publicly. The drug industry, however, is keenly aware of the change. Makers of drugs to treat obesity, urinary incontinence, epilepsy, smoking cessation, depression and many other conditions are being asked for the first time by the drug agency to put a comprehensive suicide assessment into their clinical trials. The seeds for the new federal effort were planted four years ago with the discovery that antidepressants may cause some children and teenagers to become suicidal.
To read the entire New York Times article, please click on the following link:
http://www.nytimes.com/2008/01/24/washington/24fda.html?_r=2&hp&oref=slogin&oref=slogin
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