After decades of inattention to the possible psychiatric side effects of experimental medicines, the Food and Drug Administration is now requiring drugmakers 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 FDA’s oversight of experimental medicines is done in secret, the agency’s shift has not been announced publicly.
Makers of drugs to treat obesity, urinary incontinence, epilepsy, smoking addiction, depression and many other conditions are being asked to put a comprehensive suicide assessment into their clinical trials. Merck, Sanofi-Aventis and Eli Lilly are all using a detailed suicide assessment in trials being conducted now.
