FDA Mandates Suicide Risk Assessment in Drug Trials

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. (More FDA stories.)