FDA to Boost Suicide Risk Warnings
The U.S. Food and Drug Administration is expected Thursday to recommend black-box warnings on suicide risk for 11 epilepsy drugs.
The agency has put warnings about suicidality –suicide risk and suicidal behavior– on about 35 drugs in the past four years, fueling a debate between groups who say the FDA is overreacting and others who say the risk were ignored previously, The Wall Street Journal reported.
The increase in black-box warnings began in 2004 after the FDA was heavily criticized for taking more than a year to respond to studies linking certain antidepressants to suicidality among children and teens, the newspaper said.
Prior to 2003, it was difficult to determine who to separate drug side effects from the disease the drug was treating. Patients on antidepressants are already at higher risk of suicide and patients is linked with higher rates of depression.