WASHINGTON, Jul 10, 2008 (UPI via COMTEX) -- 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.
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Copyright 2008 by United Press International