U.S. Food and Drug Administration warnings regarding the risk of suicidal thoughts and behaviors in children and adolescents taking antidepressants appear to have had modest and targeted effects on the intended populations, according to a report in the January issue of Archives of General Psychiatry.
“The possibility that antidepressant medications, especially selective serotonin reuptake inhibitors (SSRIs), increase the risk of suicidal behavior was first raised in several case reports of children and adults during the early 1990s,” the authors write as background information in the article. “In June 2003, the Food and Drug Administration (FDA) recommended that paroxetine hydrochloride not be used to treat young people because of potential increased risk of suicidal behavior, and in October 2004, the FDA issued a black box warning concerning all antidepressants for youth.” This warning received extensive media attention and is the strongest action the FDA can take other than withdrawing approval for a drug.
Mark Olfson, M.D., M.P.H., of the Columbia University Medical Center, New York, and colleagues analyzed trends in antidepressant use based on data from Medco, a company that manages prescription drug benefits. The researchers assessed antidepressant prescriptions for youth (age 6 to 17), adults (age 18 to 64) and older adults (age 65 and older) over three time periods: prewarning (May 1, 2002, to June 19, 2003), paroxetine warning (June 20, 2003, to Oct. 15, 2004) and black box warning (Oct. 16, 2004, to Dec. 31, 2005).