FDA warnings affected prescriptions of antidepressants to youth

January 07, 2008

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, one of the JAMA/Archives journals.

"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).

"After the FDA first recommended not treating youth with paroxetine, there was a significant absolute decline in paroxetine use by youth but not significant declines in use of other antidepressants by young people," the authors write. "Similar, though less pronounced, declines occurred in paroxetine treatment of older patients. Following the black box warning, there was a statistically nonsignificant decline in antidepressant treatment of youth, including a significant deceleration in the rate of treatment with SSRIs other than paroxetine."

The warnings appeared to effectively increase the perception of the risks involved with antidepressant treatment, especially in young people, the authors note. "From 1985 to 1999, there was a four-fold national increase in per capita antidepressant prescriptions," they write. "The FDA warnings appear to have slowed this longer-term growth of antidepressant treatment of children and adults. Despite fears that these advisories might result in a precipitous decline in antidepressant prescribing, it is reassuring that the pattern of changes in treatment, which were modest in size and greatest for treatment of youth, were broadly consistent with the FDA warnings and the scientific literature."
(Arch Gen Psychiatry. 2008;65(1):94-101. Available pre-embargo to the media at www.jamamedia.org.)

Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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