The FDA (Food and Drug Administration) warnings about suicidal thoughts linked to antidepressant use among children/adolescents seems to have had some effect on prescribing, says an article in Archives of General Psychiatry (JAMA/Archives).
The authors wrote “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. 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.”
The warning(s) got lots of media attention. It is the strongest action the FDA can take before withdrawing a drug from the market.
Mark Olfson, M.D., M.P.H., the Columbia University Medical Center, New York, and team looked at the trends in antidepressant prescribing from the Medco database. Medco is a company that manages prescription drug benefits.
The researchers focused on antidepressant prescribing over three time periods for –
— Patients aged 6-17
— Patients 18-64
— Patients aged 65 or more
The three time periods were
— prewarning – May 1, 2002, to June 19, 2003
— paroxetine warning – June 20, 2003, to Oct. 15, 2004
— black box warning – Oct. 16, 2004, to Dec. 31, 2005
The authors wrote “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. 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.”
“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.”
“Effects of Food and Drug Administration Warnings on Antidepressant Use in a National Sample”
Mark Olfson, MD, MPH; Steven C. Marcus, PhD; Benjamin G. Druss, MD, MPH
Arch Gen Psychiatry. 2008;65(1):94-101.
Written by – Christian Nordqvist