Pharmaceutical Research

FDA warnings appear to lead to appropriate prescriber action

When the U.S. Food and Drug Administration (FDA) issues a warning about a drug, the media typically seize upon that information and spread the news to the public. However, it is unknown if clinicians respond similarly. To determine physician reaction to FDA warnings, researchers examined prescribing trends for antidepressants for youth, adults, and older adults before an FDA warning, after a warning, and after a black box warning was issued for prescribing paroxetine (Paxil™) to youth in 2004.

A black box warning is the strongest measure the FDA can take, short of pulling the drug from the market. The researchers found that the FDA warnings did have their intended effect and led to a decrease in prescriptions for antidepressants in youth.

Using data from the largest pharmacy benefit management service, the researchers found that in the prewarning period, from 2002 to 2003, antidepressant use for youths aged 6 to 17 increased at a rate of 36 percent a year. Once the FDA issued its warning linking paroxetine with youth suicides, the rate of antidepressant prescriptions for youth declined 0.8 percent from 2003 to 2004. Once a black box warning appeared on the drug, youth prescriptions for paroxetine fell 9.6 percent from 2004 to 2005. This trend in declining antidepressant use did not hold true for adults aged 18 to 64. After the FDA warnings were issued, adults tended to switch paroxetine for other antidepressants instead of abandoning those drugs altogether.

The authors state that the FDA warnings resulted in a modest decrease in youth antidepressant use; however, clinicians continued to prescribe antidepressants for youth in a manner consistent with the warnings and scientific literature. This study was funded in part by the Agency for Healthcare Research and Quality (HS16097).

See "Effects of Food and Drug Administration warnings on antidepressant use in a national sample," by Mark Olfson, M.D., M.P.H., Steven C. Marcus, Ph.D., and Benjamin G. Druss, M.D., M.P.H., in the January 2008 Archives of General Psychiatry 65(1), pp. 94-101.

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