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Regulatory warnings led to decreased use of antidepressants in children and adolescents in 2004 and 2005

According to a new study, regulatory warnings which cautioned that initiating antidepressants could potentially increase suicidal thoughts and behavior in children and adolescents led to fewer new pediatric prescriptions of antidepressants in 2004 and 2005. Two regulatory agencies, the United Kingdom (UK) Committee on Safety of Medicines (CSM) and the U.S. Food and Drug Administration issued the warnings in late 2003 and 2004.

The CSM warning excluded fluoxetine (Prozac®), the one antidepressant whose efficacy has been established in children; however, it was included in the FDA warnings. The FDA warnings did not suggest avoiding antidepressants in pediatric patients, rather they recommended more intense therapeutic monitoring, note Wayne A. Ray, Ph.D., and colleagues at the Vanderbilt Center for Education and Research on Therapeutics.

Dr. Ray and colleagues studied antidepressant prescribing among children insured by TennCare, Tennessee's Medicaid program, during the period before the CSM warning (January 1, 2002 through December 31, 2003) and after the warning (January 1, 2004 through September 30, 2005). During the 2 years preceding the UK warning, the trend for new antidepressant users remained the same, with about 23 new users per 10,000 persons per month.

However, new users of all antidepressants decreased by 33 percent among both children and adolescents by 21 months after the UK warning. This was most pronounced among new prescriptions for the most common nonfluoxetine antidepressants, which decreased by 54 percent. In contrast, new users of fluoxetine, which was not included in the UK warning, increased 60 percent. There was no increase in discontinuations of antidepressants, and there was no evidence of substitution of other psychotropic drugs. Whether these prescribing changes are desirable is uncertain. The authors conclude there is an urgent need for better safety and efficacy data to guide pediatric antidepressant practice.

This study was supported in part by the Agency for Healthcare Research and Quality (HS10384).

See "Effect of regulatory warnings on antidepressant prescribing for children and adolescents," by Benji T. Kurian, M.D., M.P.H., Dr. Ray, Patrick G. Arbogast, Ph.D., and others, in the July 2007 Archives of Pediatric and Adolescent Medicine 161(7), pp. 690-696.

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