NDLI: Antidepressants and suicide risk: how did specific information in FDA safety warnings affect treatment patterns?

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Busch, Susan H. Frank, Richard G. Leslie, Douglas L. Martin, Andrés Rosenheck, Robert A. Martin, Erika G. Barry, Colleen L.
Spatial Coverage	United States
Description	Country affiliation: United States Author Affiliation: Busch SH ( Yale School of Public Health, P.O. Box 208034, Suite 300, New Haven, CT 06520-8034, USA. susan.busch@yale.edu)
Abstract	OBJECTIVE: From June 2003 through October 2004, the U.S. Food and Drug Administration (FDA) released five safety warnings related to antidepressant use and the increased risk of suicidality for children. Although researchers have documented a decline in antidepressant use among children over this period, less is known about whether specific safety information conveyed in individual warnings was reflected in treatment patterns. METHODS: Thomson Reuters MarketScan claims data (2001-2005) for a national sample of privately insured children were used to construct treatment episodes (N=22,689). For each new episode of major depressive disorder, it was determined whether treatment followed specific recommendations included in warnings released by the FDA. Treatment recommendations pertained to the use of the antidepressants paroxetine and fluoxetine and to patient monitoring. Treatment patterns were expected to change as the risk information conveyed by the FDA changed over time. RESULTS: The timing of FDA recommendations was associated with trends in the use of paroxetine and fluoxetine by children with major depressive disorder who were initiating antidepressant treatment. However, no evidence of increases in outpatient visits (indicative of monitoring) among depressed children initiating antidepressant use was found. CONCLUSIONS: Release of specific risk and benefit information by the FDA was associated with changes in prescribing but not in outpatient follow-up. These results suggest that the FDA plays an important role in communicating information to the public and providers. Yet, although public health safety warnings were associated with changes in some practice patterns, not all recommendations conveyed in warnings were followed.
File Format	HTM / HTML
ISSN	10752730
e-ISSN	15579700
DOI	10.1176/appi.ps.61.1.11
Journal	Psychiatric Services
Issue Number	1
Volume Number	61
Language	English
Publisher	American Psychiatric Association
Publisher Date	2010-01-01
Publisher Place	United States
Access Restriction	Open
Subject Keyword	Discipline Psychiatry Antidepressive Agents Contraindications Drug Labeling Physician's Practice Patterns Suicide Psychology United States Food And Drug Administration Insurance Claim Review Risk Reduction Behavior Research Support, N.i.h., Extramural
Content Type	Text
Resource Type	Article
Subject	Psychiatry and Mental Health

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