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

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.