Antidepressants and Suicide Risk: How Did Specific Information in FDA Safety Warnings Affect Treatment Patterns?
Antidepressants and Suicide Risk: How Did Specific Information in FDA Safety Warnings Affect Treatment Patterns?
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DOI：
10.1176/appi.ps.61.1.11
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发表时间：
2010-01-01
影响因子：
3.8
通讯作者：
Barry, Colleen L.
中科院分区：
文献类型：
--
作者：
Busch, Susan H.;Frank, Richard G.;Barry, Colleen L.
目的：从 2003 年 6 月到 2004 年 10 月，美国食品和药物管理局 (FDA) 发布了五项与抗抑郁药使用和儿童自杀风险增加相关的安全警告。尽管研究人员记录了这一时期儿童抗抑郁药物使用量的下降，但人们对个人警告中传达的具体安全信息是否反映在治疗模式中知之甚少。方法：汤森路透 MarketScan 声称全国私人保险儿童样本的数据（2001-2005 年）被用来构建治疗事件（N = 22,689）。对于重度抑郁症的每次新发作，都会确定治疗是否遵循 FDA 发布的警告中包含的具体建议。治疗建议涉及抗抑郁药帕罗西汀和氟西汀的使用以及患者监测。随着 FDA 传达的风险信息随着时间的推移而变化，治疗模式预计也会发生变化。结果：FDA 建议的时机与开始抗抑郁治疗的重度抑郁症儿童使用帕罗西汀和氟西汀的趋势相关。然而，没有发现证据表明开始使用抗抑郁药物的抑郁儿童的门诊量（表明监测）有所增加。结论：FDA 发布的具体风险和获益信息与处方变化相关，但与门诊随访无关。这些结果表明 FDA 在向公众和提供者传达信息方面发挥着重要作用。然而，尽管公共卫生安全警告与某些实践模式的变化有关，但并非警告中传达的所有建议都得到遵循。 （精神科服务 61：11-16，2010 年）
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. (Psychiatric Services 61: 11-16, 2010)