Impact of FDA Black Box Advisory on Antipsychotic Medication Use
Impact of FDA Black Box Advisory on Antipsychotic Medication Use
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DOI：
10.1001/archinternmed.2009.456
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发表时间：
2010-01-11
影响因子：
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通讯作者：
Alexander, G. Caleb
中科院分区：
文献类型：
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作者：
Dorsey, E. Ray;Rabbani, Atonu;Alexander, G. Caleb
背景资料：2005年4月，美国食品和药物管理局（FDA）发布了关于老年痴呆症患者使用非典型抗精神病药物风险的咨询和随后的黑盒警告。这些警告对非典型药物使用的影响是unknown.Methods：我们使用准实验，中断时间序列分析，以检查从IMS健康的国家疾病和治疗指数从2003年1月至2008年12月的全国代表性数据。对办公室医生的审计的主要测量是非典型抗精神病药物的使用。我们量化的影响咨询非典型抗精神病药物的使用在所有个人和那些65岁或以上的痴呆症。结果：从2003年1月至2005年3月，提到总的非典型抗精神病药物增加了34%，在痴呆症患者中，16%。在FDA发布公告的前一年，大约有1360万例非典型药物被提及，其中包括80万例痴呆症患者。在咨询后的一年里，非典型药物提及总体下降了2%，痴呆症患者下降了19%。2004年，19%（410万中的0.8）的痴呆症药物是非典型药物。到2008年，这一比例下降到9%（430万人中的4%）。非典型药物的使用减缓FDA批准和标签外的适应症，并下降到2008年为所有人口examined.Conclusion：FDA的咨询与非典型抗精神病药物的使用减少，特别是老年痴呆症患者。
Background: In April 2005, the US Food and Drug Administration (FDA) issued an advisory and subsequent black box warning regarding the risks of atypical antipsychotic use among elderly patients with dementia. The impact of these warnings on atypical drug use is unknown.Methods: We used quasi-experimental, interrupted time-series analyses to examine nationally representative data from IMS Health's National Disease and Therapeutic Index from January 2003 through December 2008. The primary measurement from this audit of office-based physicians was the use of an atypical antipsychotic agent. We quantified the impact of the advisory on atypical antipsychotic use among all individuals and those 65 years or older with dementia.Results: From January 2003 to March 2005, mentions of total atypical antipsychotic drugs increased at an an-nual rate of 34%, and among patients with dementia, 16%. in the year prior to the FDA advisory, there were approximately 13.6 million atypical drug mentions, including 0.8 million among those with dementia. In the year following the advisory, atypical drug mentions fell 2% overall and 19% among those with dementia. In 2004, 19% (0.8 of 4.1 million) of drug mentions for dementia were for an atypical agent. By 2008, this proportion decreased to 9% (0.4 of 4.3 million). Atypical drug use slowed for both FDA-approved and off-label indications and declined through 2008 for all populations examined.Conclusion: The FDA advisory was associated with decreases in the use of atypical antipsychotics, especially among elderly patients with dementia.