盐酸托莫西汀使用期间 FDA 采取的行动。

Atomoxetine use during a period of FDA actions.

机构信息

Office of Commissioner, US Food and Drug Administration (FDA), 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.

出版信息

Med Care. 2012 Nov;50(11):987-92. doi: 10.1097/MLR.0b013e31826c86f1.

DOI:10.1097/MLR.0b013e31826c86f1

PMID:23047788

Abstract

CONTEXT

The Food and Drug Administration (FDA) issued a Public Health Advisory entitled "Suicidal Thinking in Children and Adolescents Being Treated with Strattera (Atomoxetine)" on September 29, 2005. At FDA's request, the manufacturer subsequently added a boxed warning to the drug's labeling on November 8, 2005.

OBJECTIVE

To evaluate whether the boxed warning for suicidal thinking in atomoxetine's labeling was associated with a change in the pattern of attention-deficit/hyperactivity disorder (ADHD) medication use.

METHODS

Patients who had an ADHD diagnosis and were prescribed either atomoxetine or stimulants between January 2004 and December 2007 were selected from IMS LifeLink Health Plan Claims database. In this ecologic analysis, the outcome measure is the incident atomoxetine use rate, defined as the proportion of atomoxetine incident users among all initial ADHD pharmacotherapy users. The impact of the boxed warning was evaluated using interrupted time series analysis.

RESULTS

A total of 16,311 patients met the definition of incident ADHD medication users. The incident atomoxetine use rate decreased from January 2004 to September 2005 among all age groups (range, -0.45% to -0.74%); and the rate among adult patients decreased by 11.89% (95% confidence interval, 3.05%-20.74%) from September 2005 to November 2005. No long-term impact was detected.

CONCLUSIONS

Significant decline of the atomoxetine use rate was observed before the boxed warning in all age groups. No significant change was detected in the atomoxetine use rate among targeted children or adolescents after the FDA's boxed warning concerning suicidal thinking.

摘要

背景

美国食品和药物管理局（FDA）于 2005 年 9 月 29 日发布了一份题为“接受 Strattera（阿托西汀）治疗的儿童和青少年的自杀意念”的公共卫生咨询。应 FDA 的要求，制造商随后于 2005 年 11 月 8 日在该药物的标签上添加了一个框警告。

目的

评估阿托西汀标签中关于自杀意念的框警告是否与注意缺陷多动障碍（ADHD）药物使用模式的变化有关。

方法

从 IMS LifeLink 健康计划索赔数据库中选择了 2004 年 1 月至 2007 年 12 月期间被诊断为 ADHD 且被处方阿托西汀或兴奋剂的患者。在这项生态分析中，结果测量是阿托西汀的发生率，定义为所有初始 ADHD 药物治疗者中使用阿托西汀的初始使用者比例。使用中断时间序列分析评估框警告的影响。

结果

共有 16311 名患者符合 ADHD 药物治疗者的定义。所有年龄段的患者（范围为-0.45%至-0.74%）的阿托西汀发生率从 2004 年 1 月到 2005 年 9 月有所下降；成年患者的发生率从 2005 年 9 月到 2005 年 11 月下降了 11.89%（95%置信区间，3.05%-20.74%）。未检测到长期影响。