布雷克萨诺龙在患有产后抑郁症的成年人中的安全性:营销后监测数据
Svetlana Garafola1, Elizabeth Shiferaw2, Vikram Dev2
1Sage Therapeutics, Inc., Cambridge, MA, USA. lana.garafola@sagerx.com.
Drugs - real world outcomes
|June 6, 2023
概括
布雷克萨诺龙治疗产后抑郁症 (PPD) 的安全性表现与其处方信息一致. 营销后监测没有发现这种PPD药物的新安全问题.
科学领域:
- 药物监督 药物监督 药物监督
- 神经科学是一个神经科学.
- 妇女健康 妇女健康
背景情况:
- 布雷克萨诺龙是FDA批准的唯一一种用于15岁及以上个体的产后抑郁症 (PPD) 的药物.
- 由于镇静和失去意识的风险,其使用受到风险评估和缓解策略 (REMS) 的限制.
研究的目的:
- 评估布雷克萨诺龙在经诊断为PPD的成年患者的营销后安全性.
- 为了识别任何新的安全信号或改变与布雷克萨诺隆治疗相关的已知风险.
主要方法:
- 对2019年3月至2021年12月的累计营销后不良事件 (AE) 报告 (个人病例安全报告 - ICSR) 的分析.
- 排除临床试验ICSR;根据FDA的标准和处方信息将副作用分类为严重/不严重和列出/未列出.
主要成果:
- 499名患者在营销后接受了布雷克萨诺龙.
- 137个ICSR报告了396个副作用,包括严重的未列出事件,严重的列出事件,不严重的未列出事件和不严重的列出事件.
- 报告了两个严重的和一个不严重的过度镇静副作用,所有这些都在输液停止后没有进一步干预就消失了;没有意识丧失事件发生.
结论:
- 营销后监测数据与FDA批准的处方信息中详细介绍的布雷克萨诺龙的确立安全概况一致.
- 没有发现新的安全问题或新出现的风险,需要更新布雷克萨诺隆处方信息.
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