药物诱导的低血糖症:FAERS数据库的不成比例分析
Jie Li1, Yilei Wang2, Xiang Yang1
1Department of Pharmacy, Zhangjiagang TCM Hospital, Affiliated to Nanjing University of Chinese Medicine, Zhangjiagang, Jiangsu, China.
Expert opinion on drug safety
|November 1, 2023
概括
低血糖是显著的不良事件. 甲胺与大多数病例有关,而其他药物显示高低血糖风险信号并不总是列在标签上,需要临床监测.
科学领域:
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
- 临床风险管理临床风险管理
背景情况:
- 低血糖是临床实践中一个关键的不良事件.
- 了解与药物相关的低血糖症对于患者的安全至关重要.
- 美国食品和药物管理局的不良事件报告系统 (FAERS) 是药物监测的关键数据来源.
研究的目的:
- 为了确定与低血糖相关的常见和高风险药物.
- 为了分析FAERS数据库的药物诱导低血糖信号.
- 将已识别的风险与药物标签信息进行比较.
主要方法:
- 使用OpenVigil 2.1平台对FAERS数据库进行查询 (2004-2023年).
- 监管活动的雇员医学词典 (MedDRA) 用于低血糖病例的识别.
- 应用不相称性分析 (ROR,PRR) 来评估与药物相关的风险.
主要成果:
- 分析了超过1100万份不良事件报告,其中28443份 (0.25%) 与低血糖有关.
- 甲福明是与低血糖相关的最常见的药物 (6926例).
- 美西林,尼基他胺,索塔格利弗洛辛,诺雷桑德罗隆和格利梅皮里德/皮奥格利塔显示出最高的风险信号;在前50种药物中,有19种药物在标签上缺乏低血糖警告.
结论:
- 在FAERS分析中,发现了具有显著低血糖信号的药物,这些信号在产品标签上没有得到充分反映.
- 这些发现强调了监测潜在的低血糖风险的重要性,即使在药物插件中没有明确说明.
- 临床警和更新的标签对于有效管理与药物相关的低血糖至关重要.
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