首页|基于OpenFDA对布瓦西坦药物不良反应的分析

基于OpenFDA对布瓦西坦药物不良反应的分析

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目的 探究布瓦西坦的药物不良反应,评价上市后不良反应,为该药的临床用药提供参考依据.方法 收集2016 年2 月18 日至2023年6 月30 日美国FDA不良事件报告系统(FAERS)中布瓦西坦不良事件报告.结果 共收到布瓦西坦的不良事件报告数为3955 份,美国上报最多,严重不良反应占比超80%,不良反应中超说明书用药占比超14%.挖掘出说明书未提及的不良反应如记忆障碍、认知障碍、腹泻、复视、脱发、低钠血症等.结论 在应用布瓦西坦时,要警惕超说明书用药,注意说明书外的不良反应,开展必要的药学监护.
Analysis of the Adverse Drug Reactions for Brivaracetam Based on Open FDA
OBJECTIVE To explore the adverse drug reactions of brivaracetam,evaluate the adverse reactions after marketing,and provide a reference for the clinical use of the drug.METHODS The adverse event reports of brivaracetam collected in the US FDA Adverse Event Reporting System(FAERS)from February 18,2016 to June 30,2023.RESULTS A total of 3955 ADR reports were received from brivaracetam,with the United States reported the most,with serious adverse reactions accounting for more than 80%,and off-label drugs accounting for more than 14%of adverse reactions.Unearthed adverse reactions not mentioned in the instructions,such as memory impair-ment,cognitive disorder,diarrhea,diplopia,alopecia hyponatremia,etc.CONCLUSION When applying brivarace-tam,it is necessary to be vigilant against off-label use,pay attention to adverse reactions outside the label,and carry out necessary pharmaceutical monitoring.

BrivaracetamAdverse reactionsOff-label use

钟路生

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深圳市宝安区人民医院,广东深圳 518191

布瓦西坦 不良反应 超说明书用药

2024

海峡药学
中国药学会福建分会

海峡药学

影响因子:0.643
ISSN:1006-3765
年,卷(期):2024.36(4)
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