昂丹司琼制剂安全性风险分析  

Risks to safety of Ondansetron preparations

作　　者：孟康康 夏玉坤 MENG kangkang;XIA Yukun(Center for Drug Reevaluation,NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品评价中心,国家药品监督管理局药物警戒研究与评价重点实验室,北京100075

出　　处：《中国药物警戒》2024年第9期1034-1038,共5页Chinese Journal of Pharmacovigilance

摘　　要：目的 分析昂丹司琼制剂的安全性风险,为临床合理用药提供参考。方法 对我国药品不良反应监测数据库(2004年1月1日至2022年9月30日)、世界卫生组织(WHO)药品不良反应监测数据库(建库至2022年10月31日)以及其他国内外数据库(建库至2023年12月31日)的不良反应报告以及国内外风险控制措施等相关资料进行整理与分析。结果 昂丹司琼严重不良反应报告中,过敏性休克、呼吸困难、肝功能损害不良反应突出;在孕期使用昂丹司琼有导致胎儿唇腭裂的风险,产妇若在分娩前后使用本品,应暂停哺乳。结论 医疗机构需关注昂丹司琼制剂的致畸风险,在孕妇中使用应权衡利弊。同时,药品上市许可持有人应及时完善产品说明书,加强和医疗机构的风险沟通,促进药品的合理使用。Objective To analyze the risks to safety posed by Ondansetron in China in order to provide reference for clinical rational drug use.Methods The individual cases of adverse drug reactions retrieved from China adverse drug reaction database(from January 1,2004 to September 30,2022)and WHO Vigilyze(from inception to October 31,2022)and other databases(from inception to December 31,2023)were analyzed.Results In the serious adverse reaction report of ondansetron,adverse reactions such as anaphylactic shock,dyspnea,and liver dysfunction are prominent.ondansetron in pregnancy is associated with a risk of cleft lip and palate.If pregnant women use ondansetron before and after delivery,breastfeeding should be suspended.Conclusion Medical institutions should pay attention to the teratogenic risk of Ondansetron and weigh the risk and benifit before using it in pregnant women.The drug marketing authorization holder should update the drug labeling in time,strengthen the risk communication with medical institutions,and promote the rational use of medicines.

关 键 词：昂丹司琼 药品不良反应 胎儿 致畸风险 唇腭裂 监管措施 说明书 

分 类 号：R994.11[医药卫生—毒理学]