维生素B6注射剂安全性风险分析

doi:10.19803/j.1672-8629.20230067

中国药物警戒 ›› 2023, Vol. 20 ›› Issue (7): 791-794.
DOI: 10.19803/j.1672-8629.20230067

维生素B₆注射剂安全性风险分析

杨乐, 夏东胜, 王涛

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 100022

收稿日期:2023-02-13 出版日期:2023-07-15 发布日期:2023-07-14
作者简介:杨乐,男,本科,副主任药师,药品不良反应监测与评价。E-mail：yangle@cdr-adr.org.cn
基金资助:
国家自然科学基金资助项目（72274065）

Risks to safety of vitamin B₆ injection

YANG Le, XIA Dongsheng, WANG Tao

Center for Drug Reevaluation, NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100022, China

Received:2023-02-13 Online:2023-07-15 Published:2023-07-14

摘要/Abstract

摘要： 目的分析维生素B₆注射剂（维生素B₆注射液、注射用维生素B₆）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2019年6月30日）、世界卫生组织药品不良反应监测数据库（建库至2023年1月31日）、以及其他国内外数据库（建库至2020年12月31日）的不良反应报告以及国内风险控制措施等相关资料进行整理与分析。结果应关注维生素B₆注射剂相关的全身性不良反应、皮肤及其附件、胃肠系统等相关风险。结论药品上市许可持有人应加强维生素B₆注射剂的安全性监测,及时完善产品说明书,促进药品的临床合理使用。

关键词: 维生素B₆, 药品不良反应, 安全性, 风险, 监管措施, 说明书, 上市许可持有人

Abstract: Objective To analyze the risks to safety posed by vitamin B₆ injection 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 June 30, 2019) and WHO Vigilyze (from inception to January 31, 2023), and other databases (from inception to December 31, 2020) were analyzed. Results The risk posed by vitamin B₆ injection, general disorders, and related cutaneous and gastrointestinal system damage deserved more attention. Conclusion Drug marketing authorization holders should reinforce the safety monitoring of vitamin B₆ injection, update the drug labeling in a timely manner and promote the rational use of medicines.

Key words: vitamin B₆, drug adverse reaction, safety, risk, regulatory measures, instruction, drug marketing authorization holders

中图分类号:

杨乐, 夏东胜, 王涛. 维生素B₆注射剂安全性风险分析[J]. 中国药物警戒, 2023, 20(7): 791-794.

YANG Le, XIA Dongsheng, WANG Tao. Risks to safety of vitamin B₆ injection[J]. Chinese Journal of Pharmacovigilance, 2023, 20(7): 791-794.

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维生素B₆注射剂安全性风险分析

Risks to safety of vitamin B₆ injection

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