Analysis and suggestions for the FDA drug labeling rules on cardiac safety risk warnings
10.13699/j.cnki.1001-6821.2025.02.017
- VernacularTitle:FDA药物说明书心脏安全性风险警示规则分析与建议
- Author:
Wei LIU
1
;
Xiao-qing XING
;
Yu-qing REN
;
Qian SHEN
;
Yue ZHOU
;
Nan ZHANG
;
Fu-meng LIANG
;
Fang-fang WANG
;
Hai-yan LI
Author Information
1. 北京大学第三医院药学部,北京 100191;北京大学医学部药物评价中心,北京 100191
- Publication Type:Journal Article
- Keywords:
oncology drug;
drug label;
QT interval prolongation;
cardiac safety;
warning information
- From:
The Chinese Journal of Clinical Pharmacology
2025;41(2):235-239
- CountryChina
- Language:Chinese
-
Abstract:
Objective To improve and refine the relevant regulations and guiding principles of warnings on drug instructions and labels in China.Methods This paper sorted out the drug instructions of small molecule anti-tumor drugs listed by the U.S.Food and Drug Administration(FDA)from 2005 to 2022,included the drugs mentioned in the QT interval prolongation risk,analyzed the clinical research and QT research results,and sorted out the identification and warning rules of the instructions.Results A total of 35 drugs were included,4 drugs wrote the risk of QT interval prolongation in the black box warning,21 drugs were wrote in the warning and precautions position,6 drugs were wrote in the adverse reaction section,and 2 drugs were only described under clinical pharmacology section.According to the severity of the QT interval prolongation caused by the drug and whether there were serious clinical consequences,they were displayed in the warnings(black box warnings),precautions(warnings and precautions)and adverse reactions in the instructions.Conclusion The aim of this article is to provide a reference for the writing of QT risk warning information of the instructions of domestic drug production enterprises and regulatory departments.It is recommended to clarify the severity of drug safety and the location of the instructions in clinical research,and continue to carry out safety monitoring and update the instructions in time after listing.
