Implementation of US FDA boxed warning in drug labels from 2019 to 2024 and comparison with relevant situations in China
10.3760/cma.j.cn114015-20250114-00028
- VernacularTitle:2019年至2024年美国FDA药品说明书黑框警告的实施及与我国相关情况对比的研究
- Author:
Yinan ZHANG
1
;
Wenshuo JIANG
;
Xiao ZHANG
;
Yilong YAN
;
Zhigang ZHAO
Author Information
1. 首都医科大学附属北京天坛医院药学部，北京 100070
- Publication Type:Journal Article
- Keywords:
Drug labeling;
Boxed warning;
Warning statements;
Medication safety
- From:
Adverse Drug Reactions Journal
2025;27(10):621-628
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate the implementation of boxed warning of drug labels in US Food and Drug Administration (FDA) from 2019 to 2024, and compared it with the relevant situations in China, in order to provide reference for the revision of drug labels and safe drug use.Methods:Data on boxed warning revisions in the US FDA "Drugs Safety Related Labeling Changes" Database from January 1, 2019 to December 31, 2024 were retrieved, and the revised contents were classified. The drug labels for newly marketed drugs in the United States during the same period were collected, the boxed warnings were recorded and summarized, and compared with the warning statements in drug labels of relevant drugs approved in China.Results:From 2019 to 2024, FDA revised boxed warnings in 209 drug labels. Among them, 22 items (10.53%) were newly added, 63 items (30.14%) were major updates, 115 items (55.02%) were minor updates, and 9 items (4.31%) were removed. A total of 293 new drugs were approved in the United States from 2019 to 2024, of which 69 (23.55%) had boxed warnings when they were approved, and 4 (1.37%) were added boxed warnings when they were revised in the labels. Up to December 31, 2024, 92 of the 293 new drugs had been approved in China. Compared with the labeling in the United States, some drugs lacked warning statements section in China, including zolpidem tartrate, dexzopiclone, zaleplon, montelukast sodium, denosumab, terlipressin, etc.Conclusions:The warning statements in some Chinese drug labels are inconsistent with the boxed warnings in the American drug labels. It is suggested that the revision of the boxed warning by US FDA should be regarded as one of the new sources of safety information to assess the risks of related drugs and determine whether it is necessary to revise the relevant drug labels in China.
