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.

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.

OBJECTIVE To analyze the standardization and influential factors medication use for the prevention and treatment of glucocorticoid-induced osteoporosis(GIOP).METHODS The data of inpatients diagnosed as rheumatic immune diseases in our hospital from January 1,2022,to December 31,2023,who required long-term use of glucocorticoids,were collected to analyze the risk stratification for GIOP-related fractures and the utilization of prevention and treatment drug in patients.Univariate analysis and Logistic stepwise regression analysis were employed to screen the factors influencing the standardization of prevention and treatment drug use in patients.RESULTS Among 354 patients,148 patients(41.81%)had a low risk of osteoporotic fractures,103 patients(29.10%)had a moderate risk,and 103 patients(29.10%)had a high risk.The top three drugs used in the prevention and treatment of GIOP were calcium supplements(78.81%),vitamin D preparations(74.01%),and anti-osteoporosis drugs(21.19%).A total of 133 patients(37.57%)used the drugs for GIOP prevention and treatment in a standardized manner.The standardization rate of prevention and treatment in patients with low fracture risk was significantly higher than those with high and moderate fracture risk,and the standardization rate in patients with high fracture risk was significantly higher than those with moderate fracture risk(P＜0.05).Besides,the univariate analysis showed that low fracture risk served as a prevention factor for the standardized use of prevention and treatment drugs for GIOP,while moderate fracture risk,smoking or drinking,the occurrence of adverse drug reactions,and having an educational level below junior college were risk factors for the normative use of GIOP prevention and treatment drug(P＜0.05).Logistic stepwise regression analysis showed that patients with low and moderate fracture risk,a history of smoking or drinking,and adverse drug reactions to anti-osteoporosis drugs had a lower standardization rate of prevention and treatment;patients who visited tertiary hospital for the past month and had a longer duration of glucocorticoid use had a higher standardization rate of prevention and treatment(P＜0.05).CONCLUSIONS The standardized rate of prevention and treatment drugs used for GIOP in our hospital is relatively low.Patients with moderate to high fracture risk,a history of smoking or drinking,and those who experience adverse drug reactions after taking anti-osteoporosis drugs have lower rates of standardized prevention and treatment.Conversely,patients who sought treatment at tertiary hospital for the past month and had a longer duration of glucocorticoid had higher rates of standardized prevention and treatment.