Signal mining and analysis of drugs related to medication-related osteonecrosis of the jaw based on FAERS database
10.3969/j.issn.1001-3733.2025.05.010
- VernacularTitle:基于FAERS数据库的颌骨坏死相关药物信号挖掘
- Author:
Youjun CHEN
1
;
Guoxin REN
Author Information
1. 200125,上海交通大学口腔医学院
- Publication Type:Journal Article
- Keywords:
Medication-related osteonecrosis of the jaw;
FDA adverse event reporting system;
Adverse drug reactions;
Drug signal mining
- From:
Journal of Practical Stomatology
2025;41(5):636-642
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To analyze the adverse drug reaction(ADR)signals of medication-related osteonecrosis of the jaw(MRONJ)through mining data from the USA FDA adverse event reporting system(FAERS),and to explore potential MRONJ-re-lated drug in order to provide a basis for clinical safety and rational drug use.Methods:The reporting odds ratio(ROR),propor-tional reporting ratio(PRR)and Bayesian Confidence interval Progressive Neural Network(BCPNN)methods were used for data mining and signal detection of MRONJ adverse event reports in FAERS for 80 quarters from the first quarter of 2004 to the fourth quarter of 2023.Results:A total of 22 214 adverse reaction reports of MRONJ were collected,with a male to female ratio of approximately 1∶2;The majority of patients is over 50 years old,with a total of 14 463 cases(65.10％).The United States and Japan were the countries with the most reports,6 589(29.66％)and 3 459(15.57％)respectively.China(including Taiwan)also reported cases.After screening,a total of 31 drugs were found to be associated with the occurrence of MRONJ,involving 19 757 reports,including 8 antiresorptive agents and 19 antineoplastic agents.Among them,there were 18 061 reports of antire-sorptive agents,and the drug label of 17 drugs did not list osteonecrosis as adverse reactions.Conclusion:Antiresorptive agents represented by bisphosphonates and some antineoplastic agents are the major risk medication for the occurrence of MRONJ.
