Research on signal mining of adverse event of minocycline based on FAERS database
10.12173/j.issn.1005-0698.202401002
- VernacularTitle:基于FAERS数据库的米诺环素不良事件信号挖掘研究
- Author:
Lu ZENG
1
;
Lu WANG
;
Anhua WEI
;
Lumin ZHOU
Author Information
1. 华中科技大学同济医学院附属同济医院药学部(武汉 430030)
- Keywords:
Minocycline;
FAERS database;
Adverse drug event;
Data mining;
Pharmacovigilence
- From:
Chinese Journal of Pharmacoepidemiology
2024;33(6):632-641
- CountryChina
- Language:Chinese
-
Abstract:
Objective To mine the adverse drug event(ADE)signals of minocycline,to provide a reference for clinical drug safety.Methods The reporting odds ratio(ROR)method,proportional report ratio(PRR)method,the Medicines and Healthcare Products Regulatory Agency(MHRA)method,and Bayesian confidence propagation neural network(BCPNN)method were used to analyze the ADE reports of minocycline based on U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)registration data from first quarter 2004 to fourth quarter 2023,and the signal distribution,signal intensity,gender and age differences,and mortality based on standard MedDRA query(SMQ)were analyzed.Results A total of 16 871 ADE cases of minocycline were screened,and 364 positive ADE signals were mapped to 27 system organ classification(SOC),the most involved SOC were systemic diseases and various reactions at the administration site,skin and subcutaneous tissue diseases,various neurological diseases,etc,and the strong signals with the higher number of ADE cases were drug reaction with eosinophilia and systemic symptoms(DRESS),polyarteritis nodosa and idiopathic intracranial hypertension,and compared to other drugs,the proportion of women with idiopathic intracranial hypertension caused by minocycline was higher(P＜0.05).At the same time,29 cases of ADE in children under 8 years old were obtained,involving 10 SOC,206 deaths and 1 046 associated ADE-related cases,and there were 1 565 cases of hypersensitivity ADE,and 88 PT signals under the hypersensitivity SMQ.Among them,DRESS,urticaria,anti-neutral cytoplasm antibody-positive vasculitis,and facial edema were reported in high numbers and with strong signals.Conclusion The risk of hypersensitivity events and autoimmune diseases should be vigilant in the clinical use of minocycline,and ophthalmic monitoring could be performed especially in female patients if necessary.Attention should be paid to ADE collection and monitoring of minocycline in children under 8 years old.
