Real-world study evaluating novel tetracycline adverse drug reactions based on the FAERS database
10.13699/j.cnki.1001-6821.2024.16.021
- VernacularTitle:基于FAERS数据库的真实世界研究评估新型四环素的药物不良反应
- Author:
Fei WANG
1
;
Jie ZHANG
;
Wei ZHUANG
;
Hua-Lun LIANG
Author Information
1. 广州中医药大学第二附属医院二沙岛医院药剂科,广东广州 510515
- Keywords:
tetracycline;
adverse events;
Food and Drug Administration Adverse Event Reporting System;
signal mining;
pharmacovigilance
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(16):2401-2404
- CountryChina
- Language:Chinese
-
Abstract:
Objective To provide references for the individualized medicine of tetracyclines through mining the adverse drug events(ADE)signal.Methods All the ADE data were obtained from the Food and Drug Administration adverse event reporting system.The reports of primary suspect for tigecycline,omadacyeline or eravacycline were extracted and analyzed by using the reporting odds ratio(ROR)method.Results We identified 5 896 reports of ADE related to tetracyclines,and 99,37 and 8 ADE signals of tigecycline,omadacyeline and eravacycline,respectively.The safety profile of tetracyclines varies.The highest signal intensities of tigecycline were observed in thrombin time prolonged and amylase abnormal.Drug dose titration not performed and tooth discolouration were the highest signal intensities of omadacyeline,while blood fibrinogen decreased and pancreatic enzymes increased were found the highest signal intensities of eravacycline.Meanwhile,the main ADE signals in tigecycline were found in hepatobiliary(ROR=7.15)and blood and lymphatic systems(ROR=4.95),while gastrointestinal system in omadacyeline(ROR=3.32),and investigations(ROR=2.79)and vascular systems(ROR=2.72)in eravacycline,respectively.Furthermore,we also found ADE signals not reported in previous studies,such as sleep disorders and methemoglobinemia.Conclusion The safety profiles of tigecycline,omadacyeline and eravacycline varies.Individualized drug selection and monitoring of ADE according to the characteristics of tetracyclines are needed during treatment.
