Safety Evaluation of Tetracyclines in Children Based on the FAERS Database
10.3870/j.issn.1004-0781.2025.05.021
- VernacularTitle:基于FAERS的未成年人使用四环素类药物的安全性评价
- Author:
Yanqu ZHOU
1
;
Haotian FEI
;
Chengliang WANG
;
Li CHEN
Author Information
1. 四川大学华西第二医院药学部,成都 610041
- Publication Type:Journal Article
- Keywords:
Tetracycline;
Minocycline;
Tigecycline;
Doxycycline;
Adverse reaction signal;
FDA Adverse Event Reporting System
- From:
Herald of Medicine
2025;44(5):801-811
- CountryChina
- Language:Chinese
-
Abstract:
Objective To detect the adverse drug reaction(ADR)signals of tetracycline representative drugs(tetracy-cline,minocycline,tigecycline,and doxycycline)in children,and to provide reference for safe clinical medication.Methods A total of 34 quarters of ADE report data related to four tetracyclines from the first quarter of 2015 to the second quarter of 2023 in the US FDA Adverse Event Reporting System(FAERS)were collected and grouped according to the age of minor children.The re-port odds ratio(ROR)method and the comprehensive standard method(MHRA)were used for signal mining.Results A to-tal of 367 461 reports were retrieved from the FAERS database for all minor children under 18 years old.There were 43,583,40 and 501 reports related to tetracycline,minocycline,tigecycline and doxycycline,respectively.A total of 280 ADE signals were de-tected after deduplication,involving 22 system organ classifications.Tetracycline was concentrated in the gastrointestinal system and various nervous systems.Minocycline was mainly in the hepatobiliary system,endocrine system,and subcutaneous and subcu-taneous tissue diseases.Tigecycline was involved in the gastrointestinal system,systemic diseases and various reactive diseases at the administration site,Doxycycline was concentrated in the gastrointestinal system,mental illness,skin and subcutaneous tissue diseases.And it was found that psychosis was not involved in adverse reactions.Adverse reactions not included in the instructions include blindness and papilledema caused by minocycline,hypertriglyceridemia and acute pancreatitis caused by tigecycline,Bell's palsy,growth retardation,blindness,depression,suicidal thoughts and anxiety caused by doxycycline.Conclusions In different age groups of minor children,there are some differences in ADR among the four tetracycline drugs.ADR should be strictly monitored when using tetracycline drugs in all children.While paying attention to the effects of these drugs on children's teeth and bones,other ADE should also be vigilant,such as Jarisch-Herxheimer reaction,acne,thyroiditis,headache.The newly discovered involvement of systemic organs and AE can provide a reference for improving the adverse reactions of tetracycline-representative drugs to ensure the treatment safety of patients.
