Research on the association between tetracyclines use during pregnancy and congenital malformations in offspring
10.3760/cma.j.cn114015-20250303-00111
- VernacularTitle:妊娠期使用四环素类抗生素与子代先天畸形的相关性研究
- Author:
Jin GUO
1
;
Peng ZHAO
;
Chunrong LIU
;
Mingyu LIAO
;
Jingwen CHEN
;
Jianru WU
;
Yan REN
;
Biao RONG
;
Huanyang QI
;
Moliang CHEN
;
Xin SUN
;
Jing TAN
;
Yiquan XIONG
Author Information
1. 四川大学华西医院中国循证医学中心/国家药品监督管理局海南真实世界数据研究与评价重点实验室/四川省真实世界数据技术创新中心，成都 610041
- Publication Type:Journal Article
- Keywords:
Tetracyclines;
Pregnant women;
Congenital abnormalities;
Drug-related side effects and adverse reactions;
Adverse drug reaction reporting systems;
Cohort s
- From:
Adverse Drug Reactions Journal
2025;27(9):530-536
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the association between the use of tetracyclines during pregnancy and congenital malformations, with the aim of providing evidence-based guidance for the rational use of antibiotics during pregnancy.Methods:Data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) and the Canada Vigilance Adverse Reaction (CVAR) database from January 2015 to September 2024 were collected. Five methods including Tree-based scan statistic (TreeScan), proportional reporting ratio (PRR), reporting odds ratio (ROR), the UK Medicines and Healthcare Products Regulatory Agency (MHRA) comprehensive standard, and the Bayesian confidence propagation neural network (BCPNN) were used to detect signals of risk for congenital malformations in offspring following maternal use of tetracyclines during pregnancy. A signal that met the threshold criteria of all above 5 methods was considered as a risk signal. Based on population-based cohort of the drug exposures and adverse pregnancy outcomes (DEEP) data from January 2013 to December 2021 in Xiamen City, propensity score matching (PSM)-based Poisson regression was applied to evaluate the association between the first-trimester tetracyclines exposure and congenital malformations in offspring. Adjusted relative risk (a RR) and its 95% confidence interval ( CI) were calculated. Sensitivity analysis was conducted to validate the reliability of the results. Results:A total of 304 098 reports of adverse events during pregnancy were obtained from the FAERS and CVAR databases. Among them, 5 028 reports were related to tetracyclines, including 1 026 reports of congenital malformations in offspring, involving congenital malformations of musculoskeletal system, other digestive system, and other congenital malformations. Signal detection results suggested that tetracyclines may be a risk signal for above congenital malformations in offspring. The DEEP data included 411 936 pregnant women. After PSM, 240 pregnant women exposed to tetracyclines were included. The results showed no significant association between the first-trimester tetracyclines exposure and congenital malformations in offspring (a RR=0.75, 95% CI: 0.26-2.17), sensitivity analysis also showed no correlation. Conclusions:Data mining from the FAERS and CVAR databases suggests a potential association between tetracyclines use during pregnancy and congenital malformations in offspring. However, the DEEP data study shows no significant correlation.
