Drug toxicities of nifedipine in pregnant women with hypertension: a real-world study based on FARES database
10.12206/j.issn.2097-2024.202501001
- VernacularTitle:硝苯地平在高血压孕妇中的药物毒性：基于FARES数据库的真实世界研究
- Author:
Jianfang JIANG
1
;
Siping WANG
2
;
Xinjun HE
1
Author Information
1. Hangzhou Third People' s Hospital,Hangzhou 310009, China.
2. Hangzhou First People’s Hospital Tonglu Branch, Hangzhou 311599, China.
- Publication Type:Medicine&Clinical
- Keywords:
nifedipine;
information component;
reporting odds ratio;
hypertension;
pregnant women;
adverse drug events
- From:
Journal of Pharmaceutical Practice and Service
2025;43(6):307-312
- CountryChina
- Language:Chinese
-
Abstract:
Objective To systematically evaluate toxicities of nifedipine in pregnant women with hypertension, and provide references for nifedipine’s clinical safety application. Methods Study was conducted with data from US food and drug administration adverse event reporting system（FARES） database from January 1, 2015, to March 31, 2021. Information component （IC） and reporting odds ratio（ROR）methods were applied for signal mining. Results Finally, a total of 539278 records of pregnant women with hypertension were selected for analysis, and 70 positive adverse drug event signals were detected. Premature delivery （IC025=2.87，ROR025=9.52）, pre-eclampsia （IC025=1.82，ROR025=3.82） and fetal growth restriction （IC025=2.37，ROR025=5.69）were positive adverse events with higher frequency. Polydactyly（IC025=3.13， ROR025=10.05）, fetal death（IC025=2.93，ROR025=8.57）and premature delivery（IC025=2.87，ROR025=9.52）were positive adverse events with higher intensity. Vascular resistance systemic increased, small for dates baby and fetal death corresponded to higher death rates. Conclusion Nifedipine-associated drug toxicities were detected in pregnant women with hypertension, and some adverse events with high frequency and high death rate were deserved further attention by medical staffs.
