机构:[1]School of Pharmaceutical Sciences, Jinan University, Guangzhou, Guangdong Province, China.[2]Medical Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China.广东省中医院[3]Medical Department, Xiong'an Xuanwu Hospital, Rongcheng, Hebei Province, China.首都医科大学宣武医院
Cardiovascular drugs can cross the placenta during pregnancy, potentially exposing the fetus to teratogenic effects. However, ethical constraints on clinical trials with pregnant women limit safety data and result in inadequate drug labeling.Using the FAERS database (2004-2023), we conducted a retrospective pharmacovigilance study analyzing adverse event reports involving congenital anomalies in newborns (<28 days). Signal detection methods included Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). Our analysis concentrated on the systems or organs involved in the signals, particularly those with higher report counts or signal values, to explore the association between drugs and congenital abnormalities.Among 6,208 cases of congenital anomalies in newborns, 387 were linked to cardiovascular drugs, generating 97 signals for 16 drugs. Strong signals included sartans (renal failure, skeletal deformity), metoprolol (hypospadias, large-for-dates baby), amlodipine (gastrointestinal malformations), and statins, furosemide, and spironolactone (dysmorphism).Enhanced monitoring is recommended for fetal malformations in women exposed to these drugs before or during pregnancy. While our findings suggest associations, they do not establish causality, highlighting the need for further research to ensure medication safety during pregnancy.
第一作者机构:[1]School of Pharmaceutical Sciences, Jinan University, Guangzhou, Guangdong Province, China.
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推荐引用方式(GB/T 7714):
Zheng Jingping,Ma Lin,Zhang Zhenpo,et al.Congenital anomalies associated with the use of cardiovascular drugs during pregnancy: a large-scale data analysis from the FAERS database[J].Expert Opinion On Drug Safety.2025,24(2):193-199.doi:10.1080/14740338.2024.2442519.
APA:
Zheng Jingping,Ma Lin,Zhang Zhenpo,Liang Yankun,Din Chufeng...&Su Ling.(2025).Congenital anomalies associated with the use of cardiovascular drugs during pregnancy: a large-scale data analysis from the FAERS database.Expert Opinion On Drug Safety,24,(2)
MLA:
Zheng Jingping,et al."Congenital anomalies associated with the use of cardiovascular drugs during pregnancy: a large-scale data analysis from the FAERS database".Expert Opinion On Drug Safety 24..2(2025):193-199