| アブストラクト | OBJECTIVES: This real-world study aimed to identify pharmacovigilance signals for congenital heart disease (CHD) associated with drugs exposure and to characterize the phenotypic spectrum of CHD adverse event reports. METHODS: Adverse event reports for drug potentially associated with CHD were collected from the US Food and Drug Administration Adverse Event Reporting System (FAERS) between January 2004 and September 2025. We used reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS) to detect pharmacovigilance signals. The Bonferroni correction was employed to adjust for multiple comparisons and to further confirm the robustness of the signals. RESULTS: We identified a total of 871 drugs with reported signals for CHD, of which 67 drugs met the criteria across all four disproportionality analysis methods. These drugs covered a wide range of categories, with nervous system agents and systemic antiinfectives being the most numerous. Further stratified analysis by therapeutic class revealed that antidepressive agents (n = 10,433), anti-epileptic agents (n = 2735), and antiemetics (n = 2364) showed a higher reported frequency. Among these groups, the spectrum of reported CHD events remained largely consistent, with atrial septal defect (ASD) and ventricular septal defect (VSD) being the most frequently reported adverse events. CONCLUSION: Through a comprehensive analysis of FAERS data, we identified pharmacovigilance signals for CHD associated with drug exposure and described the phenotypes of reported CHD events with suspected drug involvement. Our findings provide a valuable reference for hypothesis generation and future epidemiologic studies, and they support the ongoing pharmacovigilance of drug safety particularly during pregnancy. |
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| ジャーナル名 | American heart journal plus : cardiology research and practice |
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| Pubmed追加日 | 2026/9/18 |
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| 投稿者 | He, Chun-Lin; Zhang, Xiao-Nan; Zhao, Gui-Xin; Ma, Li-Jing; Feng, Rong; Liu, Yan-Hong |
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| 組織名 | Department of Obstetrics, Yunnan Maternal and Child Health Hospital, Kunming,;650051, China.;Department of Public Laboratory, The Third People's Hospital of Kunming, Kunming,;650041, China.;Department of Endocrinology, NHC Key Laboratory of Healthy Birth and Birth Defect;Prevention in Western China First People's Hospital of Yunnan Province, The;Affiliated Hospital of Kunming University of Science and Technology, Kunming,;650032, China.;Department of Endocrinology, First People's Hospital of Yunnan Province, National;Clinical Key Specialty Cultivation Project Platform for Endocrinology, Kunming,;Department of Pharmacy, Yunnan Maternal and Child Health Hospital, Kunming,;Department of Pharmacy, NHC Key Laboratory of Healthy Birth and Birth Defect;Prevention in Western China First People's Hospital of Yunnan Province, Kunming, |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42756676/ |
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