| アブストラクト | PURPOSE: The sustained incorporation of bisphosphonates (BPs) into bone matrix, together with their documented transplacental transfer, raises concerns regarding their use in women of childbearing potential. We conducted a comprehensive evaluation of pregnancy-related adverse events (AEs) associated with BP exposure, utilizing data from the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). METHODS: AEs associated with BP exposure during pregnancy reported to the FAERS between 2004 and 2025 were analyzed. Disproportionality analyses were performed using four standard signal-detection methods: reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC), and empirical Bayesian geometric mean (EBGM). RESULTS: A total of 871 pregnancy-related AEs were identified. Alendronate accounted for the majority of exposures (n = 745). Pregnancy-related complications constituted the largest category of AEs (n = 751; 86%), followed by congenital, familial, and genetic disorders (n = 121; 14%), termination of pregnancy and risk of abortion (n = 40; 4.5%), and neonatal disorders (n = 39; 4.5%). AE reporting was higher with intravenous BPs than with oral agents, particularly for neonatal disorders (ROR(025) = 3.35), fetal disorders (ROR(025) = 2.50), and pregnancy termination or abortion-related events (ROR(025) = 2.37). CONCLUSION: BP exposure during pregnancy appears to be associated with an increased risk of pregnancy- and fetal-related complications. Intravenous agents showed higher reporting of pregnancy complications. |
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| ジャーナル名 | Bone |
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| Pubmed追加日 | 2026/4/9 |
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| 投稿者 | Yazdali Koylu, Nur; Esen, Bugra Han; Mutlu, Ummu; Hacisahinogullari, Hulya; Yenidunya Yalin, Gulsah; Kubat Uzum, Ayse |
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| 組織名 | Istanbul University, Istanbul Faculty of Medicine, Department of Internal;Medicine, Division of Endocrinology and Metabolism, Istanbul, Turkiye. Electronic;address: nuryazdalikoylu@istanbul.edu.tr.;Koc University School of Medicine, Istanbul, Turkiye.;Medicine, Division of Endocrinology and Metabolism, Istanbul, Turkiye. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/41951118/ |
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