Bisphosphonate use and pregnancy complications: Insights from the FDA adverse event reporting system (FAERS) database.
Bone, cilt.208, ss.117889, 2026 (SCI-Expanded, Scopus)
- Yayın Türü: Makale / Tam Makale
- Cilt numarası: 208
- Basım Tarihi: 2026
- Doi Numarası: 10.1016/j.bone.2026.117889
- Dergi Adı: Bone
- Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, BIOSIS, EMBASE, MEDLINE, Academic Search Ultimate (EBSCO)
- Sayfa Sayıları: ss.117889
- Anahtar Kelimeler: Bisphosphonate, Congenital anomaly, Fetal anomaly, Pregnancy complication
- İstanbul Üniversitesi Adresli: Evet
Özet
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 (ROR025 = 3.35), fetal disorders (ROR025 = 2.50), and pregnancy termination or abortion-related events (ROR025 = 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.