| アブストラクト | Background/Objectives: The increased incidence of obesity and type 2 diabetes, along with the growing use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs), particularly semaglutide, among women of childbearing age makes it especially important to assess their safety profile during pregnancy. Methods: A post-marketing study was conducted using reports from the U.S. FDA Adverse Event Reporting System (FAERS) database (2017-2025). Descriptive analyses focused on pregnancy outcomes and fetal/neonatal disorders. Disproportionality analyses assessed adverse event (AE) reporting by System Organ Class (SOC) and pregnancy-related AEs associated with semaglutide versus other medications. A Standardized MedDRA Query (SMQ)-based disproportionality analysis was also performed. Results: A total of 249 cases involving semaglutide use during pregnancy were identified, comprising 922 AEs. "Injury, poisoning and procedural complications" was the most frequently reported SOC, while abortion- and pregnancy loss-related events accounted for 27.3% of reported AEs. Compared with other medications, semaglutide showed higher reporting odds for "Pregnancy, puerperium and perinatal conditions" (ROR 1.59; 95% CI 1.37-1.86), "Injury, poisoning and procedural complications" (ROR 1.93; 95% CI 1.70-2.20), and gastrointestinal disorders (ROR 1.72; 95% CI 1.38-2.15), with no significant association for "Congenital, familial and genetic disorders" or "Reproductive system and breast disorders". SMQ-based analysis showed increased reporting odds for "Termination of pregnancy and risk of abortion" (ROR 3.71; 95% CI 3.07-4.48). Conclusions: Disproportionate reporting was identified for pregnancy- and perinatal-related events, procedural/exposure-related complications, and pregnancy termination, with no evidence of a disproportionate congenital-anomaly signal. These findings should be interpreted cautiously and do not necessarily indicate a causal association. |
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| ジャーナル名 | Pharmaceuticals (Basel, Switzerland) |
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| Pubmed追加日 | 2026/8/27 |
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| 投稿者 | Zinzi, Alessia; Gaio, Mario; Mascolo, Annamaria; Pieretti, Gorizio; Cipriani, Mattia; Della Ragione, Joao Marcos; D'Amato, Rossana; Rossi, Francesco; Capuano, Annalisa; Ruggiero, Rosanna |
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| 組織名 | Department of Life Sciences, Health, and Health Professions, Link Campus;University, 00198 Rome, Italy.;Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138;Naples, Italy.;Department of Experimental Medicine, Section of Pharmacology "L. Donatelli",;University of Campania "Luigi Vanvitelli", 80138 Naples, Italy.;Plastic Surgery Unit, University of Campania "Luigi Vanvitelli", 80138 Naples,;Italy.;Maternal and Child Care Unit, Local Health Authority (ASL), 84121 Salerno, Italy. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42653746/ |
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