| アブストラクト | BACKGROUND: This study aimed to comprehensively analyze the adverse events associated with neuraminidase inhibitor (NAI) use in pregnant women in real-world clinical settings, providing a valuable reference for the management of anti-influenza treatment in this population. METHODS: The study extracted data from the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database, spanning from the first quarter of 2004 to the third quarter of 2025. Signal detection was performed using the reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN) methods. Adverse events (AEs) were classified according to the system organ class (SOC) in the Medical Dictionary for Regulatory Activities (MedDRA) version 27.0. RESULTS: From Q1 2004 to Q3 2025, a total of 3,687 ADE reports were retrieved in this study, including 3,211 reports for oseltamivir, 471 reports for zanamivir, and 5 reports for peramivir. For oseltamivir, significant AEs at SOCs were injury, poisoning, and procedural complications; pregnancy, puerperium, and perinatal conditions; and general disorders and administration site conditions. The five strongest AE signals were proctitis, infantile acne, congenital intestinal obstruction, no adverse event, and placental necrosis. For zanamivir, significant AEs at SOCs were injury, poisoning, and procedural complications; pregnancy, puerperium, and perinatal conditions; and respiratory, thoracic, and mediastinal disorders. The five strongest AE signals were delivery, bronchospasm, pneumothorax, exposure during pregnancy, and product quality issue. CONCLUSION: The study findings align with current guidelines recommending neuraminidase inhibitors as the primary antiviral treatment of pregnant women with influenza. Our study may offer valuable evidence to support the clinical use of neuraminidase inhibitors, particularly in identifying adverse events and ensuring their safe administration in women during pregnancy. |
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| 組織名 | Department of Pharmacy, Suzhou Ninth People's Hospital, Suzhou Ninth Hospital;Affiliated to Soochow University, Suzhou, Jiangsu, China.;Department of Rehabilitation, Suzhou Ninth People's Hospital, Suzhou Ninth;Hospital Affiliated to Soochow University, Suzhou, Jiangsu, China. |
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