{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,10]],"date-time":"2026-06-10T23:58:35Z","timestamp":1781135915069,"version":"3.54.1"},"reference-count":37,"publisher":"Georg Thieme Verlag KG","issue":"03","license":[{"start":{"date-parts":[[2025,12,22]],"date-time":"2025-12-22T00:00:00Z","timestamp":1766361600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Z Geburtshilfe Neonatol"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>This study aimed to systematically characterize the features and drug\n                        distribution of neonatal adverse drug reactions using data from the FAERS,\n                        with a focus on exposure-specific patterns and stratified analyses by sex\n                        and clinical outcomes.<\/jats:p>\n                  <jats:p>Reports submitted to FAERS from the first quarter of 2004 to the fourth\n                        quarter of 2024 were utilized. Patients experienced the ADR at an age of no\n                        more than 28 days. Four quantitative disproportionality analysis methods,\n                        including ROR, PRR, BCPNN, and MGPS, were used to detect signals of adverse\n                        drug events.<\/jats:p>\n                  <jats:p>A total of 15,456 neonatal cases exposed to the target drugs were included,\n                        yielding 60,611 adverse event reports, 95.45% of which were classified as\n                        serious. The median time to onset of ADRs was 264 days for intrauterine drug\n                        exposure, compared to 1\u20133 days for extrauterine exposure. The most affected\n                        SOCs were injury and procedural complications (19.53%), congenital disorders\n                        (15.96%), and pregnancy\/perinatal conditions (8.65%). Transplacental\n                        exposure accounted for the highest proportion (52.47%), followed by\n                        intravenous (9.34%), oral (6.77%), breastfeeding (1.80%), intramuscular\n                        (1.48%), and inhalation (1.29%). The top maternal exposure drugs included\n                        venlafaxine, sertraline, quetiapine, lamotrigine, and levetiracetam. For\n                        intravenous use, levetiracetam, zidovudine, indomethacin, ibuprofen, and\n                        vancomycin were most common. Female neonates had higher risks of\n                        microcephaly, ventricular septal defect, and growth restriction, while male\n                        neonates were more prone to hypospadias, cryptorchidism, and agitation.\n                        Serious AEs were mainly linked to maternal drug exposure during\n                        pregnancy.<\/jats:p>\n                  <jats:p>These results showed that the use of antidepressants, antiepileptics, and\n                        antivirals during pregnancy represents a significant risk factor for\n                        neonatal adverse reactions, particularly congenital malformations.\n                        Consequently, it is imperative to implement precise prevention strategies\n                        tailored to specific exposure stages and to advocate for the establishment\n                        of an international pharmacovigilance network for neonates.<\/jats:p>","DOI":"10.1055\/a-2767-2466","type":"journal-article","created":{"date-parts":[[2025,12,22]],"date-time":"2025-12-22T23:42:58Z","timestamp":1766446978000},"page":"209-221","source":"Crossref","is-referenced-by-count":1,"title":["Differential Analysis of Neonatal Adverse Drug Events from\n                    Intrauterine and Extrauterine Exposure: Insights into Administration Routes\n                    Using the FAERS Database"],"prefix":"10.1055","volume":"230","author":[{"given":"Zhuqing","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Jinan Maternity and Child Care\n                    Hospital Affiliated to Shandong First Medical University, Jinan,\n                    China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meng","family":"Hou","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Jinan Maternity and Child Care\n                    Hospital Affiliated to Shandong First Medical University, Jinan,\n                    China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tingting","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Jinan Maternity and Child Care\n                    Hospital Affiliated to Shandong First Medical University, Jinan,\n                    China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"194","published-online":{"date-parts":[[2025,12,22]]},"reference":[{"key":"ref1"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.1242\/dmm.049065","article-title":"The benefits, limitations and opportunities of preclinical models for neonatal\n                    drug development","volume":"15","author":"S Campion","year":"2022","journal-title":"Dis Model Mech"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"669","DOI":"10.1007\/s00228-021-03267-x","article-title":"Drug utilisation in neonatal units in England and Wales: a national cohort\n            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intensive care settings: A systematic review","volume":"42","author":"A A Alghamdi","year":"2019","journal-title":"Drug Saf"},{"key":"ref7","doi-asserted-by":"crossref","first-page":"807","DOI":"10.1586\/17512433.2014.956090","article-title":"Adverse drug reactions in neonates: could we be documenting more?","volume":"7","author":"D B Hawcutt","year":"2014","journal-title":"Expert Rev Clin Pharmacol"},{"key":"ref8","doi-asserted-by":"publisher","first-page":"2506","DOI":"10.1016\/j.jaip.2024.05.042","article-title":"Pediatric drug-induced anaphylaxis reports in the FDA Adverse Event Reporting\n                    System (FAERS)","volume":"12","author":"A Brameli","year":"2024","journal-title":"J Allergy Clin Immunol Pract"},{"key":"ref9","doi-asserted-by":"publisher","first-page":"190","DOI":"10.2174\/1574886317666220404105653","article-title":"Pattern of adverse drug reactions among pregnant women and pediatric patients in\n                    a tertiary care 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