{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,13]],"date-time":"2026-05-13T16:24:07Z","timestamp":1778689447899,"version":"3.51.4"},"reference-count":28,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2025,2,16]],"date-time":"2025-02-16T00:00:00Z","timestamp":1739664000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"published-print":{"date-parts":[[2025,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aims<\/jats:title><jats:p>The aim of this study was to assess the risk of major congenital malformations following first\u2010trimester pseudoephedrine (PSE) exposure.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A population\u2010based observational cohort study was conducted on pregnancies of women aged 15\u201349\u2009years, insured by Clalit Health Services in southern Israel, who gave birth or had elective pregnancy terminations due to suspected fetal malformation at Soroka Medical Center (1999\u20132017). The study focused on Clarinase, a drug that contains a high dose of PSE (120\u2009mg) and 5\u2009mg of loratadine. Multivariable negative binomial regression models were used to evaluate the risk for major congenital malformations, adjusting for potential confounders.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 251\u2009543 pregnancies, 313 (0.12%) were exposed to high\u2010dose PSE in the first trimester. PSE exposure was not associated with major congenital malformations overall (adjusted relative risk [aRR]\u2009=\u20090.90, 95% confidence interval [CI] 0.558\u20131.45; <jats:italic>P<\/jats:italic>\u2009=\u20090.66) or by organ system (cardiovascular: aRR\u2009=\u20090.938, 95% CI 0.499\u20131.762; central nervous system: aRR\u2009=\u20090.618, 95% CI 0.086\u20134.451; musculoskeletal: aRR\u2009=\u20091.800, 95% CI 0.801\u20134.042; gastrointestinal: aRR\u2009=\u20091.013, 95% CI 0.142\u20137.241; genitourinary: aRR\u2009=\u20090.704, 95% CI 0.225\u20132.204).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>First\u2010trimester PSE exposure was not an independent risk factor for major congenital malformations, either overall or by organ system.<\/jats:p><\/jats:sec>","DOI":"10.1002\/bcp.70001","type":"journal-article","created":{"date-parts":[[2025,2,17]],"date-time":"2025-02-17T00:14:37Z","timestamp":1739751277000},"page":"1834-1841","source":"Crossref","is-referenced-by-count":2,"title":["Exposure to pseudoephedrine during pregnancy and major congenital malformations: Findings from a large population\u2010based cohort of pregnancies"],"prefix":"10.1002","volume":"91","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-9362-1484","authenticated-orcid":false,"given":"Saar","family":"Dor","sequence":"first","affiliation":[{"name":"Department of Epidemiology, Biostatistics, and Community Health Sciences, School of Public Health Ben\u2010Gurion University of the Negev  Beer\u2010Sheva Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tal","family":"Michael","sequence":"additional","affiliation":[{"name":"Department of Epidemiology, Biostatistics, and Community Health Sciences, School of Public Health Ben\u2010Gurion University of the Negev  Beer\u2010Sheva Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-3412-5297","authenticated-orcid":false,"given":"Yael","family":"Levi","sequence":"additional","affiliation":[{"name":"Department of Epidemiology, Biostatistics, and Community Health Sciences, School of Public Health Ben\u2010Gurion University of the Negev  Beer\u2010Sheva Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gali","family":"Pariente","sequence":"additional","affiliation":[{"name":"Obstetrics and Gynecology, Faculty of Health Sciences Ben\u2010Gurion University of the Negev  Beer\u2010Sheva Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eitan","family":"Lunenfeld","sequence":"additional","affiliation":[{"name":"Adelson School of Medicine Ariel University  Ariel Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amalia","family":"Levy","sequence":"additional","affiliation":[{"name":"Department of Epidemiology, Biostatistics, and Community Health Sciences, School of Public Health Ben\u2010Gurion University of the Negev  Beer\u2010Sheva Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shira","family":"Birenstock\u2010Cohen","sequence":"additional","affiliation":[{"name":"Department of Social Services Soroka University Medical Center  Beer Sheva Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1820-9278","authenticated-orcid":false,"given":"Sharon","family":"Daniel","sequence":"additional","affiliation":[{"name":"Department of Epidemiology, Biostatistics, and Community Health Sciences, School of Public Health Ben\u2010Gurion University of the Negev  Beer\u2010Sheva Israel"},{"name":"Department of Pediatrics Ben\u2010Gurion University of the Negev  Beer\u2010Sheva Israel"},{"name":"Clalit Health Services, Southern District  Beer\u2010Sheva Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,2,16]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms22105146"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/j.1875\u20109114.1993.tb02779.x"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365\u20102125.2000.00252.x"},{"key":"e_1_2_11_5_1","unstructured":"Lexicomp. 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