{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,8]],"date-time":"2026-06-08T03:59:45Z","timestamp":1780891185491,"version":"3.54.1"},"reference-count":69,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2026,3,11]],"date-time":"2026-03-11T00:00:00Z","timestamp":1773187200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,3,11]],"date-time":"2026-03-11T00:00:00Z","timestamp":1773187200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100003478","name":"Ministry of Health, Labour and Welfare","doi-asserted-by":"publisher","award":["H23\u2010iyaku\u2010ippan\u2010006"],"award-info":[{"award-number":["H23\u2010iyaku\u2010ippan\u2010006"]}],"id":[{"id":"10.13039\/501100003478","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bpspubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacology Res &amp; Perspec"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>This study aimed to evaluate the risk of major congenital malformations (MCMs) associated with first\u2010trimester exposure to antipsychotics, using a large claims database in Japan. This retrospective cohort study was based on data from a large claims database in Japan. We used a large claims database from 2010 to 2019. Dates of pregnancy onset and delivery were estimated using the developed algorithms. Overall MCMs were defined according to the International Classification of Diseases, 10th revision codes. To address confounding by indication, the risk of MCM in relation to first\u2010trimester antipsychotic use was evaluated among pregnant women with psychiatric disorders diagnosed before the end of the first\u2010trimester. We compared the prevalence of MCMs among infants born to pregnant women with or without first\u2010trimester exposure to antipsychotics and estimated the weighted odds ratios (wORs) using propensity\u2010score overlap weights. The prevalence of psychiatric diagnoses before the end of the first\u2010trimester was 6291 women among the 91\u2009390 who delivered between 2010 and 2019. Among the 6291 diagnosed with psychiatric disorders, 317 were exposed to any antipsychotics during the first\u2010trimester of pregnancy. The prevalence of overall MCMs among live births was 411 (6.9%) among women unexposed to any antipsychotics and 24 (7.6%) among those exposed. The first\u2010trimester exposure to any antipsychotics was not significantly associated with overall MCMs when wORs were calculated using propensity\u2010score overlap weights (wOR 1.144, 95% confidence intervals 0.727\u20131.799). Exposure to any antipsychotics during the first\u2010trimester of pregnancy was not associated with an increased risk of overall MCMs in infants.<\/jats:p>","DOI":"10.1002\/prp2.70231","type":"journal-article","created":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T05:45:14Z","timestamp":1773294314000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Risk of Major Congenital Malformations Associated With the First\u2010Trimester Exposure to Antipsychotics: A Large Claims Database Study"],"prefix":"10.1002","volume":"14","author":[{"given":"Ryo","family":"Obara","sequence":"first","affiliation":[{"name":"Division of Molecular Epidemiology, Graduate School of Medicine Tohoku University  Sendai Miyagi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9086-6999","authenticated-orcid":false,"given":"Takamasa","family":"Sakai","sequence":"additional","affiliation":[{"name":"Drug Informatics, Faculty of Pharmacy Meijo University  Nagoya Aichi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomofumi","family":"Ishikawa","sequence":"additional","affiliation":[{"name":"Laboratory of Biomolecule and Pathophysiological Chemistry, Graduate School of Pharmaceutical Sciences Tohoku University  Sendai Miyagi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kei","family":"Morishita","sequence":"additional","affiliation":[{"name":"Division of Molecular Epidemiology, Graduate School of Medicine Tohoku University  Sendai Miyagi Japan"},{"name":"Department of Pharmaceutical Sciences Tohoku University Hospital  Sendai Miyagi Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4277-4509","authenticated-orcid":false,"given":"Motohiko","family":"Adomi","sequence":"additional","affiliation":[{"name":"Department of Epidemiology Harvard T.H. 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