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We evaluated VPA\u2010induced congenital disorder reports in EudraVigilance (EV), before and after the most recent EU risk minimization recommendations in 2018, and conducted a literature review of studies capturing pregnancy exposure data to VPA.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>EV public database of reports was searched for congenital ADRs for VPA, between Jan 2013 and Jun 2023. Descriptive analysis was performed to evaluate demographic data, year trends, outcomes, indications, and concomitant folic acid. A structured review of the literature based on explicit key words and eligibility criteria was conducted in PubMed and EU PAS Register (now HMA\u2010EMA Catalogue for RWD sources) to capture pregnancy exposure to VPA. Data on study design, objectives, and results, particularly pregnancy exposure, were extracted.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 2021 reports containing 3210 VPA\u2010induced congenital disorders were identified (2068 congenital malformations, 634 neural tube defects, 614 cardiac malformations). Most ages reported were between 0 and 1\u2009months (<jats:italic>n<\/jats:italic>, 387) and for the male sex (<jats:italic>n<\/jats:italic>, 833). Generally, the outcome was \u201cnot recovered\/not resolved,\u201d with 2.8% fatal ADRs reported. The number of reports slightly decreased through the years (lowest in 2015 [<jats:italic>n<\/jats:italic>, 154]; highest in 2013 [<jats:italic>n<\/jats:italic>, 669]). The literature review included 24 eligible studies, depicting varying levels of pregnancy exposure depending on the study aims and population, with an overall vast heterogeneity in presenting the study results.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The number of VPA\u2010induced congenital disorder reports slightly decreased. Despite absolute contraindications, pregnancy exposure to VPA continues to occur. The present analysis signals that VPA use during pregnancy is still an actual issue despite constant risk mitigation measures.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.70134","type":"journal-article","created":{"date-parts":[[2025,5,28]],"date-time":"2025-05-28T20:58:40Z","timestamp":1748465920000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Valproic Acid\u2010Induced Congenital Disorders, an Analysis in <scp>EudraVigilance<\/scp> and a Literature Review of Valproic Acid Utilization During Pregnancy"],"prefix":"10.1002","volume":"34","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6803-3683","authenticated-orcid":false,"given":"M\u0103d\u0103lina","family":"Hurub\u0103","sequence":"first","affiliation":[{"name":"Department of Pharmacology, Physiology and Physiopathology, Faculty of Pharmacy \u201cIuliu Ha\u0163ieganu\u201d University of Medicine and Pharmacy  Cluj\u2010Napoca Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2109-8409","authenticated-orcid":false,"given":"Andreea","family":"Farca\u0219","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Research Center \u201cIuliu Ha\u021bieganu\u201d University of Medicine and Pharmacy  Cluj\u2010Napoca Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Leucu\u021ba","sequence":"additional","affiliation":[{"name":"Department of Medical Informatics and Biostatistics \u201cIuliu Ha\u021bieganu\u201d University of Medicine and Pharmacy  Cluj\u2010Napoca Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cristina","family":"Mogo\u0219an","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Physiology and Physiopathology, Faculty of Pharmacy \u201cIuliu Ha\u0163ieganu\u201d University of Medicine and Pharmacy  Cluj\u2010Napoca Romania"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,5,28]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"European Medicines Agency \u201cValproate and Related Substances. 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