{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T18:58:16Z","timestamp":1790621896013,"version":"4.1.0"},"reference-count":51,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100000265","name":"Medical Research Council","doi-asserted-by":"publisher","award":["MR\/N013638\/1"],"award-info":[{"award-number":["MR\/N013638\/1"]}],"id":[{"id":"10.13039\/501100000265","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>Many women take medications during pregnancy. However, the risk to the fetus from most medications is uncertain. Congenital anomalies are one of the leading causes of infant death and contribute to long\u2010term disability. Signal detection methods can be used to systematically identify possible medication\u2013anomaly associations that require further investigation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Data on first trimester medication exposures in pregnancies with a congenital anomaly reported to 14 EUROmediCAT registries with a birth year of 2005\u20132018 were analysed. Case\u2010malformed disproportionality analysis identified medication\u2013anomaly signals using a disproportionality signal detection method. Identified signals were then compared to previous EUROmediCAT signal detection studies and ranked based on a proxy for the severity of impact at a population level using the number of estimated excess congenital anomaly cases within the exposed population and the average additional time in hospital over the first year of life. Generalized linear mixed models were used to assess confounding by birth year and registry within the top 20 ranked signals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>1611 medication\u2013outcome pairs with at least three observations were analysed, and 153 signals for 63 different medications were identified. Of the top 20 ranked signals, 10 (involving nine medications) were prioritized for further independent investigation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The signals identified here are hypothesis forming only. Independent studies that adequately account for confounding are subsequently needed to evaluate if the identified signals are causal. Further investigation of signals with low population impact, but high potential individual risk is also recommended.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bcp.70645","type":"journal-article","created":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T12:41:02Z","timestamp":1782909662000},"page":"3586-3597","source":"Crossref","is-referenced-by-count":0,"title":["Case\u2010malformed signal detection and prioritisation using EUROmediCAT data for pharmacovigilance in pregnancy"],"prefix":"10.1002","volume":"92","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3055-769X","authenticated-orcid":false,"given":"Hannah","family":"Johnson","sequence":"first","affiliation":[{"name":"City St George's (School of Health &amp; Medical Sciences)  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6639-5904","authenticated-orcid":false,"given":"Helen","family":"Dolk","sequence":"additional","affiliation":[{"name":"School of Medicine Ulster University  Londonderry UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1206-3637","authenticated-orcid":false,"given":"Maria","family":"Loane","sequence":"additional","affiliation":[{"name":"Institute of Nursing and Health Research Ulster University  Northern Ireland UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5018-0108","authenticated-orcid":false,"given":"Christine","family":"Damase\u2010Michel","sequence":"additional","affiliation":[{"name":"Facult\u00e9 de M\u00e9decine CERPOP UMR INSERM, Centre Hospitalier Universitaire Universit\u00e9 Toulouse  Toulouse France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4921-1944","authenticated-orcid":false,"given":"Joanne","family":"Given","sequence":"additional","affiliation":[{"name":"Institute of Nursing and Health Research Ulster University  Northern Ireland UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6361-2918","authenticated-orcid":false,"given":"Hedvig","family":"Nordeng","sequence":"additional","affiliation":[{"name":"Pharmacoepidemiology and Drug Safety Research Group, Department of Pharmacy, Faculty of Mathematics and Natural Sciences University of Oslo  Oslo Norway"},{"name":"Department of Child Health and Development Norwegian Institute of Public Health  Oslo Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3929-3619","authenticated-orcid":false,"given":"Jorieke E. 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