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dc.contributor.authorBröms, Gabriella
dc.contributor.authorHernandez-Diaz, Sonia
dc.contributor.authorHuybrechts, Krista F.
dc.contributor.authorBateman, Brian T.
dc.contributor.authorKristiansen, Eskild Bendix
dc.contributor.authorEinarsdóttir, Kristjana
dc.contributor.authorEngeland, Anders
dc.contributor.authorFuru, Kari
dc.contributor.authorGissler, Mika
dc.contributor.authorKarlsson, Pär
dc.contributor.authorKlungsøyr, Kari
dc.contributor.authorLahesmaa-Korpinen, Anna-Maria
dc.contributor.authorMogun, Helen
dc.contributor.authorNørgaard, Mette
dc.contributor.authorReutfors, Johan
dc.contributor.authorSørensen, Henrik Toft
dc.contributor.authorZoega, Helga
dc.contributor.authorKieler, Helle
dc.date.accessioned2024-05-13T07:56:28Z
dc.date.available2024-05-13T07:56:28Z
dc.date.created2023-03-31T12:31:04Z
dc.date.issued2023
dc.identifier.issn0160-6689
dc.identifier.urihttps://hdl.handle.net/11250/3129997
dc.description.abstractObjective: Most research on safety of attention-deficit/ hyperactivity disorder (ADHD) medications during pregnancy concerns central nervous system stimulants, while little is known about the safety of atomoxetine, a primary treatment alternative. We assessed the prevalence of major congenital malformations overall, and cardiac malformations and limb malformations specifically, after first-trimester exposure. Methods: In this cohort study, we included all approximately 2.4 million pregnancies ending in live births recorded in the population-based nationwide health registers of Denmark, Iceland, Norway, and Sweden (2003–2017) and approximately 1.8 million publicly insured pregnancies ending in live births recorded in the US Medicaid Analytic eXtract (MAX, 2001–2013) health care claims database. We compared the prevalence of major congenital malformations in the newborn among pregnancies exposed and unexposed to atomoxetine. For each country, we calculated prevalence ratios (PRs), crude and stratified by propensity scores (PSs). We pooled the country-specific PS strata to obtain a PR adjusted for potential confounding factors. Results: We identified 368 pregnancies exposed to atomoxetine during the first trimester in the 4 Nordic countries and 622 in the US. The pooled crude PR for any major congenital malformation was 1.18 (95% CI, 0.88–1.60), and the adjusted PR was 0.99 (95% CI, 0.74–1.34). For cardiac malformations, the adjusted PR was 1.34 (95% CI, 0.86–2.09). For limb malformations, the adjusted PR was 0.90 (95% CI, 0.38–2.16). Conclusions: After atomoxetine exposure in early pregnancy, we observed no increase in major congenital malformations overall and, although with some uncertainty due to sample size, no statistically increased risk estimates for cardiac malformations and limb malformations.en_US
dc.language.isoengen_US
dc.publisherPhysicians Postgraduate Pressen_US
dc.rightsNavngivelse 4.0 Internasjonal*
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/deed.no*
dc.titleAtomoxetine in Early Pregnancy and the Prevalence of Major Congenital Malformations: A Multinational Studyen_US
dc.typeJournal articleen_US
dc.typePeer revieweden_US
dc.description.versionpublishedVersionen_US
dc.rights.holderCopyright 2023 The Author(s)en_US
dc.source.articlenumber22m14430en_US
cristin.ispublishedtrue
cristin.fulltextoriginal
cristin.qualitycode2
dc.identifier.doi10.4088/JCP.22m14430
dc.identifier.cristin2138850
dc.source.journalJournal of Clinical Psychiatryen_US
dc.relation.projectNorges forskningsråd: 262700en_US
dc.identifier.citationJournal of Clinical Psychiatry. 2023, 84 (1), 22m14430.en_US
dc.source.volume84en_US
dc.source.issue1en_US


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