Antipsychotic use during pregnancy and risk of specific neurodevelopmental disorders and learning difficulties in children: a multinational cohort study.

Autor:	Bruno C; School of Population Health, Faculty of Medicine and Health, University of New South Wales, Sydney, Australia.; Department of Chronic Diseases, Norwegian Institute of Public Health, Oslo, Norway., Cesta CE; Centre for Pharmacoepidemiology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden., Hjellvik V; Department of Chronic Diseases, Norwegian Institute of Public Health, Oslo, Norway., Ulrichsen SP; Department of Clinical Epidemiology, Department of Clinical Medicine, Aarhus University and Aarhus University Hospital, Aarhus, Denmark., Bjørk MH; Department of Clinical Medicine, University of Bergen, Bergen, Norway.; Department of Neurology, Haukeland University Hospital, Bergen, Norway., Esen BÖ; Department of Clinical Epidemiology, Department of Clinical Medicine, Aarhus University and Aarhus University Hospital, Aarhus, Denmark., Gillies MB; School of Population Health, Faculty of Medicine and Health, University of New South Wales, Sydney, Australia., Gissler M; Knowledge Brokers, Finnish Institute for Health and Welfare, Helsinki, Finland.; Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.; Research Centre for Child Psychiatry, University of Turku, Turku, Finland., Havard A; School of Population Health, Faculty of Medicine and Health, University of New South Wales, Sydney, Australia.; National Drug and Alcohol Research Centre, Faculty of Medicine and Health, University of New South Wales, Sydney, Australia., Karlstad Ø; Department of Chronic Diseases, Norwegian Institute of Public Health, Oslo, Norway., Leinonen MK; Knowledge Brokers, Finnish Institute for Health and Welfare, Helsinki, Finland., Nørgaard M; Department of Clinical Epidemiology, Department of Clinical Medicine, Aarhus University and Aarhus University Hospital, Aarhus, Denmark., Pearson SA; School of Population Health, Faculty of Medicine and Health, University of New South Wales, Sydney, Australia., Reutfors J; Centre for Pharmacoepidemiology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden., Furu K; Department of Chronic Diseases, Norwegian Institute of Public Health, Oslo, Norway.; Centre for Fertility and Health, Norwegian Institute of Public Health, Oslo, Norway., Cohen JM; Department of Chronic Diseases, Norwegian Institute of Public Health, Oslo, Norway.; Centre for Fertility and Health, Norwegian Institute of Public Health, Oslo, Norway., Zoega H; School of Population Health, Faculty of Medicine and Health, University of New South Wales, Sydney, Australia.; Centre of Public Health Sciences, Faculty of Medicine, University of Iceland, Reykjavik, Iceland.
Jazyk:	angličtina
Zdroj:	EClinicalMedicine [EClinicalMedicine] 2024 Mar 17; Vol. 70, pp. 102531. Date of Electronic Publication: 2024 Mar 17 (Print Publication: 2024).
DOI:	10.1016/j.eclinm.2024.102531
Abstrakt:	Background: Antipsychotics are commonly prescribed to treat a range of psychiatric conditions in women of reproductive age and during pregnancy, including schizophrenia, bipolar disorder, anxiety, depression, autism spectrum disorder, and insomnia. This study aimed to evaluate whether children exposed to antipsychotic medication prenatally are at increased risk of specific neurodevelopmental disorders and learning difficulties. Methods: Our population-based cohort study used nationwide register data (1 January 2000-31 December 2020) on pregnant women diagnosed with a psychiatric disorder and their live-born singletons from Denmark, Finland, Iceland, Norway, and Sweden. Cox proportional hazard regression yielded propensity score-weighted hazard ratios (aHRs) and 95% confidence intervals (CIs) for risk of intellectual-, speech or language-, learning-developmental disorders, and a composite outcome of the listed disorders. We defined poor performance as scoring within the lowest quartile on national school tests in mathematics and language arts. We estimated propensity score-weighted risk ratios (aRRs) using Poisson regression. We analysed data from Denmark separately and pooled results using random effects meta-analysis. Findings: Among 213,302 children (median follow-up: 6.7 years), 11 626 (5.5%) were exposed to antipsychotics prenatally. Adjusted risk estimates did not suggest an increased risk of neurodevelopmental disorders: aHR of 1.06 (95% CI 0.94-1.20) for the composite outcome, or for poor academic performance: aRR of 1.04 (95% CI 0.91-1.18) in mathematics, and of 1.00 (95% CI 0.87-1.15) in language arts. Results were generally consistent across individual medications, trimesters of exposure, sibling- and sensitivity analyses. Interpretation: The findings of this large multinational cohort study suggest there is little to no increased risk of child neurodevelopmental disorders or learning difficulties after prenatal exposure to antipsychotics. Our findings can assist clinicians and women managing mental illness during pregnancy. Funding: This study was funded by the NordForsk Nordic Program on Health and Welfare (Nordic Pregnancy Drug Safety Studies, project No. 83539), by the Research Council of Norway (International Pregnancy Drug Safety Studies, project No. 273366) and by the Research Council of Norway through its Centres of Excellence funding scheme (project No. 262700), and UNSW Scientia Programme Awards (PS46019, PS46019-A). Competing Interests: CEC and JR are employees of the Centre for Pharmacoepidemiology at Karolinska Institutet, which receives funding from several entities (pharmaceutical companies, regulatory authorities, contract research organizations) for the performance of drug safety and drug utilization studies, unrelated to this work. KF, ØK, and VH report participation in regulator mandated phase IV studies (PASS) unrelated to the submitted work, funded by pharmaceutical companies (Novo Nordisk, LEO Pharma and Bristol Myers Squibb) and paid to the institution (no personal fees). MG and MKL Leinonen report a grant from the Innovative Medicines Initiative (IMI ConcePTION, grant agreement number 821520) while conducting the study, unrelated to this work. MG and MKL also report that their institution has received funding from pharmaceutical companies to conduct regulator mandated post-marketing drug safety research outside the submitted work. MHB reported fees paid to her institution by valproate market authorization holders for EMA-mandated contract research (PASS studies); speaking and/or consultancy honoraria from Eisai, Novartis Norway, Jazz Pharmaceuticals, Angelini Pharma, AbbVie, Teva, Lilly, and Lundbeck unrelated to the medications in the study. All other authors do not report any competing interests. (© 2024 The Authors.)
Databáze:	MEDLINE
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