Atomoxetine in Early Pregnancy and the Prevalence of Major Congenital Malformations:A Multinational Study
Objective: 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 malfor...
Published in: | The Journal of Clinical Psychiatry |
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2023
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Online Access: | https://pure.au.dk/portal/da/publications/atomoxetine-in-early-pregnancy-and-the-prevalence-of-major-congenital-malformations(4a6cb2d9-1e2b-4da0-81a8-4b2e5858e1b1).html https://doi.org/10.4088/JCP.22m14430 |
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ftuniaarhuspubl:oai:pure.atira.dk:publications/4a6cb2d9-1e2b-4da0-81a8-4b2e5858e1b1 2023-10-09T21:52:50+02:00 Atomoxetine in Early Pregnancy and the Prevalence of Major Congenital Malformations:A Multinational Study Bröms, Gabriella Hernandez-Diaz, Sonia Huybrechts, Krista F Bateman, Brian T Kristiansen, Eskild Bendix Einarsdóttir, Kristjana Engeland, Anders Furu, Kari Gissler, Mika Karlsson, Pär Klungsøyr, Kari Lahesmaa-Korpinen, Anna-Maria Mogun, Helen Nørgaard, Mette Reutfors, Johan Sørensen, Henrik Toft Zoega, Helga Kieler, Helle 2023-01 https://pure.au.dk/portal/da/publications/atomoxetine-in-early-pregnancy-and-the-prevalence-of-major-congenital-malformations(4a6cb2d9-1e2b-4da0-81a8-4b2e5858e1b1).html https://doi.org/10.4088/JCP.22m14430 eng eng info:eu-repo/semantics/openAccess Bröms , G , Hernandez-Diaz , S , Huybrechts , K F , Bateman , B T , Kristiansen , E B , Einarsdóttir , K , Engeland , A , Furu , K , Gissler , M , Karlsson , P , Klungsøyr , K , Lahesmaa-Korpinen , A-M , Mogun , H , Nørgaard , M , Reutfors , J , Sørensen , H T , Zoega , H & Kieler , H 2023 , ' Atomoxetine in Early Pregnancy and the Prevalence of Major Congenital Malformations : A Multinational Study ' , Journal of Clinical Psychiatry , vol. 84 , no. 1 , 22m14430 . https://doi.org/10.4088/JCP.22m14430 Pregnancy Infant Newborn Female Humans Atomoxetine Hydrochloride/adverse effects Cohort Studies Prevalence Abnormalities Drug-Induced/epidemiology Pregnancy Trimester First Heart Defects Congenital/chemically induced article 2023 ftuniaarhuspubl https://doi.org/10.4088/JCP.22m14430 2023-09-13T22:59:09Z Objective: 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. Article in Journal/Newspaper Iceland Aarhus University: Research Norway The Journal of Clinical Psychiatry 84 1 |
institution |
Open Polar |
collection |
Aarhus University: Research |
op_collection_id |
ftuniaarhuspubl |
language |
English |
topic |
Pregnancy Infant Newborn Female Humans Atomoxetine Hydrochloride/adverse effects Cohort Studies Prevalence Abnormalities Drug-Induced/epidemiology Pregnancy Trimester First Heart Defects Congenital/chemically induced |
spellingShingle |
Pregnancy Infant Newborn Female Humans Atomoxetine Hydrochloride/adverse effects Cohort Studies Prevalence Abnormalities Drug-Induced/epidemiology Pregnancy Trimester First Heart Defects Congenital/chemically induced Bröms, Gabriella Hernandez-Diaz, Sonia Huybrechts, Krista F Bateman, Brian T Kristiansen, Eskild Bendix Einarsdóttir, Kristjana Engeland, Anders Furu, Kari Gissler, Mika Karlsson, Pär Klungsøyr, Kari Lahesmaa-Korpinen, Anna-Maria Mogun, Helen Nørgaard, Mette Reutfors, Johan Sørensen, Henrik Toft Zoega, Helga Kieler, Helle Atomoxetine in Early Pregnancy and the Prevalence of Major Congenital Malformations:A Multinational Study |
topic_facet |
Pregnancy Infant Newborn Female Humans Atomoxetine Hydrochloride/adverse effects Cohort Studies Prevalence Abnormalities Drug-Induced/epidemiology Pregnancy Trimester First Heart Defects Congenital/chemically induced |
description |
Objective: 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. |
format |
Article in Journal/Newspaper |
author |
Bröms, Gabriella Hernandez-Diaz, Sonia Huybrechts, Krista F Bateman, Brian T Kristiansen, Eskild Bendix Einarsdóttir, Kristjana Engeland, Anders Furu, Kari Gissler, Mika Karlsson, Pär Klungsøyr, Kari Lahesmaa-Korpinen, Anna-Maria Mogun, Helen Nørgaard, Mette Reutfors, Johan Sørensen, Henrik Toft Zoega, Helga Kieler, Helle |
author_facet |
Bröms, Gabriella Hernandez-Diaz, Sonia Huybrechts, Krista F Bateman, Brian T Kristiansen, Eskild Bendix Einarsdóttir, Kristjana Engeland, Anders Furu, Kari Gissler, Mika Karlsson, Pär Klungsøyr, Kari Lahesmaa-Korpinen, Anna-Maria Mogun, Helen Nørgaard, Mette Reutfors, Johan Sørensen, Henrik Toft Zoega, Helga Kieler, Helle |
author_sort |
Bröms, Gabriella |
title |
Atomoxetine in Early Pregnancy and the Prevalence of Major Congenital Malformations:A Multinational Study |
title_short |
Atomoxetine in Early Pregnancy and the Prevalence of Major Congenital Malformations:A Multinational Study |
title_full |
Atomoxetine in Early Pregnancy and the Prevalence of Major Congenital Malformations:A Multinational Study |
title_fullStr |
Atomoxetine in Early Pregnancy and the Prevalence of Major Congenital Malformations:A Multinational Study |
title_full_unstemmed |
Atomoxetine in Early Pregnancy and the Prevalence of Major Congenital Malformations:A Multinational Study |
title_sort |
atomoxetine in early pregnancy and the prevalence of major congenital malformations:a multinational study |
publishDate |
2023 |
url |
https://pure.au.dk/portal/da/publications/atomoxetine-in-early-pregnancy-and-the-prevalence-of-major-congenital-malformations(4a6cb2d9-1e2b-4da0-81a8-4b2e5858e1b1).html https://doi.org/10.4088/JCP.22m14430 |
geographic |
Norway |
geographic_facet |
Norway |
genre |
Iceland |
genre_facet |
Iceland |
op_source |
Bröms , G , Hernandez-Diaz , S , Huybrechts , K F , Bateman , B T , Kristiansen , E B , Einarsdóttir , K , Engeland , A , Furu , K , Gissler , M , Karlsson , P , Klungsøyr , K , Lahesmaa-Korpinen , A-M , Mogun , H , Nørgaard , M , Reutfors , J , Sørensen , H T , Zoega , H & Kieler , H 2023 , ' Atomoxetine in Early Pregnancy and the Prevalence of Major Congenital Malformations : A Multinational Study ' , Journal of Clinical Psychiatry , vol. 84 , no. 1 , 22m14430 . https://doi.org/10.4088/JCP.22m14430 |
op_rights |
info:eu-repo/semantics/openAccess |
op_doi |
https://doi.org/10.4088/JCP.22m14430 |
container_title |
The Journal of Clinical Psychiatry |
container_volume |
84 |
container_issue |
1 |
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1779316025884409856 |