13 research outputs found

    Atomoxetine in Early Pregnancy and the Prevalence of Major Congenital Malformations : A Multinational Study

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    Funding Information: Submitted: February 18, 2022; accepted September 20, 2022. Published online: January 16, 2023. Relevant financial relationships: Dr Bröms has been a speaker for Takeda and has been involved in projects at Centre for Pharmacoepidemiology, Karolinska Institutet, partly financed by Janssen, Pfizer, and UCB, all unrelated to this project. Dr Hernandez-Diaz is an investigator on grants to her institution from Takeda for unrelated studies, has received personal consulting fees from UCB and Roche outside the submitted work, and has served as an epidemiologist with the North America AED pregnancy registry and as a scientific advisor for the National Pregnancy Registry for Psychiatric Medication and for Pregistry, which are funded by multiple companies. Dr Huybrechts reports being an investigator on research grants to her institution from Takeda and UCB for unrelated studies. Mr Karlsson is employed at the Centre for Pharmacoepidemiology, Karolinska Institutet, which receives grants from several entities (pharmaceutical companies, regulatory authorities, and contract research organizations) for performance of drug safety and drug utilization studies, with no relation to the work reported in this article. Dr Nørgaard is employed at the Department of Clinical Epidemiology, Aarhus University Hospital, which receives funding for other studies from companies in the form of research grants to (and administered by) Aarhus University. None of these studies has any relation to the present study. Dr Reutfors is employed at the Centre for Pharmacoepidemiology, Karolinska Institutet, which receives grants from several entities (pharmaceutical companies, regulatory authorities, and contract research organizations) for performance of drug safety and drug utilization studies, with no relation to the work reported in this article. Dr Sørensen is employed at the Department of Clinical Epidemiology, Aarhus University Hospital, which receives funding for other studies from companies in the form of research grants to (and administered by) Aarhus University. None of these studies have any relation to the present study. Dr Zoega is employed at the Centre for Big Data Research in Health, UNSW Sydney, which received funding from AbbVie Australia in 2020 to conduct research, unrelated to this study. AbbVie did not have any knowledge of, or involvement in, this study. Dr Kieler is employed at the Centre for Pharmacoepidemiology, Karolinska Institutet, which receives grants from several entities (pharmaceutical companies, regulatory authorities, and contract research organizations) for performance of drug safety and drug utilization studies, with no relation to the work reported in this article. Drs Bateman, Einarsdóttir, Engeland, Furu, Gissler, Klungsøyr, and Lahesmaa-Korpinen; Mr Kristiansen; and Ms Mogun report no conflicts of interest. Funding/support: This study was supported by the Söderström-König Foundation (SLS-664411); the Swedish Society of Medicine (SLS-689141); and the Stockholm Region (clinical postdoc appointment SLL-20170670); partly supported by the Research Council of Norway through its Centres of Excellence funding scheme (Project# 262700); NordForsk as part of the Nordic Pregnancy Drug Safety Studies (NorPreSS; Project# 83539); the Research Council of Norway as part of the International Pregnancy Drug Safety Studies (InPreSS; Project# 273366); UNSW Scientia Award (to H.Z.); The Drugs and Pregnancy project, funded by the Finnish Institute for Health and Welfare (THL), the Finnish Medicines Agency (FIMEA), and the Social Insurance Institution of Finland (Kela); the National Institute of Child Health and Human Development (R21 HD092879); and the National Institute of Mental Health (R01 MH116194). Role of the sponsor: The funding sources had no role in the design and conduct of the study or in the decision to publish. Previous presentation: An oral presentation of this work (title: ADHD Drugs During Pregnancy and the Risk of Congenital Malformations: A Study from the International Pregnancy Safety Study [InPreSS] Consortium) was made at the International Conference of Pharmacoepidemiology and Drug Safety; Montreal, Canada; August 26-30 2017. Ethical approval: The study was approved by the Regional Ethical Review Board in Stockholm, Sweden (2015/1826-31/2); the National Bioethics Committee in Iceland (VSNb201860017/03.01); the Steering Committee of the Drugs and Pregnancy Project; the Norwegian Data Inspectorate and the Regional Ethics Committee for Medical Research of South/East Norway); and the Danish Data Protection Agency (2015-57-0002). The use of the US data was approved by the Institutional Review Board of Brigham and Women’s Hospital, which granted a waiver of informed consent. Additional information: The data in this study were obtained from national health registers in Denmark, Iceland, Norway, and Sweden and the US Medicaid Analytic eXtract and cannot be made publicly available in their entirety due to national laws and data privacy. ORCID: Gabriella Bröms: https://orcid.org/0000-0002-2423-1968; Johan Reutfors: https://orcid. org/0000-0003-1372-4262; Mika Gissler: https:// orcid.org/0000-0001-8254-7525; Kari Klungsøyr: https://orcid.org/0000-0003-2482-1690; Mette Nørgaard: https://orcid.org/0000-0001-6110-5891; Anders Engeland: https://orcid.org/0000-0001-5620-9207; Anna-Maria Lahesmaa-Korpinen: https://orcid.org/0000-0003-1062-2893; Krista Huybrechts: https://orcid.org/0000-0001-5805-8430; Kari Furu: https://orcid.org/0000-0003-2245-0179; Kristjana Einarsdóttir: https://orcid.org/0000-0003-4931-7650; Henrik Toft Sørensen: https:// orcid.org/0000-0003-4299-7040; Helga Zoega: https://orcid.org/0000-0003-0761-9028 Supplementary material: Available at Psychiatrist.com. Publisher Copyright: © 2023 The Authors. Published by Physicians Postgraduate Press, Inc.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.Peer reviewe

    Recovery- oriented professionals: Helping relationships in mental health services

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    Kvalitativ studie med fokus på recovery.Studien baserte seg på intervju med 15 brukere. Resultatet av studien viser at recovery-orienterte fagfolk var de som hadde mot til å takle kompleksiteten og individualiteten i brukernes endringsprosesser, og som var i stand til å bruke sine faglige ferdigheter og kompetanse i et samarbeid med brukeren. En recovery- orientering blant fagfolk innebærer vilje og evne til å forme tjenester til de behov og preferanser som hver enkelt bruker har

    Recovery- oriented professionals: Helping relationships in mental health services

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    Studien baserte seg på intervju med 15 brukere. Resultatet av studien viser at recovery-orienterte fagfolk var de som hadde mot til å takle kompleksiteten og individualiteten i brukernes endringsprosesser, og som var i stand til å bruke sine faglige ferdigheter og kompetanse i et samarbeid med brukeren. En recovery- orientering blant fagfolk innebærer vilje og evne til å forme tjenester til de behov og preferanser som hver enkelt bruker har

    In memoriam: Wolf Wolfensberger (1934–2011)

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    20. Social integration in a welfare state: Research from Norway and Sweden

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    1 INTRODUCTION This chapter is concerned with research from Norway and Sweden about persons with developmental impairments and the services they receive. Most research has been related to national reform efforts, particularly in the field of mental retardation, and attempts to evaluate these reforms. Research has, however, not been limited to narrow evaluative questions, but also more fundamental ones about past and present aspirations and patterns, nature of social relations and welf..

    Living through exposure to toxic psychiatric orthodoxies: exploring narratives of people with 'mental health problems' who are looking for employment on the open labour market

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    This article explores lived experiences and insights of five people with long-term 'mental health problems', focusing on their search for employment in a disabling society. In our qualitative, inductive analysis we investigate why it seems almost impossible to attain a status as respected adult workers. We present five central findings: (1) losing the game before it starts; (2) internalizing the vicious circle of victim blaming; (3) from control overload to a life with inadequate supports; (4) from crushed dreams back to passive inactivity; (5) signs of resilience and resistance. In meaningful dialogue survivors give voice to alternative and plural epistemological grounds of life with 'madness'. In our concluding reflections we argue that psychiatric discourses, what we term toxic psychiatric orthodoxies, silence, disable and construct survivors as unemployable
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