@article{Ljung2025,

title = {SARS-CoV-2 vaccination and myositis in Norway and Sweden},

author = {Rickard Ljung and Nicklas Pihlström and Jesper Dahl and German Tapia and Anders Sundström and Marja-Leena Nurminen and Ingrid E Lundberg and Øystein Karlstad and Marie Holmqvist and Nils Feltelius},

doi = {10.1093/rheumatology/keaf609},

issn = {1462-0332},

year  = {2026},

date = {2026-02-04},

volume = {65},

number = {2},

publisher = {Oxford University Press (OUP)},

abstract = {Abstract

                  

                    Objective

                    The objective of this study was to characterize the risk of myositis after Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination with messenger ribonucleic acid (mRNA) or adenoviral vector vaccines.

                  

                  

                    Methods

                    We conducted a population-based cohort study in Norway and Sweden of 13 million persons who turned 12 years or older in 2021 and were residents at the start of follow-up on 27 December 2020. The participants were followed until incident diagnosis of myositis, censoring, or the end of the study (21 May 2023). We used Poisson regression to estimate incidence rate ratios (IRRs) with 95% CIs, comparing rates in risk periods (day 0 up to and including day 180 after each dose) with rates in unvaccinated periods. Corrections for potential confounding were made by adjusting for sex, age, occupation (health-care worker), region, positive COVID-19 test, and comorbidities.

                  

                  

                    Results

                    We observed 101 myositis events in 7 002 398 unvaccinated person-years and 99 myositis events within 180 days of any combination of mRNA vaccines (6 241 529 person-years), and 13 with the adenoviral vector vaccine (445 256 person-years). The adjusted IRRs for the 180-day risk periods following any combination of mRNA vaccines and the adenoviral vector vaccine were 0.84 (95% CI, 0.63–1.11) and 1.31 (0.72–2.36), respectively, compared with unvaccinated periods. The estimates for each specific first, second and third dose of mRNA were similar to the estimate of all doses combined.

                  

                  

                    Conclusion

                    In this nationwide study of >13.6 million person-years in two countries, there were no signs of an increased risk of myositis after SARS-CoV-2 vaccination, neither after the mRNA vaccines nor after the adenoviral vector vaccine.

                  },

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Robijn2025,

title = {Effectiveness of smoking cessation pharmacotherapies during pregnancy: A multi‐national population‐based study},

author = {Annelies L. Robijn and Sarah Donald and Jacqueline M. Cohen and Duong T. Tran and Carolyn E. Cesta and Kari Furu and Lianne Parkin and Sallie‐Anne Pearson and Johan Reutfors and Helga Zoega and Nicholas Zwar and Alys Havard},

doi = {10.1111/add.70290},

issn = {1360-0443},

year  = {2025},

date = {2025-12-22},

journal = {Addiction},

publisher = {Wiley},

abstract = {Abstract

                  

                    Aims

                    As clinical trial evidence on the effectiveness of smoking cessation pharmacotherapies during pregnancy is inconclusive, we conducted a large cohort study examining their effectiveness and comparative effectiveness during pregnancy.

                  

                  

                    Design

                    Population‐based cohort study. We used propensity score matching and conditional Poisson regression to compare pharmacotherapy‐exposed with unexposed pregnancies, and to compare varenicline‐exposed with nicotine replacement therapy (NRT) ‐exposed pregnancies.

                  

                  

                    Setting

                    Birth records (2005–2020) from New South Wales (NSW) Australia, New Zealand (NZ) and Norway/Sweden linked to pharmacotherapy dispensing records.

                  

                  

                    Participants/cases

                    Women with a birth record indicating smoking in early pregnancy [during first 20 weeks' gestation (NSW), at lead maternity registration (NZ) or during the first trimester (Norway/Sweden)]. Participants were dispensed prescription NRT, varenicline or bupropion in the first 18 weeks of gestation (NSW, Norway/Sweden) or between the first antenatal visit and childbirth (NZ).

                  

                  

                    Measurements

                    We defined smoking cessation as not smoking after gestational week 20 (NSW), at gestational week 32–36 (Norway/Sweden) and at two weeks postpartum (NZ), identified via self‐report and documented in the birth record.

                  

                  

                    Findings

                    Our NRT analyses included 623, 7074 and 70 exposed and 6026, 68 161 and 700 propensity‐score‐matched unexposed pregnancies from NSW, NZ and Norway/Sweden, respectively. The associations between NRT and smoking cessation were mixed but tended toward reduced cessation compared with no pharmacotherapy. In NSW, NRT was associated with a reduction in cessation [relative risk (RR) = 0.68, 95% confidence interval (CI) = 0.48–0.97], while in NZ, the effect was smaller (RR = 0.93, 95% CI = 0.89–0.98) but inconclusive in Norway/Sweden (RR = 0.91, 95% CI = 0.61–1.35). Smoking cessation was also equally or less common among varenicline‐exposed pregnancies (NSW: 308 exposed vs 3077 matched unexposed, RR = 0.89, 95% CI = 0.72–1.09, Norway/Sweden: 196 exposed vs 1960 matched unexposed, RR = 0.49, 95% CI = 0.34–0.70). Our comparison of varenicline‐exposed with NRT‐exposed pregnancies indicated increased smoking cessation among varenicline‐exposed pregnancies (NSW: 108 vs 154 exposed, RR = 1.91, 95% CI = 1.10–3.22). There were too few bupropion‐exposed pregnancies to support interpretation.

                  

                  

                    Conclusions

                    Varenicline appears to be more effective at smoking cessation than nicotine replacement therapy during pregnancy. The uncertainty about the real‐world effectiveness of nicotine replacement therapy and bupropion remains as this study's analyses were impacted by non‐adherence and biased by unmeasured confounding.

                  },

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Refsum2025,

title = {Topical retinoid use in women of reproductive age and risk of major congenital malformations in exposed pregnancies: a Nordic cohort study},

author = {Erle Refsum and Kari Furu and Carolyn E Cesta and Mette Nørgaard and Felix Wittström and Helga Zoega and Sinna P Ulrichsen and Jacqueline M Cohen},

doi = {10.1093/bjd/ljaf500},

issn = {1365-2133},

year  = {2025},

date = {2025-12-09},

publisher = {Oxford University Press (OUP)},

abstract = {Abstract

                  

                    Background

                    Topical retinoids are used to treat mild to moderate acne and should be avoided during pregnancy as a precaution given the teratogenic effect of systemic isotretinoin, despite limited safety data.

                  

                  

                    Objectives

                    To describe recent trends in the prevalence of topical retinoid use in women of reproductive age and to estimate risk of major congenital malformations (MCMs) associated with exposure of topical retinoids in early pregnancy.

                  

                  

                    Methods

                    Using publicly available nationwide data we estimated the annual prevalence of topical retinoid use in women of reproductive age (15–44 years) 2006–2024 in Denmark, Iceland, Norway and Sweden. We subsequently used linked individual-level data to perform a population-based cohort study using nationwide registers to estimate prevalence of use during pregnancy and risk of MCM. We included all infants with a gestational age of at least 22 weeks in Denmark, Iceland, Norway and Sweden from 1996 to 2020. We compared risks of nongenetic MCM among infants with first-trimester exposure to topical retinoids with: (i) unexposed infants and (ii) infants with first-trimester exposure to topical azelaic acid or topical clindamycin. We estimated adjusted risk ratios (aRRs) with log-binomial regression, adjusting for country of birth, maternal age, and birth year.

                  

                  

                    Results

                    The prevalence of topical retinoid use among women of reproductive age in Denmark, Iceland, Norway and Sweden increased from 8.7 per 1000 in 2006 to 28.5 per 1000 in 2024. Of 3 869 586 infants included in the cohort, 0.86 per 1000 were exposed to topical retinoids in the first trimester. Among infants exposed to topical retinoids, 3.3% had any MCM (71 of 2172), compared with 3.0% among unexposed (111 404 of 3 671 023) [aRR 1.1, 95% confidence interval (CI) 0.87–1.38] and 2.6% among infants exposed to azelaic acid or clindamycin (295 of 11 139) (aRR 1.1, 95% CI 0.87–1.47).

                  

                  

                    Conclusions

                    We observed a 3.3-fold increase in topical retinoid use over the past 18 years among women of reproductive age in the Nordic countries. We did not observe an increased risk of MCM associated with use of topical retinoids. Limiting to pregnancies resulting in a birth could underestimate both the prevalence of topical retinoid exposure and MCM risk.

                  },

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Santoro2025,

title = {Health outcomes and drug utilisation in children with Noonan syndrome: a European cohort study},

author = {Michele Santoro and Ingeborg Barisic and Alessio Coi and Joachim Tan and Ester Garne and Maria Loane and Ljubica Odak and Maria Valentina Abate and Elisa Ballardini and Clara Cavero-Carbonell and Miriam Gatt and Mika Gissler and Kari Klungsøyr and Nathalie Lelong and David Tucker and Diana Wellesley and Joan K. Morris},

doi = {10.1186/s13023-025-03594-7},

issn = {1750-1172},

year  = {2025},

date = {2025-12-00},

journal = {Orphanet J Rare Dis},

volume = {20},

number = {1},

publisher = {Springer Science and Business Media LLC},

abstract = {Abstract

          

            Background

            Noonan Syndrome (NS) is a rare multisystemic disorder with heterogeneous phenotypic manifestations. The aim of this study was to analyse rates of survival, hospitalisation, surgeries and prescriptions in children born with NS in the first 10 years of life.

          

          

            Methods

            This is a multi-centre population-based cohort study. Data on 175 liveborn children diagnosed with NS from 11 EUROCAT congenital anomaly registries were linked to healthcare databases. Each registry applied a common data model to standardise data and run common syntax scripts to produce aggregated results which were pooled using random effects meta-analyses.

          

          

            Results

            Mortality rates were high in the first year of life with 5.4% (95%CI 1.5%-10.1%) of children dying before the age of 1 year with a further 2% dying up to age 5. In the first year, 87.9% (95%CI 75.3%-94.3%) of children were hospitalized and the median Length Of hospital Stay (LOS) was 15.3 days (95%CI 9.3–21.2). After the first year, the proportion of children hospitalized remained higher than 70%, but the LOS decreased to 1.3 days per year. In the first 5 years, 65.2% of children underwent a median of two surgical procedures. The median age at first surgery was 29 weeks. The proportion of children with an antibiotic prescription increased from 53.6% at age 1 to 62.4% yearly until 4 years of age.

          

          

            Conclusions

            Children with NS have high mortality and morbidity not only in the first year of life but also up to five years of age. This study evaluated the health burden of NS and provided information for clinicians, health-care providers and families.

          },

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Rolová2025,

title = {Trends in opioid prescribing in Scandinavian countries from 2010 to 2023: Insights from multi‐metric evaluation},

author = {Gabriela Rolová and Svetlana Skurtveit and Marte Handal and Geana Paula Kurita and Torgeir Gilje Lid and Ingvild Odsbu and Mikael Hoffmann},

doi = {10.1002/bcp.70177},

issn = {1365-2125},

year  = {2025},

date = {2025-12-00},

journal = {Br J Clin Pharmacol},

volume = {91},

number = {12},

pages = {3341--3352},

publisher = {Wiley},

abstract = {

                    Aims

                    Monitoring opioid prescribing across different healthcare systems is essential to understanding population‐level exposure and informing global health policies. This study examined opioid utilization in Scandinavian countries between 2010 and 2023 using multiple complementary metrics, addressing the limitations of single‐metric comparisons.

                  

                  

                    Methods

                    A repeated cross‐sectional study utilizing publicly available drug use statistics on opioid analgesics (ATC group N02A) dispensed in pharmacies from Denmark, Norway and Sweden. We assessed annual changes in utilization based on four metrics: 1‐year prevalence (users/1000 inhabitants/year), defined daily doses (DDD)/1000 inhabitants/day (TID), morphine milligram equivalents (MMEs)/TID, and MMEs/user/year.

                  

                  

                    Results

                    Opioid use declined in Denmark and Sweden—in both 1‐year user prevalence and volumes of MMEs—while stabilizing in Norway. Norway consistently had a higher and stable prevalence of opioid users. Denmark led in total amounts of MMEs dispensed, likely due to more frequent morphine and oxycodone use, whereas Norway ranked highest in DDDs. Denmark and Sweden showed increasing preference for “strong opioids”, while codeine‐paracetamol and tramadol remained predominant in Norway. The prevalence of oxycodone users increased in Norway and Sweden, with Sweden having the highest prevalence of users but the lowest annual average volumes per user.

                  

                  

                    Conclusions

                    This study found major differences in total opioid use and substance‐specific prescribing patterns, reflecting diverse pain management strategies across Scandinavia. Changing use patterns suggest evolving prescribing strategies and possible shifts in the target group for opioid pain therapy. In addition, metric‐dependent variation underscores the need for using multiple complementary metrics to accurately interpret opioid utilization trends.

                  },

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Srinivas2025,

title = {Attention-deficit hyperactivity disorder medication use in pregnancy and risk of miscarriage},

author = {Chaitra Srinivas and Øystein Karlstad and Hein Stigum and Kari Furu and Carolyn E. Cesta and Johan Reutfors and Vidar Hjellvik and Jennifer A. Hutcheon and Jacqueline M. Cohen},

doi = {10.1192/bjp.2025.10467},

issn = {1472-1465},

year  = {2025},

date = {2025-11-07},

journal = {Br J Psychiatry},

pages = {1--7},

publisher = {Royal College of Psychiatrists},

abstract = {

                    Background

                    An increasing number of women of childbearing age are treated for attention-deficit hyperactivity disorder (ADHD). Limited evidence exists on risk of pregnancy loss associated with ADHD medication use in early pregnancy.

                  

                  

                    Aims

                    To assess whether ADHD medication use during pregnancy is associated with increased risk of miscarriage.

                  

                  

                    Method

                    

                      We conducted a nationwide, register-based, case–control study, using linked Norwegian data from Medical Birth Registry of Norway, Norwegian Patient Registry, Norwegian Control and Payment of Health Reimbursements Database and Norwegian Prescription Database. Among pregnant women with ADHD, those with miscarriage (

                      n

                      = 2993 cases) were matched with up to four live births (

                      n

                      = 10 305 controls) by maternal age and year of conception. ADHD medication exposure during pregnancy was defined as any use (one or more filled prescriptions) and categorised into tertiles of total defined daily doses (DDDs) as a proxy for dose. The main outcome was miscarriage (pregnancy loss before 20 weeks). Conditional logistic regression was used to estimate adjusted odds ratios (aORs) with 95% confidence intervals, adjusting for psychiatric comorbidities, psychotropic and teratogenic medications, and maternal age at conception.

                    

                  

                  

                    Results

                    Of 13 298 pregnancies, 1389 (10.5%) were exposed to ADHD medications. Any ADHD medication use was associated with increased miscarriage risk (aOR 1.60, 95% CI 1.41–1.83). Methylphenidate (aOR 1.55, 95% CI 1.35–1.79), lisdexamfetamine (aOR 1.81, 95% CI 1.06–3.10) and atomoxetine (aOR 2.34, 95% CI 1.41–3.89) were associated with increased risks. Higher levels of medication exposure, categorised by DDD tertiles, were associated with increased odds of miscarriage, increasing from 1.14 (95% CI 0.91–1.42) for the lowest tertile to 2.11 (95% CI 1.71–2.60) for the highest.

                  

                  

                    Conclusions

                    ADHD medication use during pregnancy is associated with increased miscarriage risk. However, filled prescriptions may not reflect actual use. Further research is needed to clarify these associations and refine risk estimates.

                  },

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Beau2025,

title = {Identifying Maternal Conditions Leading to Gabapentinoid Prescriptions in Pregnancy Using Electronic Health Records from Six European Countries: A Contribution from the IMI ConcePTION Project},

author = {Anna-Belle Beau and Olga Paoletti and Justine Bénévent and Marie Beslay and Xavier Moisset and Elisa Ballardini and Laia Barrachina-Bonet and Clara Cavero-Carbonell and Alex Coldea and Laura García-Villodre and Anja Geldhof and Rosa Gini and Mika Gissler and Sue Jordan and Maarit K. Leinonen and Marco Manfrini and Visa Martikainen and Vera R. Mitter and Joan K. Morris and Amanda J. Neville and Hedvig Nordeng and Aurora Puccini and Jingping Mo and Christine Damase-Michel},

doi = {10.1007/s40264-025-01565-2},

issn = {1179-1942},

year  = {2025},

date = {2025-11-00},

journal = {Drug Saf},

volume = {48},

number = {11},

pages = {1189--1204},

publisher = {Springer Science and Business Media LLC},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Chan2025,

title = {International Trends in Opioid Prescribing by Age and Sex from 2001 to 2019: An Observational Study Using Population-Based Databases from 18 Countries and One Special Administrative Region},

author = {Adrienne Y. L. Chan and Shahram Bahmanyar and Kebede Beyene and Greta Bushnell and Bruce Carleton and Amy Hai Yan Chan and Sharon Cook and Stephen Crystal and Kari Furu and Svetla Gadzhanova and Patricia García Poza and Rosa Gini and Sabrina Giometto and Jeff Harrison and Ulrike Haug and Christine Hsu and Harpa Lind Hjördísar Jónsdóttir and Joe Kai and Øystein Karlstad and Ju Hwan Kim and Kiyoshi Kubota and Edward Chia-Cheng Lai and Hyesung Lee and Wallis C. Y. Lau and Kathy H. Li and Ersilia Lucenteforte and Géric Maura and Anke Neumann and Virginia Pate and Anton Pottegård and Nadeem Qureshi and Lotte Rasmussen and Johan Reutfors and Elizabeth E. Roughead and Leena Saastamoinen and Tsugumichi Sato and Oliver Scholle and C. C. M. Schuiling-Veninga and Chin-Yao Shen and Ju-Young Shin and Til Stürmer and Katja Taxis and Marco Tuccori and Stephen Weng and Kirstie H. T. W. Wong and Helga Zoega and Kenneth K. C. Man and Ian C. K. Wong},

doi = {10.1007/s40263-025-01215-2},

issn = {1179-1934},

year  = {2025},

date = {2025-11-00},

journal = {CNS Drugs},

volume = {39},

number = {11},

pages = {1173--1185},

publisher = {Springer Science and Business Media LLC},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Ompad2025,

title = {Current Use of Common Data Models in the Nordic Countries},

author = {Gerard Ompad and Carolyn E. Cesta and Jacqueline M. Cohen and Maarit K. Leinonen and Heidi Taipale and Huiqi Li and Lárus S. Guðmundsson and Mika Gissler and Maurizio Sessa},

doi = {10.1002/pds.70242},

issn = {1099-1557},

year  = {2025},

date = {2025-11-00},

journal = {Pharmacoepidemiology and Drug},

volume = {34},

number = {11},

publisher = {Wiley},

abstract = {ABSTRACT

                  

                    Purpose

                    Common data models (CDMs) standardize healthcare data to facilitate reproducible and consistent analyses, supporting decision‐making in medicine and vaccine safety and pharmacoepidemiology. Despite their global recognition, the implementation and use of CDMs in the Nordic countries remain underexplored, particularly in the context of cross‐national collaborations.

                  

                  

                    Objectives

                    We aimed to assess the adoption, application, benefits, and limitations of CDMs currently used in the Nordic countries.

                  

                  

                    Methods

                    A survey was distributed to member research groups in the Nordic PharmacoEpidemiological Network (NorPEN) across Denmark, Finland, Iceland, Norway, and Sweden. Respondents provided information on CDM usage, collaborations, and perceptions of CDM advantages and limitations. Descriptive analyses were performed on aggregated data, maintaining respondent confidentiality.

                  

                  

                    Results

                    Twenty‐two of 25 research groups responded (88% response rate), and 13 (59%) reported using one or more CDMs. Research groups in all Nordic countries reported using CDMs. OMOP was the most utilized CDM, primarily in academic settings. Nordic‐ and project‐specific CDMs proved effective for targeted research, particularly in data standardization. Many CDMs lacked adaptability for pregnancy‐specific data, while there was widespread use of CDMs developed specifically for linked mother–child data (e.g., NorPreSS, ConcePTION). Collaborative networks revealed the use of CDMs by research groups in the Nordics to support global partnerships.

                  

                  

                    Conclusions

                    The study highlights significant variability in CDM adoption across Nordic countries. While OMOP supports global collaboration, regional models like the Nordic CDM and NorPreSS align with local needs. Future efforts should address limitations in adaptability and interoperability to enhance the integration and utility of CDMs for Nordic and international research.

                  },

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Jensen2025,

title = {EpiCore

                    —A Common Data Model for Pharmacoepidemiological Studies in Denmark, Norway, and Sweden},

author = {Peter Bjødstrup Jensen and Jacob H. Andersen and Martin Thomsen Ernst and Morten Olesen and Øystein Karlstad and Kari Furu and Julia Eriksson and Karin Gembert and Anton Pottegård},

doi = {10.1002/pds.70241},

issn = {1099-1557},

year  = {2025},

date = {2025-11-00},

journal = {Pharmacoepidemiology and Drug},

volume = {34},

number = {11},

publisher = {Wiley},

abstract = {ABSTRACT

                  

                    Purpose

                    The use of common data models (CDMs) is increasing; however, the complexity of many CDM frameworks constitutes a barrier for their use. For many local and collaborative use cases, simpler CDMs can suffice. Here, we propose the EpiCore CDM, a simple CDM framework for use in Scandinavian pharmacoepidemiological studies.

                  

                  

                    Methods

                    The EpiCore CDM was developed based on a set of guiding principles. It should (i) accommodate the most common elements of typical data sources in the field and region, (ii) be accessible to users without needing advanced technical expertise or database infrastructure, (iii) prioritize structural and syntactic harmonization of data and defer clinical concept mapping to the analytical phase, (iv) be usable in both collaborative and single site settings, and (v) include support for quality control procedures.

                  

                  

                    Results

                    The EpiCore CDM comprises two mandatory administrative tables (person and observation), six optional event tables (diagnosis, procedure, encounter, drug, primcare, and cancer) and three optional lookup tables (drug_info, organisation_info, and prescriber_info). Each table, along with its columns and constraints is specified according to an EpiCore CDM specification template. This provides easy documentation and integrates with an R‐package called EpiCoreAssistant, which provides quality control tools for testing the compliance of a CDM instance with the EpiCore specification. In the event that a project requires customization of the CDM, this is easily implemented in the template and testing. A step‐by‐step description is presented, demonstrating the steps involved in a typical CDM‐based collaborative pharmacoepidemiological study using the EpiCore CDM.

                  

                  

                    Conclusions

                    We present the EpiCore CDM, a specification template and an R package that offers a simple framework for improved workflows, standardizations and collaboration, focused on Scandinavian pharmacoepidemiological studies and with relevance for a broad palette of register‐based health care researchers.

                  },

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Hemmingsen2025b,

title = {Maternal hormonal contraceptive use and childhood central nervous system tumor risk in a large Scandinavian cohort},

author = {Caroline H. Hemmingsen and Susanne K. Kjaer and Sarah Hjorth and Ulrika Nörby and Anton Pottegård and René Mathiasen and Charlotte Wessel Skovlund and Maarit K. Leinonen and Hedvig Nordeng and Lina S. Mørch and Marie Hargreave},

doi = {10.1002/ijc.35509},

issn = {1097-0215},

year  = {2025},

date = {2025-10-15},

journal = {Intl Journal of Cancer},

volume = {157},

number = {8},

pages = {1557--1565},

publisher = {Wiley},

abstract = {AbstractAn association between maternal hormonal contraception use and childhood central nervous system (CNS) tumors has been suggested, but findings are inconclusive. This population‐based cohort study includes Scandinavian nationwide registry data on liveborn children (1996–2018). Children were followed from birth until CNS tumor (<20 years) or censoring (other cancer, emigration, death, 20th birthday, or end of follow‐up in 2017–2020). Cox proportional hazards models estimated hazard ratios (HRs) and 95% confidence intervals (95% CIs) for the association between maternal hormonal contraception use (any type, type‐specific) and CNS tumor risk (any, any malignant, type‐specific). Maternal use was categorized as “recent use” (0–3 months before or during pregnancy, except for non‐oral progestin‐only types), “previous use” (before recent use), and “no use”. A total of 3,183,316 children were followed for 29,455,528 person‐years, during which time 1384 children developed a CNS tumor (610 malignant). Compared with no use, maternal previous or recent use of any hormonal contraception (HR 0.93, 95% CI 0.82–1.05; HR 0.99, 95% CI 0.83–1.19), combined and progestin‐only types (oral, non‐oral), were not associated with childhood CNS tumor risk. However, maternal recent progestin‐only injection use was associated with malignant childhood CNS tumors (HR 3.95, 95CI % 1.46–10.68), compared with no use (number needed to harm: 1 per 14,577 person‐years). In conclusion, no association was found between maternal use of common types of hormonal contraception and CNS tumors in children. The rarely used progestin‐only injections (medroxyprogesterone acetate) were associated with malignant CNS tumor risk in children, though based on few children.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{BangMadsen2025,

title = {In utero exposure to methylphenidate, amphetamines and atomoxetine and offspring neurodevelopmental disorders – a population-based cohort study and meta-analysis},

author = {Kathrine Bang Madsen and Henrik Larsson and Charlotte Skoglund and Xiaoqin Liu and Trine Munk-Olsen and Veerle Bergink and Jeffrey H. Newcorn and Samuele Cortese and Paul Lichtenstein and Ralf Kuja-Halkola and Zheng Chang and Brian D’Onofrio and Per Hove Thomsen and Kari Klungsøyr and Isabell Brikell and Miguel Garcia-Argibay},

doi = {10.1038/s41380-025-02968-4},

issn = {1476-5578},

year  = {2025},

date = {2025-09-00},

journal = {Mol Psychiatry},

volume = {30},

number = {9},

pages = {3885--3894},

publisher = {Springer Science and Business Media LLC},

abstract = {Abstract

          The use of Attention-Deficit/Hyperactivity Disorder (ADHD) medications during pregnancy is increasing, raising concerns about potential long-term effects on offspring. This study investigates in utero exposure to methylphenidate, amphetamines and atomoxetine and risk of offspring neurodevelopmental disorders (NDDs). The population-based cohort study identified from Swedish registers included 861,650 children born by 572,731 mothers from 2008–2017. We categorized exposure based on redeemed medication during pregnancy and compared exposed children to those whose mothers discontinued medication before conception. Main outcomes were any NDD, including ADHD and autism spectrum disorder (ASD). Cox proportional hazards regression estimated hazard ratios (HRs), adjusting for maternal psychiatric and sociodemographic factors. Sensitivity analyses included stratifications by medication type, timing, and duration of exposure, and sibling comparisons. We also performed a meta-analysis combining data from the present study with those from a previous Danish study. Results showed no increased risk for any NDD (HRadjusted 0.95, 95% CI 0.82–1.11), ADHD (HRadjusted 0.92, 95% CI 0.78–1.08), or ASD (HRadjusted 0.86, 95% CI 0.63–1.18). Sensitivity analyses showed consistent patterns of no increased risks across different exposure durations, medication types and between siblings. Meta-analyses further supported the findings (pooled HR for any NDD 1.00, 95% CI 0.83;1.20). Our study provides evidence that in utero exposure to ADHD medications does not increase the risk of long-term NDDs in offspring. This study replicates safety data for methylphenidate and extends it with new safety data on amphetamines and atomoxetine. These findings are crucial for informing clinical guidelines and helping healthcare providers and expectant mothers make informed decisions.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Tran2025,

title = {Risk of Major Congenital Malformations Following Prenatal Exposure to Smoking Cessation Medicines},

author = {Duong T. Tran and Jacqueline M. Cohen and Sarah Donald and Carolyn E. Cesta and Kari Furu and Lianne Parkin and Sallie-Anne Pearson and Johan Reutfors and Annelies L. Robijn and Helga Zoega and Nicholas Zwar and Alys Havard},

doi = {10.1001/jamainternmed.2025.0290},

issn = {2168-6106},

year  = {2025},

date = {2025-06-01},

journal = {JAMA Intern Med},

volume = {185},

number = {6},

publisher = {American Medical Association (AMA)},

abstract = {ImportanceNicotine replacement therapy (NRT), varenicline, and bupropion are effective smoking cessation pharmacotherapies, but evidence on fetal safety is limited.ObjectiveTo assess whether prenatal use of smoking cessation pharmacotherapies was associated with increased risks of major congenital malformations (MCMs).Design, Setting, and ParticipantsThis retrospective cohort study was conducted across 4 countries, and results were pooled via meta-analyses. Records of all births (2001-2020) in New South Wales (NSW; Australia), New Zealand (NZ), Norway, and Sweden were linked to prescribed medicine dispensings, hospital admission, outpatient, and death data. Follow-up ended December 31, 2021, and the data were analyzed between August and October 2023. The base cohort comprised 391 474 infants among 267 522 women who smoked during the first trimester or were dispensed a smoking cessation pharmacotherapy 90 days before conception or during the first trimester.ExposuresSupply of NRT, varenicline, and bupropion overlapping the first trimester. Unexposed infants were born to women who smoked but were not dispensed a pharmacotherapy 90 days preconception and the first trimester. Propensity score matching (1:10) was used.Main Outcomes and MeasuresMCM overall and subgroups.ResultsThe mean (SD) maternal age at childbirth was 27.2 (6.0) years. Analyses included 9325 infants exposed to NRT (NSW, NZ), 3031 to varenicline (NSW, NZ, Norway, and Sweden), and 1042 to bupropion (NSW, NZ). Compared with unexposed infants, there were no differences in prevalence of MCMs overall following NRT exposure (37.6 vs 34.4 per 1000 live births; adjusted relative risk [aRR], 1.10; 95% CI, 0.98-1.22), varenicline (32.7 vs 36.6; aRR, 0.90; 95% CI, 0.73-1.10), or bupropion (35.5 vs 38.8; aRR, 0.93; 95% CI, 0.67-1.29). NRT analyses showed no difference in the risk of MCMs of the heart, limbs, genital organs, kidney/urinary tract, respiratory system, and orofacial clefts but a higher risk of digestive organ MCMs (3.8 vs 2.5 per 1000 live births; aRR, 1.53; 95% CI, 1.05-2.23; P = .41 after multiple comparison adjustment). Varenicline analyses revealed no difference in the risk of heart, limb, and genital MCMs but a higher risk of kidney/urinary tract MCMs (11.5 vs 4.2 per 1000 live births; aRR, 2.75; 95% CI, 1.42-5.34; P = .09 after multiple comparison adjustment), with findings for other MCMs being too imprecise. For bupropion, data were too sparse to estimate the risk of MCM subgroups.Conclusions and RelevanceThe results of this cohort study suggest that there is no clear increased risk of MCMs associated with prenatal use of NRT and varenicline compared with smoking during the first trimester.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Baxter2025b,

title = {Use of psychotropic medications among glioma patients in Denmark, Norway, Sweden, and Wales},

author = {Sarah M. Baxter and Tone Bjørge and Rolf Bjerkvig and Christopher Cardwell and Anders Engeland and Julia Eriksson and Laurel Habel and Jannicke Igland and Kari Klungsøyr and Astrid Lunde and Hrvoje Miletic and Morten Olesen and Anton Pottegård and Johan Reutfors and Mohammad Jalil Sharifian and Marie Linder and Blánaid Hicks},

doi = {10.1007/s11060-025-04996-0},

issn = {1573-7373},

year  = {2025},

date = {2025-06-00},

journal = {J Neurooncol},

volume = {173},

number = {2},

pages = {383--395},

publisher = {Springer Science and Business Media LLC},

abstract = {Abstract

          

            Purpose

            Glioma patients often suffer from psychiatric and neurological conditions. However, little is known about the patterns of use of psychotropic drugs pre- and post-glioma diagnosis. Therefore, we assessed temporal patterns of psychotropic prescriptions among glioma patients, compared to an age and sex matched comparison cohort in four European countries.

          

          

            Methods

            Incident gliomas were identified in Wales from the Secured Anonymized Information Linkage Databank (2005–2016) and population-based registries in Denmark (2001–2016), Norway (2006–2019), and Sweden (2008–2018). From each data source, a cancer-free comparison cohort was matched to the glioma cases by age and sex. We calculated rates of new psychotropic prescriptions and any psychotropic prescriptions during the 2 years prior to and post glioma diagnosis. Analyses were stratified by histological subtypes and subclasses of psychotropic medications.

          

          

            Results

            We identified 16,007 glioma patients. The rate of new psychotropic drug use increased from 7 months before diagnosis, peaking around the month of glioma diagnosis (with peak rates ranging from 227 to 753 new psychotropic drugs per 1000 person-months). New use remained substantially higher among glioma patients than comparators throughout the 2-year follow-up period after glioma diagnosis, though rates of new use continued to decline throughout. New use was largely driven by antiepileptics, anxiolytics, hypnotics, and sedatives. Patterns were similar when analyses were stratified by histological subtype.

          

          

            Conclusion

            Psychotropic drug use among glioma patients was high, and elevations observed around the time of cancer diagnosis, largely driven by antiepileptics, anxiolytics, hypnotics, and sedatives, are likely associated with the consequences of the disease.

          },

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Ruiz2025,

title = {Trends in the use of drugs with weight‐loss effect: Scandinavian study from 2017 to 2023},

author = {Paz Lopez‐Doriga Ruiz and Lars Bakke Hindenes and Øystein Karlstad and Kjersti Nøkleby and Haakon E. Meyer and Aurélie Mailhac and Rickard Ljung and Reimar W. Thomsen and Kari Furu},

doi = {10.1111/dom.16291},

issn = {1463-1326},

year  = {2025},

date = {2025-05-00},

journal = {Diabetes Obesity Metabolism},

volume = {27},

number = {5},

pages = {2901--2905},

publisher = {Wiley},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Johnson2025,

title = {Use of signal detection methods to identify associations between prenatal medication exposure and subsequent childhood cancers: a Nordic hypothesis-generating registry-based study},

author = {Hannah Johnson and Sarah Hjorth and Joan Morris and Anton Pottegård and Maarit Leinonen and Ulrika Norby and Hedvig Nordeng},

doi = {10.1080/14740338.2025.2461204},

issn = {1744-764X},

year  = {2025},

date = {2025-02-12},

journal = {Expert Opinion on Drug Safety},

pages = {1--12},

publisher = {Informa UK Limited},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Baxter2025c,

title = {Glucagon-Like Peptide 1 Receptor Agonists and Risk of Thyroid Cancer: An International Multisite Cohort Study},

author = {Sarah M. Baxter and Lars Christian Lund and Jacob H. Andersen and Thomas H. Brix and Laszlo Hegedüs and Miyuki Hsing-Chun Hsieh and Chris Tzu-Ting Su and Michael Chun-Yuan Cheng and Zoe Chi-Jui Chang and Edward Chia-Cheng Lai and Swaleh Hussain and Cherry Chu and Tara Gomes and Tony Antoniou and Antoine Eskander and Zachary Bouck and Mina Tadrous and Sungho Bea and Eun-Young Choi and Ju-Young Shin and Karin Modig and Mats Talbäck and Rickard Ljung and Hanne Løvdal Gulseth and Øystein Karlstad and Blánaid Hicks and Anton Pottegård},

doi = {10.1089/thy.2024.0387},

issn = {1557-9077},

year  = {2025},

date = {2025-01-01},

journal = {Thyroid®},

volume = {35},

number = {1},

pages = {69--78},

publisher = {SAGE Publications},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Baxter2025,

title = {Glucagon-Like Peptide 1 Receptor Agonists and Risk of Thyroid Cancer: An International Multisite Cohort Study},

author = {Sarah M. Baxter and Lars Christian Lund and Jacob H. Andersen and Thomas H. Brix and Laszlo Hegedüs and Miyuki Hsing-Chun Hsieh and Chris Tzu-Ting Su and Michael Chun-Yuan Cheng and Zoe Chi-Jui Chang and Edward Chia-Cheng Lai and Swaleh Hussain and Cherry Chu and Tara Gomes and Tony Antoniou and Antoine Eskander and Zachary Bouck and Mina Tadrous and Sungho Bea and Eun-Young Choi and Ju-Young Shin and Karin Modig and Mats Talbäck and Rickard Ljung and Hanne Løvdal Gulseth and Øystein Karlstad and Blánaid Hicks and Anton Pottegård},

doi = {10.1089/thy.2024.0387},

issn = {1557-9077},

year  = {2025},

date = {2025-01-01},

journal = {Thyroid®},

volume = {35},

number = {1},

pages = {69--78},

publisher = {Mary Ann Liebert Inc},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Rasmussen2024c,

title = {Treatment patterns of antidepressants in children and adolescents in Scandinavia},

author = {Lotte Rasmussen and Peter Bjødstrup Jensen and Johan Reutfors and Kari Furu and Svetlana Skurtveit and Randi Selmer and Per Damkier and Mette Bliddal and Rikke Wesselhoeft},

doi = {10.1007/s00787-024-02433-7},

issn = {1435-165X},

year  = {2025},

date = {2025-01-00},

journal = {Eur Child Adolesc Psychiatry},

volume = {34},

number = {1},

pages = {159--167},

publisher = {Springer Science and Business Media LLC},

abstract = {Abstract

          The aim of this study was to examine variations in use of antidepressants among children and adolescents in the three Scandinavian countries (Sweden, Norway, and Denmark). We identified new users of antidepressants (5–17 years) during 2007–2018 and described the annual incidence rate, treatment duration, concomitant psychotropic drug use, and the clinical setting of the prescribing physician (in Sweden and Denmark). Incident use of antidepressants increased by a factor 1.9 in Sweden, 1.3 in Norway and decreased by a factor 0.6 in Denmark during the study period. In Sweden, 58% of antidepressant users were covered by a prescription 12 months after initiation compared to 40% in Norway and 49% in Denmark. Also, 34% of Swedish antidepressant users were in continuous treatment after 12 months compared to 26% in Norway and 31% in Denmark. Concomitant use of other psychotropics was more common in Sweden (57%) than in Norway (37%) and Denmark (27%). During 2007–2018, clinicians from psychiatry settings initiated 75% of antidepressant treatments in Sweden, while this was the case for 50% of prescriptions in Denmark, although the proportion increased over time. The number of new antidepressant users is high and still rising in Sweden compared to Norway and Denmark. Swedish antidepressant users are more likely to use other psychotropics and to be covered by an antidepressant prescription after one year. Most antidepressants in Sweden are prescribed by physicians within psychiatric settings suggesting that they are based on specialized psychiatric evaluation.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Hemmingsen2025c,

title = {Maternal use of hormonal contraception and risk of childhood leukemia: A Scandinavian population-based cohort study},

author = {Caroline H. Hemmingsen and Susanne K. Kjaer and Sarah Hjorth and Ulrika Nörby and Anne Broe and Anton Pottegård and Justine Bénévent and Kjeld Schmiegelow and Charlotte Wessel Skovlund and Maarit K. Leinonen and Hedvig Nordeng and Lina S. Mørch and Marie Hargreave},

doi = {10.1016/j.ejca.2024.115168},

issn = {0959-8049},

year  = {2025},

date = {2025-01-00},

journal = {European Journal of Cancer},

volume = {215},

publisher = {Elsevier BV},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Vegrim2024,

title = {High‐dose folic acid use and cancer risk in women who have given birth: A register‐based cohort study},

author = {Håkon Magne Vegrim and Julie Werenberg Dreier and Jannicke Igland and Silje Alvestad and Nils Erik Gilhus and Mika Gissler and Maarit K. Leinonen and Torbjörn Tomson and Helga Zoega and Jakob Christensen and Marte‐Helene Bjørk},

doi = {10.1111/epi.18146},

issn = {1528-1167},

year  = {2025},

date = {2025-01-00},

journal = {Epilepsia},

volume = {66},

number = {1},

pages = {75--88},

publisher = {Wiley},

abstract = {AbstractObjectiveThis study was undertaken to study whether high‐dose folic acid (>1 mg daily) use is associated with an increased risk of cancer in all women who have given birth and in women with epilepsy. High‐dose folic acid supplementation during pregnancy has been linked to increased cancer risk in children born to mothers with epilepsy.MethodsWe identified women with their first pregnancy in Denmark (1997–2017), Norway (2005–2017), and Sweden (2006–2017) using medical birth registers, linking individual data across nationwide health registers and statistical agencies. Exposure was defined as filled prescriptions for high‐dose folic acid, considered time‐varyingly. The primary outcome was the first malignant cancer diagnosis. Hazard ratios (HRs) of cancer after high‐dose folic acid exposure were estimated using Cox proportional hazard models with 95% confidence intervals (CIs), adjusted for confounders including antiseizure medication (ASM) use, and stratified by maternal epilepsy diagnosis. A 6‐month time lag was applied, as cancer is unlikely to develop immediately.ResultsWith up to 21 years of follow‐up, we identified 1 465 785 women who gave birth, including 64 485 (4.4%) exposed to high‐dose folic acid. In the exposed group, 755 cancer cases were observed (208 per 100 000 person‐years, 95% CI = 193.8–223.5), compared with 18 702 cases in the unexposed group (164 per 100 000 person‐years, 95% CI = 161.5–166.2), yielding a 20% increased cancer risk overall (adjusted HR = 1.2, 95% CI = 1.1–1.2). This risk was attenuated after the 6‐month lag analysis (adjusted HR = 1.1, 95% CI = 1.04–1.2). The risk for non‐Hodgkin lymphoma was increased in all analyses (n = 28, adjusted HR = 2.0, 95% CI = 1.3–2.9). The association between high‐dose folic acid use and overall cancer risk was similar in those with epilepsy regardless of ASM use (adjusted HR = 1.3, 95% CI = 1.0–1.8).SignificanceHigh‐dose folic acid use was associated with increased overall cancer risk in women who have given birth, with a consistent association with non‐Hodgkin lymphoma, including those with epilepsy, regardless of ASM use.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Rasmussen2024b,

title = {Treatment patterns of antidepressants in children and adolescents in Scandinavia},

author = {Lotte Rasmussen and Peter Bjødstrup Jensen and Johan Reutfors and Kari Furu and Svetlana Skurtveit and Randi Selmer and Per Damkier and Mette Bliddal and Rikke Wesselhoeft},

doi = {10.1007/s00787-024-02433-7},

issn = {1435-165X},

year  = {2025},

date = {2025-01-00},

journal = {Eur Child Adolesc Psychiatry},

volume = {34},

number = {1},

pages = {159--167},

publisher = {Springer Science and Business Media LLC},

abstract = {Abstract

          The aim of this study was to examine variations in use of antidepressants among children and adolescents in the three Scandinavian countries (Sweden, Norway, and Denmark). We identified new users of antidepressants (5–17 years) during 2007–2018 and described the annual incidence rate, treatment duration, concomitant psychotropic drug use, and the clinical setting of the prescribing physician (in Sweden and Denmark). Incident use of antidepressants increased by a factor 1.9 in Sweden, 1.3 in Norway and decreased by a factor 0.6 in Denmark during the study period. In Sweden, 58% of antidepressant users were covered by a prescription 12 months after initiation compared to 40% in Norway and 49% in Denmark. Also, 34% of Swedish antidepressant users were in continuous treatment after 12 months compared to 26% in Norway and 31% in Denmark. Concomitant use of other psychotropics was more common in Sweden (57%) than in Norway (37%) and Denmark (27%). During 2007–2018, clinicians from psychiatry settings initiated 75% of antidepressant treatments in Sweden, while this was the case for 50% of prescriptions in Denmark, although the proportion increased over time. The number of new antidepressant users is high and still rising in Sweden compared to Norway and Denmark. Swedish antidepressant users are more likely to use other psychotropics and to be covered by an antidepressant prescription after one year. Most antidepressants in Sweden are prescribed by physicians within psychiatric settings suggesting that they are based on specialized psychiatric evaluation.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Hemmingsen2025,

title = {Maternal use of hormonal contraception and risk of childhood leukemia: A Scandinavian population-based cohort study},

author = {Caroline H. Hemmingsen and Susanne K. Kjaer and Sarah Hjorth and Ulrika Nörby and Anne Broe and Anton Pottegård and Justine Bénévent and Kjeld Schmiegelow and Charlotte Wessel Skovlund and Maarit K. Leinonen and Hedvig Nordeng and Lina S. Mørch and Marie Hargreave},

doi = {10.1016/j.ejca.2024.115168},

issn = {0959-8049},

year  = {2025},

date = {2025-01-00},

journal = {European Journal of Cancer},

volume = {215},

publisher = {Elsevier BV},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Cesta2025,

title = {In Memoriam—Helle Kieler (1956–2024)},

author = {Carolyn E. Cesta and Gabriella Bröms and Kari Furu and Sonia Hernandez‐Diaz and Krista F. Huybrechts and Olof Stephansson and Helga Zoega},

doi = {10.1002/pds.70073},

issn = {1099-1557},

year  = {2025},

date = {2025-01-00},

journal = {Pharmacoepidemiology and Drug},

volume = {34},

number = {1},

publisher = {Wiley},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Brett2025,

title = {Global Trends in Analgesic Opioid Use in Pregnancy: A Retrospective Cohort Study},

author = {Jonathan Brett and Carolyn E. Cesta and Malcolm B. Gillies and Brian T. Bateman and Adrienne Y. L. Chan and Michael C.-Y. Cheng and Yongtai Cho and Eunyoung Choi and Jacqueline M. Cohen and Sarah Donald and Kari Furu and Mika Gissler and Tara Gomes and Alice Havard and Sonya Hernandez-Diaz and Miyuki H. C. Hsieh and Krista F. Huybrechts and Par Karlsson and Erin Kelty and Edward C. C. Lai and Shaleesa Ledlie and Tianru Wang and Maarit K. Leinonen and Lianne Parkin and Johan Reutfors and Jo-Young Shin and Chris T. T. Su and Bianca Varney and Ian C. K. Wong and Kenneth K. C. Man and Helga Zoega},

doi = {10.1097/aln.0000000000005418},

issn = {1528-1175},

year  = {2025},

date = {2025-00-00},

volume = {142},

number = {6},

pages = {1100--1113},

publisher = {Ovid Technologies (Wolters Kluwer Health)},

abstract = {

            Background:

            Pain is common during pregnancy, yet there are few contemporary studies of opioid use in pregnancy. This study aimed to describe prescription analgesic opioid use during pregnancy across four regions: Oceania (New South Wales, Australia, and New Zealand), North America (Ontario, Canada, and United States), Northern Europe (Denmark, Finland, Iceland, Norway, Sweden, and United Kingdom), and East Asia (Hong Kong, South Korea, and Taiwan).

          

          

            Methods:

            A common protocol was applied to population-based data to measure analgesic opioid dispensing or prescriptions during pregnancy before birth in 2000 to 2020. The populations captured included those with public and private insurance in the United States, a sample of primary care practices in the United Kingdom, and whole-of-population cohorts in the remainder of the locations. This study examined prevalence of use, defined as at least one dispensing or prescribing and estimated trends over time. Use by sociodemographic and pregnancy characteristics is described.

          

          

            Results:

            Among a total of 20,306,228 pregnancies, 1,115,853 (55 per 1,000) had at least one analgesic opioid dispensing or prescription, ranging from 4 per 1,000 in the United Kingdom to 191 per 1,000 in the U.S. publicly insured population. The greatest relative decrease in prevalence was observed in Hong Kong (prevalence ratio, 0.2; 95% CI, 0.1 to 0.2 between 2005 and 2020), and the greatest increase was in Iceland (prevalence ratio, 4.4; 95% CI, 3.7 to 5.2 between 2004 and 2017). Codeine and tramadol were among the three most prevalent opioids in most populations. In a sensitivity analysis defining opioid use as two or more opioid -dispensing or -prescribing events, the prevalence of opioid use across populations was 17 per 1,000.

          

          

            Conclusions:

            In this large multinational study, wide global variation in the prevalence of analgesic opioid use in pregnancy was observed, yet patterns of use by sociodemographic and pregnancy characteristics were relatively consistent. Analgesic opioid use remained stable or downward trending over time in most, but not all, countries.

          },

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Wittström2024,

title = {Lithium Use During Pregnancy in 14 Countries},

author = {Felix Wittström and Carolyn E. Cesta and Brian T. Bateman and Marie Bendix and Mette Bliddal and Adrienne Y. L. Chan and Yongtai Cho and Eun-Young Choi and Jacqueline M. Cohen and Sarah Donald and Mika Gissler and Alys Havard and Sonia Hernandez-Diaz and Krista F. Huybrechts and Bianca Kollhorst and Edward Chia-Cheng Lai and Maarit K. Leinonen and Brian M. H. Li and Kenneth K. C. Man and Vanessa W. S. Ng and Lianne Parkin and Laura Pazzagli and Lotte Rasmussen and Ran S. Rotem and Tania Schink and Ju-Young Shin and Duong T. Tran and Ian C. K. Wong and Helga Zoega and Johan Reutfors},

doi = {10.1001/jamanetworkopen.2024.51117},

issn = {2574-3805},

year  = {2024},

date = {2024-12-02},

journal = {JAMA Netw Open},

volume = {7},

number = {12},

publisher = {American Medical Association (AMA)},

abstract = {ImportanceIn pregnancy, the benefits of lithium treatment for relapse prevention in psychiatric conditions must be weighed against potential teratogenic effects. Currently, there is a paucity of information on how and when lithium is used by pregnant women.ObjectiveTo examine lithium use in the perinatal period.Design, Setting, and ParticipantsThis cohort study used individual-level data of pregnancies from January 1, 2000, to December 31, 2021, in Australia, Denmark, Finland, Germany, Hong Kong, Iceland, Israel, New Zealand, Norway, South Korea, Sweden, Taiwan, the UK, and 2 cohorts in the US. Analyses were performed from September 1 to November 30, 2023.ExposuresThe prevalence of lithium use as the proportion of pregnancies with at least 1 prescription fill or prescription within 3 months before pregnancy until childbirth was estimated using a common protocol. Lithium use during pregnancy by trimester and in the 3 months before and after pregnancy was examined.Main Outcomes and MeasuresComparison of prevalence between the first and last 3-year periods of available data.ResultsAmong 21 659 454 pregnancies from all collaborating sites, the prevalence of lithium use ranged from 0.07 per 1000 pregnancies in Hong Kong to 1.56 per 1000 in the US publicly insured population. Lithium use increased per 1000 pregnancies in 10 populations (Australia [0.60 to 0.74], Denmark [0.09 to 0.51], Finland [0.10 to 0.29], Iceland [0.24 to 0.99], Israel [0.25 to 0.37], Norway [0.24 to 0.47], South Korea [0.30 to 0.44], Sweden [0.42 to 1.07], the UK [0.07 to 0.10], and Taiwan [0.15 to 0.19]), remained stable in 4 populations (Germany [0.17 to 0.16], Hong Kong [0.06 to 0.06], and the publicly [1.50 to 1.34] and commercially [0.38 to 0.36] insured US populations), and decreased in 1 population (New Zealand [0.54 to 0.39]). Use of lithium decreased with each trimester of pregnancy, while prevalence of postpartum use was similar to prepregnancy levels. The proportion of lithium use in the second trimester compared with the prepregnancy period ranged from 2% in South Korea to 80% in Denmark.Conclusions and RelevancePrevalence of lithium use in pregnant women over the past 2 decades varied markedly between populations. Patterns of use before, during, and after pregnancy suggest that many women discontinued lithium use during pregnancy and reinitiated treatment after childbirth, with large variations between countries. These findings underscore the need for internationally harmonized guidelines, specifically for psychiatric conditions among pregnant women that may benefit from lithium treatment.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Ueda2024,

title = {GLP-1 Receptor Agonist Use and Risk of Suicide Death},

author = {Peter Ueda and Jonas Söderling and Viktor Wintzell and Henrik Svanström and Laura Pazzagli and Björn Eliasson and Mads Melbye and Anders Hviid and Björn Pasternak},

doi = {10.1001/jamainternmed.2024.4369},

issn = {2168-6106},

year  = {2024},

date = {2024-11-01},

journal = {JAMA Intern Med},

volume = {184},

number = {11},

publisher = {American Medical Association (AMA)},

abstract = {ImportanceConcerns have been raised regarding a link between use of glucagon-like peptide-1 (GLP-1) receptor agonists and increased risk of suicidality and self-harm.ObjectiveTo assess the association between use of GLP-1 receptor agonists and the risk of suicide death in routine clinical practice.Design, Setting, and ParticipantsThis active-comparator new-user cohort study used nationwide register data from Sweden and Denmark from 2013 to 2021. Adults 18 to 84 years old who initiated treatment with GLP-1 receptor agonists or the comparator sodium-glucose cotransporter-2 (SGLT2) inhibitors were included. Data were analyzed from March to June 2024.ExposureInitiation of treatment with a GLP-1 receptor agonist or SGLT2 inhibitor.Main Outcomes and MeasuresThe primary outcome was suicide death recorded in the cause of death registers. Secondary outcomes were the composite of suicide death and nonfatal self-harm and the composite of incident depression and anxiety-related disorders. Using propensity score weighting, hazard ratios (HRs) with 95% CIs were calculated separately in the 2 countries and pooled in a meta-analysis.ResultsIn total, 124 517 adults initiated a GLP-1 receptor agonist and 174 036 initiated an SGLT2 inhibitor; among GLP-1 receptor agonist users, the mean (SD) age was 60 (13) years, and 45% were women. During a mean (SD) follow-up of 2.5 (1.7) years, 77 suicide deaths occurred among users of GLP-1 receptor agonists and 71 suicide deaths occurred among users of SGLT2 inhibitors: weighted incidences were 0.23 vs 0.18 events per 1000 person-years (HR, 1.25; 95% CI, 0.83-1.88), with an absolute difference of 0.05 (95% CI, −0.03 to 0.16) events per 1000 person-years. The HR was 0.83 (95% CI, 0.70-0.97) for suicide death and nonfatal self-harm, and the HR was 1.01 (95% CI, 0.97-1.06) for incident depression and anxiety-related disorders.Conclusions and RelevanceThis cohort study, including mostly patients with type 2 diabetes, does not show an association between use of GLP-1 receptor agonists and an increased risk of suicide death, self-harm, or incident depression and anxiety-related disorders. Suicide death among GLP-1 receptor agonist users was rare, and the upper limit of the confidence interval was compatible with an absolute risk increase of no more than 0.16 events per 1000 person-years.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Rasmussen2024,

title = {Early uptake of semaglutide for type 2 diabetes in Scandinavia and characteristics of initiators in Denmark: A register‐based drug utilization study},

author = {Lotte Rasmussen and Jacob Harbo Andersen and Øystein Karlstad and Diego Hernan Giunta and Marie Linder and Kari Furu and Anton Pottegård},

doi = {10.1111/dom.15876},

issn = {1463-1326},

year  = {2024},

date = {2024-11-00},

journal = {Diabetes Obesity Metabolism},

volume = {26},

number = {11},

pages = {5479--5482},

publisher = {Wiley},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Bliddal2024,

title = {Comparison of sociodemographic factors, healthcare utilisation by general practitioner visits, somatic hospital admissions, and medication use in Norway, Sweden, and Denmark},

author = {Mette Bliddal and Emma Bjørk and Øystein Karlstad and Jonas W. Wastesson and Rikke Wesselhoeft and Rune Lindahl-Jacobsen and Anton Pottegård and Maarten Jan Wensink and Lotte Rasmussen},

doi = {10.1016/j.annepidem.2024.07.004},

issn = {1047-2797},

year  = {2024},

date = {2024-10-00},

journal = {Annals of Epidemiology},

volume = {98},

pages = {1--7},

publisher = {Elsevier BV},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Razaz2024,

title = {Risk of Perinatal and Maternal Morbidity and Mortality Among Pregnant Women With Epilepsy},

author = {Neda Razaz and Jannicke Igland and Marte-Helene Bjørk and K. S. Joseph and Julie Werenberg Dreier and Nils Erik Gilhus and Mika Gissler and Maarit K. Leinonen and Helga Zoega and Silje Alvestad and Jakob Christensen and Torbjörn Tomson},

doi = {10.1001/jamaneurol.2024.2375},

issn = {2168-6149},

year  = {2024},

date = {2024-09-01},

journal = {JAMA Neurol},

volume = {81},

number = {9},

publisher = {American Medical Association (AMA)},

abstract = {ImportanceMaternal epilepsy is associated with adverse pregnancy and neonatal outcomes. A better understanding of this condition and the associated risk of mortality and morbidity at the time of delivery could help reduce adverse outcomes.ObjectiveTo determine the risk of severe maternal and perinatal morbidity and mortality among women with epilepsy.Design, Setting, ParticipantsThis prospective population-based register study in Denmark, Finland, Iceland, Norway, and Sweden took place between January 1, 1996, and December 31, 2017. Data analysis was performed from August 2022 to November 2023. Participants included all singleton births at 22 weeks’ gestation or longer. Births with missing or invalid information on birth weight or gestational length were excluded. The study team identified 4 511 267 deliveries, of which 4 475 984 were to women without epilepsy and 35 283 to mothers with epilepsy.ExposureMaternal epilepsy diagnosis recorded before childbirth. Prenatal exposure to antiseizure medication (ASM), defined as any maternal prescription fills from conception to childbirth, was also examined.Main outcomes and measuresComposite severe maternal morbidity and mortality occurring in pregnancy or within 42 days postpartum and composite severe neonatal morbidity (eg, neonatal convulsions) and perinatal mortality (ie, stillbirths and deaths) during the first 28 days of life. Multivariable generalized estimating equations with logit-link were used to obtain adjusted odds ratios (aORs) and 95% CIs.ResultsThe mean (SD) age at delivery for women in the epilepsy cohort was 29.9 (5.3) years. The rate of composite severe maternal morbidity and mortality was also higher in women with epilepsy compared with those without epilepsy (36.9 vs 25.4 per 1000 deliveries). Women with epilepsy also had a significantly higher risk of death (0.23 deaths per 1000 deliveries) compared with women without epilepsy (0.05 deaths per 1000 deliveries) with an aOR of 3.86 (95% CI, 1.48-8.10). In particular, maternal epilepsy was associated with increased odds of severe preeclampsia, embolism, disseminated intravascular coagulation or shock, cerebrovascular events, and severe mental health conditions. Fetuses and infants of women with epilepsy were at elevated odds of mortality (aOR, 1.20; 95% CI, 1.05-1.38) and severe neonatal morbidity (aOR, 1.48; 95% CI, 1.40-1.56). In analyses restricted to women with epilepsy, women exposed to ASM compared with those unexposed had higher odds of severe maternal morbidity (aOR ,1.24; 95% CI, 1.10-1.48) and their neonates had an increased odd of mortality and severe morbidity (aOR, 1.37; 95% CI, 1.23-1.52).Conclusion and relevanceThis multinational study shows that women with epilepsy were at considerably higher risk of severe maternal and perinatal outcomes and increased risk of death during pregnancy and postpartum. Maternal epilepsy and maternal use of ASM were associated with increased maternal morbidity and perinatal mortality and morbidity.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Ankarfeldt2024,

title = {Effectiveness of Baricitinib Risk Minimization Activities in Patients With Rheumatoid Arthritis—A Cohort Study in Four Nordic Countries},

author = {Mikkel Z. Ankarfeldt and Aleksander Søltoft‐Jensen and Claudia A. Salinas and Angela Lupattelli and Eero Pukkala and Kristian Bolin and Sarah Smith and Kristin Joy Meyers and Janne Petersen and Espen Jimenez‐Solem},

doi = {10.1002/pds.70010},

issn = {1099-1557},

year  = {2024},

date = {2024-09-00},

journal = {Pharmacoepidemiology and Drug},

volume = {33},

number = {9},

publisher = {Wiley},

abstract = {ABSTRACTIntroductionBaricitinib received European Medicines Agency (EMA) approval for the treatment of moderate‐to‐severe active rheumatoid arthritis (RA) in 2017. Due to risks including serious infections, increased blood lipid parameters, and missing information regarding safety in pregnancy, additional risk minimization measures (aRMM) including healthcare professional educational material and a patient alert card were implemented to inform on the risks and actions to minimize risk such as the need to screen for tuberculosis and active viral hepatitis before starting baricitinib, monitoring of blood lipids and against use during pregnancy. The aim of the study is to report occurrences of infections, lipid level monitoring and pregnancies, in real world data, to gain insights into whether baricitinib is used in accordance with the aRMM.MethodsA descriptive observational cohort study, utilizing routinely collected data from the Swedish, Norwegian, Finnish, and Danish national registries, was carried out. RA patients initiating baricitinib treatment were identified in the periods 2017–19 (Sweden and Finland), 2017–20 (Norway) and 2017–21 (Denmark). Monitored events included pregnancies, cases of tuberculosis, viral hepatitis, and hyperlipidemia, as well as changes in statin prescriptions (including any of initiation, escalation, reduction or change of statin). Hyperlipidemia and statin use served as proxies for lipid level assessment.ResultsAmong 3908 patients initiating baricitinib (3373 person‐years exposure), eight pregnancies (1% of 815 women aged 18–50 years) potentially overlapped with treatment. During baricitinib treatment, there was a small number of prevalent cases of tuberculosis (less than three events), and a low prevalence of hepatitis (0.2%), and hyperlipidemia (0.5%), whereas 9.3% had start of or changes in statin prescription, indicating lipid level monitoring.ConclusionThe study's findings suggest that patients with RA are treated with baricitinib in accordance with the risk minimization recommendations, particularly concerning pregnancy and infection risks. However, the methods used for assessing lipid levels warrant further refinement for more accurate monitoring.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Engström2024,

title = {Comparative cardiovascular and renal effectiveness of empagliflozin and dapagliflozin: Scandinavian cohort study},

author = {Arvid Engström and Jonas Söderling and Anders Hviid and Björn Eliasson and Soffia Gudbjörnsdottir and Viktor Wintzell and Kristian Hveem and Christian Jonasson and Mads Melbye and Björn Pasternak and Peter Ueda},

doi = {10.1093/ehjcvp/pvae045},

issn = {2055-6845},

year  = {2024},

date = {2024-08-14},

volume = {10},

number = {5},

pages = {432--443},

publisher = {Oxford University Press (OUP)},

abstract = {Abstract

               

                  Aims

                  To assess the comparative cardiovascular and renal effectiveness and safety of empagliflozin vs. dapagliflozin among patients with type 2 diabetes in routine clinical practice.

               

               

                  Methods and results

                  Cohort study using data from nationwide registers in Sweden, Denmark, and Norway, from June 2014 to June 2021 included 141 065 new users of empagliflozin and 58 306 new users of dapagliflozin. Coprimary outcomes were major cardiovascular events (myocardial infarction, stroke, and cardiovascular death), heart failure (hospitalization or death because of heart failure) and serious renal events (renal replacement therapy, hospitalization for renal events, and death from renal causes). Secondary outcomes were the individual components of the primary outcomes, any cause death, and diabetic ketoacidosis. Use of empagliflozin vs. dapagliflozin was associated with similar risk of major cardiovascular events [adjusted incidence rate: 15.9 vs. 15.8 events per 1000 person-years; HR 1.02, (95% confidence interval 0.97–1.08)], heart failure [6.5 vs. 6.3 events per 1000 person-years; HR 1.05 (0.97–1.14)] and serious renal events [3.7 vs. 4.1 events per 1000 person-years; HR 0.97 (0.87–1.07)]. In secondary outcome analyses, the HRs for use of empagliflozin vs. dapagliflozin were 1.00 (0.93–1.07) for myocardial infarction, 1.03 (0.95–1.12) for stroke, 1.01 (0.92–1.13) for cardiovascular death, 1.06 (1.00–1.11) for any cause death, 0.77 (0.60–0.99) for renal replacement therapy, 1.20 (0.75–1.93) for renal death, 1.01 (0.90–1.12) for hospitalization for renal events and 1.12 (0.94–1.33) for diabetic ketoacidosis.

               

               

                  Conclusion

                  Use of empagliflozin and dapagliflozin was associated with similar risk of cardiovascular and renal outcomes, mortality, and diabetic ketoacidosis.

               },

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Pedersen2024,

title = {Drug utilisation in children and adolescents before and after the start of the COVID‐19 pandemic: Interrupted time‐series analyses in three European countries},

author = {Elisabeth Pedersen and Elena Tripodi and Mia Aakjær and Huiqi Li and Anna Cantarutti and Fredrik Nyberg and Morten Andersen and Angela Lupattelli and Hedvig Nordeng},

doi = {10.1111/ppe.13046},

issn = {1365-3016},

year  = {2024},

date = {2024-08-00},

journal = {Paediatric Perinatal Epid},

volume = {38},

number = {6},

pages = {450--460},

publisher = {Wiley},

abstract = {AbstractBackgroundThe COVID‐19 pandemic has affected children and adolescents in several ways, including worsened mental health, improvement of asthma, and increases in diabetes ketoacidosis. Less is known about how medication use in children and adolescents has been affected by the pandemic.ObjectivesTo explore how the COVID‐19 pandemic affected drug utilisation in children and adolescents in Norway, Sweden, and Italy, by child age.MethodsWe conducted a longitudinal drug utilisation study among all children and adolescents (<18 years old) in Norway and Sweden and a nationwide paediatric database covering 3% of the paediatric population in Italy. We conducted an interrupted time‐series analysis from January 2018 to December 2021, with March 2020 as the interruption point. Dispensing or prescription rates of antidepressants, anxiolytics, sleep medications, attention‐deficit/hyperactivity disorder (ADHD) medications, insulin, and asthma medications were examined.ResultsThe study population in January 2018 consisted of 3,455,521 children and adolescents (136,188 from Italy, 1,160,431 from Norway, and 2,158,902 from Sweden). For sleep medications and insulin, there were only minor changes in level or trend in some age groups after March 2020. For asthma medications, the pandemic was associated with an immediate decrease in dispensing in Norway and Sweden (range of change in level: −19.2 to −3.7 dispensings per 1000 person‐months), and an increasing trend in all countries afterward (range of change in trend: 0.3–6.4 dispensings per 1000 person‐months), especially for the youngest age groups. Among adolescents, the pandemic was associated with an increased trend for ADHD medications, antidepressants, and anxiolytics in Norway and Sweden, but not in Italy.ConclusionsThe increasing trend of psychotropic medication dispensing, especially among adolescents after the start of the pandemic, is concerning and should be investigated further. Aside from a temporary effect on asthma medication dispensing, the pandemic did not greatly affect the dispensing of the medications investigated.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Leinonen2024,

title = {Socioeconomic differences in use of antiseizure medication in pregnancies with maternal epilepsy: A population‐based study from Nordic universal health care systems},

author = {Maarit K. Leinonen and Jannicke Igland and Julie Werenberg Dreier and Silje Alvestad and Jacqueline M. Cohen and Nils Erik Gilhus and Mika Gissler and Yuelian Sun and Torbjörn Tomson and Helga Zoega and Håkon M. Vegrim and Jakob Christensen and Marte‐Helene Bjørk},

doi = {10.1111/epi.18022},

issn = {1528-1167},

year  = {2024},

date = {2024-08-00},

journal = {Epilepsia},

volume = {65},

number = {8},

pages = {2397--2411},

publisher = {Wiley},

abstract = {AbstractObjectiveResearch points to disparities in disease burden and access to medical care in epilepsy. We studied the association between socioeconomic status (SES) and antiseizure medication (ASM) use in pregnancies with maternal epilepsy.MethodsWe conducted a cross‐sectional study consisting of 21 130 pregnancies with maternal epilepsy identified from Nordic registers during 2006–2017. SES indicators included cohabitation status, migrant background, educational attainment, and household income. Main outcomes were the proportion and patterns of ASM use from 90 days before pregnancy to birth. We applied multiple imputation to handle SES variables with 2%–4% missingness. We estimated adjusted risk ratios (aRRs) and 95% confidence intervals (CIs) using modified Poisson regression with the highest SES category as reference.ResultsMothers with the highest education and the highest income quintile used ASMs least frequently (56% and 53%, respectively). We observed increased risks of ASM discontinuation prior to or during the first trimester for low SES. The risk estimates varied depending on the SES indicator from aRR = 1.27 for low income (95% CI: 1.03–1.57) to aRR = 1.66 for low education (95% CI: 1.30–2.13). Migrant background was associated with ASM initiation after the first trimester (aRR 2.17; 95% CI 1.88–2.52). Low education was associated with the use of valproate during pregnancy in monotherapy (aRR 1.70; 95% CI 1.29–2.24) and in polytherapy (aRR 2.65; 95% CI 1.66–4.21). Low education was also associated with a 37% to 39% increased risk of switching from one ASM to another depending on the ASM used. For the other SES indicators, aRRs of switching varied from 1.16 (foreign origin; 95% CI 1.08–1.26) to 1.26 (not married or cohabiting; 95% CI 1.17–1.36).SignificanceLow SES was associated with riskier patterns of ASM use: discontinuation, late initiation, and switching during pregnancy. These findings may reflect unplanned pregnancies, disparities in access to preconception counseling, and suboptimal care.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Karlsson2024,

title = {Pregnancy and Infant Outcomes After Prenatal Exposure to Golimumab in Denmark, Finland, and Sweden 2006–2019},

author = {Pär Karlsson and Karin Gembert and Suzan Esslinger and Anja Geldhof and Mika Gissler and Maarit K. Leinonen and Marijo Otero‐Lobato and Lars Pedersen and Carolyn E. Cesta},

doi = {10.1002/pds.5878},

issn = {1099-1557},

year  = {2024},

date = {2024-08-00},

journal = {Pharmacoepidemiology and Drug},

volume = {33},

number = {8},

publisher = {Wiley},

abstract = {ABSTRACTPurposeTo present the main findings of a post‐authorization safety study assessing pregnancy and infant outcomes after prenatal golimumab exposure in a real‐world setting.MethodsThis observational population‐based cohort study included data from pregnancies ending in 2006–2018 (Finland) or 2019 (Denmark, Sweden). Infants born to women with rheumatic diseases or ulcerative colitis diagnoses were identified. Based on prescription fills from 90 days prior to pregnancy until delivery, infants were assigned to one of the four drug‐exposure cohorts: golimumab, other anti‐TNF biologics, other biologics, and nonbiologic systemic therapy, and the general population. Prevalence of adverse pregnancy outcomes, mortality, diagnoses of major congenital anomalies (MCA), and inpatient infections in the infants' first year of life were assessed. Odds ratios and 95% CIs were calculated for MCA and infection.ResultsAmong 134 infants in the golimumab cohort, none were stillborn or died in the first year of life. MCA were diagnosed in 4.5% of the infants in the golimumab cohort, versus 6.8%, 10.9%, 5.5%, and 4.6% in the other anti‐TNF biologics, other biologics, nonbiologic systemic therapy and general population cohorts, respectively. Inpatient infections were diagnosed in 11% of golimumab‐exposed infants, compared with 9%–11% of infants in the other cohorts. Unadjusted and selected adjusted comparisons showed no association between prenatal golimumab exposure and MCA or infection compared with the other exposure cohorts or general population.ConclusionsThe number of infants with prenatal golimumab exposure was low, but results are reassuringly consistent with the evidence available for other anti‐TNF biologics. Continued monitoring is needed.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Moreno‐Martos2024,

title = {Impact of the early COVID‐19 pandemic on adult mental health‐related dispensed medications, hospitalizations and specialist outpatient visits in Norway and Sweden: Interrupted time series analysis},

author = {David Moreno‐Martos and Jing Zhao and Huiqi Li and Fredrik Nyberg and Ludvig Daae Bjørndal and Mohammadhossein Hajiebrahimi and Björn Wettermark and Mia Aakjær and Morten Andersen and Maurizio Sessa and Angela Lupattelli and Hedvig Nordeng and Daniel R. Morales},

doi = {10.1111/bcp.16044},

issn = {1365-2125},

year  = {2024},

date = {2024-07-00},

journal = {Brit J Clinical Pharma},

volume = {90},

number = {7},

pages = {1627--1636},

publisher = {Wiley},

abstract = {AimsNorway and Sweden had different early pandemic responses that may have impacted mental health management. The aim was to assess the impact of the early COVID‐19 pandemic on mental health‐related care.MethodsWe used national registries in Norway and Sweden (1 January 2018–31 December 2020) to define 2 cohorts: (i) general adult population; and (ii) mental health adult population. Interrupted times series regression analyses evaluated step and slope changes compared to prepandemic levels for monthly rates of medications (antidepressants, antipsychotics, anxiolytics, hypnotics/sedatives, lithium, opioid analgesics, psychostimulants), hospitalizations (for anxiety, bipolar, depressive/mood, eating and schizophrenia/delusional disorders) and specialist outpatient visits.ResultsIn Norway, immediate reductions occurred in the general population for medications (−12% antidepressants to −7% hypnotics/sedatives) except for antipsychotics; and hospitalizations (−33% anxiety disorders to −17% bipolar disorders). Increasing slope change occurred for all medications except psychostimulants (+1.1%/month hypnotics/sedatives to +1.7%/month antidepressants); and hospitalization for anxiety disorders (+5.5%/month), depressive/mood disorders (+1.7%/month) and schizophrenia/delusional disorders (+2%/month). In Sweden, immediate reductions occurred for antidepressants (−7%) and opioids (−10%) and depressive/mood disorder hospitalizations (−11%) only with increasing slope change in psychostimulant prescribing of (0.9%/month). In contrast to Norway, increasing slope changes occurred in specialist outpatient visits for depressive/mood disorders, eating disorders and schizophrenia/delusional disorders (+1.5, +1.9 and +2.3%/month, respectively). Similar changes occurred in the pre‐existing mental health cohorts.ConclusionDifferences in early COVID‐19 policy response may have contributed to differences in adult mental healthcare provision in Norway and Sweden.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Robijn2024,

title = {Smoking Cessation Pharmacotherapy Use in Pregnancy},

author = {Annelies L. Robijn and Duong T. Tran and Jacqueline M. Cohen and Sarah Donald and Carolyn E. Cesta and Kari Furu and Lianne Parkin and Sallie-Anne Pearson and Johan Reutfors and Helga Zoega and Nicholas Zwar and Alys Havard},

doi = {10.1001/jamanetworkopen.2024.19245},

issn = {2574-3805},

year  = {2024},

date = {2024-06-03},

journal = {JAMA Netw Open},

volume = {7},

number = {6},

publisher = {American Medical Association (AMA)},

abstract = {ImportanceSignificant evidence gaps exist regarding the safety of smoking cessation pharmacotherapies during pregnancy, especially for the risk of congenital malformations. Consequently, professional bodies advise against the use of varenicline and bupropion and recommend caution with nicotine replacement therapy (NRT). Contemporary estimates of the use of smoking cessation pharmacotherapies during pregnancy are lacking.ObjectiveTo quantify the proportion of individuals using prescribed smoking cessation pharmacotherapies during pregnancy and during the first trimester specifically, in 4 countries.Design, Setting, and ParticipantsThis retrospective, population-based cohort study used linked birth records, hospital admission records, and dispensing records of prescribed medications from all pregnancies resulting in birth between 2015 and 2020 in New South Wales, Australia; New Zealand; Norway; and Sweden. Data analyses were conducted in October and November 2023.ExposurePrescribed smoking cessation pharmacotherapy use (varenicline, NRT, and bupropion) during pregnancy was defined as days’ supply overlapping the period from date of conception to childbirth.Main Outcomes and MeasuresPrevalence of use among all pregnancies and pregnancies with maternal smoking were calculated. Among women who used a pharmacotherapy, the proportion of women with use during the first trimester of pregnancy was also calculated.ResultsAmong 1 700 638 pregnancies in 4 countries, 138 033 (8.1%) had maternal smoking and 729 498 (42.9%) were younger than 30 years. The prevalences ranged from 0.02% to 0.14% for varenicline, less than 0.01% to 1.86% for prescribed NRT, and less than 0.01% to 0.07% for bupropion. Among pregnant individuals who smoked, use of pharmacotherapies was up to 10 times higher, with maximum prevalences of 1.25% for varenicline in New South Wales, 11.39% for NRT in New Zealand, and 0.39% for bupropion in New Zealand. Use in the first trimester occurred among more than 90% of individuals using varenicline, approximately 60% among those using NRT, and 80% to 90% among those using bupropion.Conclusions and RelevanceIn this cohort study of pregnant individuals in 4 high-income countries, the low prevalence of varenicline and bupropion use during pregnancy and higher prevalence of NRT use aligned with current clinical guidelines. As most use occurred in the first trimester, there is a need for evidence on the risk of congenital malformations for these medications.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Ueda2024b,

title = {Use of DPP4 Inhibitors and GLP-1 Receptor Agonists and Risk of Intestinal Obstruction: Scandinavian Cohort Study},

author = {Peter Ueda and Viktor Wintzell and Mads Melbye and Björn Eliasson and Jonas Söderling and Soffia Gudbjörnsdottir and Kristian Hveem and Christian Jonasson and Henrik Svanström and Anders Hviid and Björn Pasternak},

doi = {10.1016/j.cgh.2023.08.034},

issn = {1542-3565},

year  = {2024},

date = {2024-06-00},

journal = {Clinical Gastroenterology and Hepatology},

volume = {22},

number = {6},

pages = {1226--1237.e14},

publisher = {Elsevier BV},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Chan2024,

title = {Maternal diabetes and risk of attention-deficit/hyperactivity disorder in offspring in a multinational cohort of 3.6 million mother–child pairs},

author = {Adrienne Y. L. Chan and Le Gao and Miyuki Hsing-Chun Hsieh and Lars J. Kjerpeseth and Raquel Avelar and Tobias Banaschewski and Amy Hai Yan Chan and David Coghill and Jacqueline M. Cohen and Mika Gissler and Jeff Harrison and Patrick Ip and Øystein Karlstad and Wallis C. Y. Lau and Maarit K. Leinonen and Wing Cheong Leung and Tzu-Chi Liao and Johan Reutfors and Shih-Chieh Shao and Emily Simonoff and Kathryn Choon Beng Tan and Katja Taxis and Andrew Tomlin and Carolyn E. Cesta and Edward Chia-Cheng Lai and Helga Zoega and Kenneth K. C. Man and Ian C. K. Wong},

doi = {10.1038/s41591-024-02917-8},

issn = {1546-170X},

year  = {2024},

date = {2024-05-00},

journal = {Nat Med},

volume = {30},

number = {5},

pages = {1416--1423},

publisher = {Springer Science and Business Media LLC},

abstract = {AbstractPrevious studies report an association between maternal diabetes mellitus (MDM) and attention-deficit/hyperactivity disorder (ADHD), often overlooking unmeasured confounders such as shared genetics and environmental factors. We therefore conducted a multinational cohort study with linked mother–child pairs data in Hong Kong, New Zealand, Taiwan, Finland, Iceland, Norway and Sweden to evaluate associations between different MDM (any MDM, gestational diabetes mellitus (GDM) and pregestational diabetes mellitus (PGDM)) and ADHD using Cox proportional hazards regression. We included over 3.6 million mother–child pairs between 2001 and 2014 with follow-up until 2020. Children who were born to mothers with any type of diabetes during pregnancy had a higher risk of ADHD than unexposed children (pooled hazard ratio (HR) = 1.16, 95% confidence interval (CI) = 1.08-1.24). Higher risks of ADHD were also observed for both GDM (pooled HR = 1.10, 95% CI = 1.04-1.17) and PGDM (pooled HR = 1.39, 95% CI = 1.25-1.55). However, siblings with discordant exposure to GDM in pregnancy had similar risks of ADHD (pooled HR = 1.05, 95% CI = 0.94-1.17), suggesting potential confounding by unmeasured, shared familial factors. Our findings indicate that there is a small-to-moderate association between MDM and ADHD, whereas the association between GDM and ADHD is unlikely to be causal. This finding contrast with previous studies, which reported substantially higher risk estimates, and underscores the need to reevaluate the precise roles of hyperglycemia and genetic factors in the relationship between MDM and ADHD.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Hviid2024,

title = {Booster vaccination with SARS-CoV-2 mRNA vaccines and myocarditis in adolescents and young adults: a Nordic cohort study},

author = {Anders Hviid and Tuomo A Nieminen and Nicklas Pihlström and Nina Gunnes and Jesper Dahl and Øystein Karlstad and Hanne Løvdal Gulseth and Anders Sundström and Anders Husby and Jørgen Vinsløv Hansen and Rickard Ljung and Petteri Hovi},

doi = {10.1093/eurheartj/ehae056},

issn = {1522-9645},

year  = {2024},

date = {2024-04-14},

volume = {45},

number = {15},

pages = {1327--1335},

publisher = {Oxford University Press (OUP)},

abstract = {Abstract

               

                  Background and Aims

                  The SARS-CoV-2 mRNA vaccines are associated with an increased risk of myocarditis. This association appears to be strongest in male adolescents and younger males and after the second dose. The aim was to evaluate the risk of myocarditis following SARS-CoV-2 mRNA booster vaccination in 12-to-39-year-olds.

               

               

                  Methods

                  A multinational cohort study was conducted using nationwide register data in Denmark, Finland, Norway, and Sweden and comprising all 8.9 million individuals residing in each of the four countries. Participants were followed for an inpatient diagnosis of myocarditis. In each of the four countries, Poisson regression was used to estimate adjusted incidence rate ratios (IRRs) of myocarditis comparing vaccination schedules, with associated 95% confidence intervals (CIs). Country-specific results were combined in meta-analyses.

               

               

                  Results

                  A total of 8.9 million residents were followed for 12 271 861 person-years and 1533 cases of myocarditis were identified. In 12-to-39-year-old males, the 28-day acute risk period following the third dose of BNT162b2 or mRNA-1273 was associated with an increased incidence rate of myocarditis compared to the post-acute risk period 28 days or more after the second dose [IRR 2.08 (95% CI 1.31–3.33) and 8.89 (2.26–35.03), respectively]. For females, the corresponding IRR was only estimable for BNT162b2, 3.99 (0.41–38.64). The corresponding absolute risks following the third dose of BNT162b2 and mRNA-1273 in males were 0.86 (95% CI 0.53–1.32) and 1.95 (0.53–4.99) myocarditis events within 28 days per 100 000 individuals vaccinated, respectively. In females, the corresponding absolute risks following the third dose of BNT162b2 were 0.15 (0.04–0.39) events per 100 000 individuals vaccinated. No deaths occurred within 30 days of vaccine-related cases.

               

               

                  Conclusions

                  The results suggest that a booster dose is associated with increased myocarditis risk in adolescents and young adults. However, the absolute risk of myocarditis following booster vaccination is low.

               },

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Pasternak2024,

title = {Glucagon-like peptide 1 receptor agonist use and risk of thyroid cancer: Scandinavian cohort study},

author = {Björn Pasternak and Viktor Wintzell and Anders Hviid and Björn Eliasson and Soffia Gudbjörnsdottir and Christian Jonasson and Kristian Hveem and Henrik Svanström and Mads Melbye and Peter Ueda},

doi = {10.1136/bmj-2023-078225},

issn = {1756-1833},

year  = {2024},

date = {2024-04-10},

journal = {BMJ},

publisher = {BMJ},

abstract = {Abstract

          

            Objective

            To investigate whether use of glucagon-like peptide 1 (GLP1) receptor agonists is associated with increased risk of thyroid cancer.

          

          

            Design

            Scandinavian cohort study.

          

          

            Setting

            Denmark, Norway, and Sweden, 2007-21.

          

          

            Participants

            Patients who started GLP1 receptor agonist treatment were compared with patients who started dipeptidyl peptidase 4 (DPP4) inhibitor treatment, and in an additional analysis, patients who started sodium-glucose cotransporter 2 (SGLT2) inhibitor treatment.

          

          

            Main outcome measures

            Thyroid cancer identified from nationwide cancer registers. An active-comparator new user study design was used to minimise risks of confounding and time related biases from using real world studies of drug effects. Cox regression was used to estimate hazard ratios, controlling for potential confounders with propensity score weighting.

          

          

            Results

            The mean follow-up time was 3.9 years (standard deviation 3.5 years) in the GLP1 receptor agonist group and 5.4 years (standard deviation 3.5 years) in the DPP4 inhibitor group. 76 of 145 410 patients (incidence rate 1.33 events per 10 000 person years) treated with GLP1 receptor agonists and 184 of 291 667 patients (incidence rate 1.46 events per 10 000 person years) treated with DPP4 inhibitors developed thyroid cancer. GLP1 receptor agonist use was not associated with increased risk of thyroid cancer (hazard ratio 0.93, 95% confidence interval 0.66 to 1.31; rate difference −0.13, 95% confidence interval −0.61 to 0.36 events per 10 000 person years). The hazard ratio for medullary thyroid cancer was 1.19 (0.37 to 3.86). In the additional analysis comparing the GLP1 receptor agonist group with the SGLT2 inhibitor group, the hazard ratio for thyroid cancer was 1.16 (0.65 to 2.05).

          

          

            Conclusions

            In this large cohort study using nationwide data from three countries, GLP1 receptor agonist use was not associated with a substantially increased risk of thyroid cancer over a mean follow-up of 3.9 years. In the main analysis comparing GLP1 receptor agonists with DPP4 inhibitors, the upper limit of the confidence interval was consistent with no more than a 31% increase in relative risk.

          },

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Bruno2024,

title = {Antipsychotic use during pregnancy and risk of specific neurodevelopmental disorders and learning difficulties in children: a multinational cohort study},

author = {Claudia Bruno and Carolyn E. Cesta and Vidar Hjellvik and Sinna Pilgaard Ulrichsen and Marte-Helene Bjørk and Buket Öztürk Esen and Malcolm B. Gillies and Mika Gissler and Alys Havard and Øystein Karlstad and Maarit K. Leinonen and Mette Nørgaard and Sallie-Anne Pearson and Johan Reutfors and Kari Furu and Jacqueline M. Cohen and Helga Zoega},

doi = {10.1016/j.eclinm.2024.102531},

issn = {2589-5370},

year  = {2024},

date = {2024-04-00},

journal = {eClinicalMedicine},

volume = {70},

publisher = {Elsevier BV},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Christensen2024,

title = {Prenatal exposure to antiseizure medications and fetal growth: a population-based cohort study from the Nordic countries},

author = {Jakob Christensen and Helga Zoega and Maarit K. Leinonen and Nils Erik Gilhus and Mika Gissler and Jannicke Igland and Yuelian Sun and Torbjörn Tomson and Silje Alvestad and Marte-Helene Bjørk and Julie Werenberg Dreier},

doi = {10.1016/j.lanepe.2024.100849},

issn = {2666-7762},

year  = {2024},

date = {2024-03-00},

journal = {The Lancet Regional Health - Europe},

volume = {38},

publisher = {Elsevier BV},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Dreier2024,

title = {Prenatal Exposure to Antiseizure Medications and Risk of Epilepsy in Children of Mothers With Epilepsy},

author = {Julie Werenberg Dreier and Jakob Christensen and Jannicke Igland and Mika Gissler and Maarit K. Leinonen and Håkon Magne Vegrim and Yuelian Sun and Torbjörn Tomson and Helga Zoega and Marte-Helene Bjørk and Rebecca L. Bromley},

doi = {10.1001/jamanetworkopen.2023.56425},

issn = {2574-3805},

year  = {2024},

date = {2024-02-05},

journal = {JAMA Netw Open},

volume = {7},

number = {2},

publisher = {American Medical Association (AMA)},

abstract = {ImportanceUse of valproate and certain other antiseizure medications (ASMs) in pregnancy is associated with abnormal fetal brain development with potential long-term implications for the child.ObjectiveTo examine whether use of valproate and other ASMs in pregnancy among mothers with epilepsy is associated with epilepsy risk in their children.Design, Setting, and ParticipantsThis prospective, population-based register cohort study included singletons born to mothers with epilepsy in Denmark, Finland, Iceland, Norway, and Sweden from January 1, 1996, to December 31, 2017. Data analysis was performed from October 2022 to December 2023.ExposureRedeemed prescription for an ASM from 30 days before pregnancy until birth.Main Outcomes and MeasuresThe main outcome was epilepsy in children, assessed usingInternational Statistical Classification of Diseases and Related Health Problems, Tenth Revisiondiagnoses from hospital care. Adjusted hazard ratios (AHRs) and 95% CIs were estimated using Cox proportional hazards regression. Secondary analyses included dose-response analyses, analyses using children of mothers who discontinued ASM prior to pregnancy as the reference, and sibling analyses.ResultsThis cohort study included 38 663 children of mothers with epilepsy (19 854 [51.4%] boys). Children were followed up from birth; the mean length of follow-up was 7.2 years (range 0-22 years). Compared with 22 207 children of mothers not using an ASM in pregnancy, increased risks of epilepsy in children of mothers who used valproate in pregnancy (monotherapy: AHR, 2.18; 95% CI, 1.70-2.79; polytherapy: AHR, 2.10; 95% CI, 1.49-2.96) were observed. However, there was no dose-dependent association, and there was a similar risk of epilepsy in siblings who were exposed and unexposed to valproate (AHR, 0.95; 95% CI, 0.50-1.82). Prenatal exposure to topiramate monotherapy was associated with increased risk of epilepsy (AHR, 2.32; 95% CI, 1.30-4.16), and the risk was greater for higher doses, but the risk attenuated in comparisons with children of mothers who discontinued topiramate before pregnancy (AHR, 1.19; 95% CI, 0.26-5.44). Prenatal exposure to clonazepam monotherapy was also associated with increased epilepsy risk (AHR, 1.90; 95% CI, 1.16-3.12), but limited follow-up and low numbers precluded further analyses. No associations were observed for prenatal exposure to lamotrigine (AHR, 1.18; 95% CI, 0.95-1.47), levetiracetam (AHR, 1.28; 95% CI, 0.77-2.14), carbamazepine (AHR, 1.13; 95% CI, 0.85-1.50), or oxcarbazepine (AHR, 0.68; 95% CI, 0.44-1.05).Conclusions and RelevanceIn this cohort study of children born to mothers with epilepsy, the associations found between prenatal exposure to certain ASMs and the child’s risk of epilepsy did not persist in sensitivity analyses, suggesting that maternal ASM use in pregnancy may not increase epilepsy risk in children beyond that associated with the maternal epilepsy itself. These findings are reassuring for women in need of treatment with ASM in pregnancy.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Brikell2024,

title = {ADHD medication discontinuation and persistence across the lifespan: a retrospective observational study using population-based databases},

author = {Isabell Brikell and Honghui Yao and Lin Li and Aske Astrup and Le Gao and Malcolm B Gillies and Tian Xie and Yanli Zhang-James and Søren Dalsgaard and Anders Engeland and Stephen V Faraone and Jan Haavik and Catharina Hartman and Patrick Ip and Unnur Jakobsdóttir Smári and Henrik Larsson and Kenneth KC Man and Juliana de Oliveira Costa and Sallie-Anne Pearson and Nina Pil Hostrup Nielsen and Harold Snieder and Theresa Wimberley and Ian CK Wong and Le Zhang and Helga Zoega and Kari Klungsøyr and Zheng Chang},

doi = {10.1016/s2215-0366(23)00332-2},

issn = {2215-0366},

year  = {2024},

date = {2024-01-00},

journal = {The Lancet Psychiatry},

volume = {11},

number = {1},

pages = {16--26},

publisher = {Elsevier BV},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Engström2023,

title = {Association of glucagon-like peptide-1 receptor agonists with serious liver events among patients with type 2 diabetes: A Scandinavian cohort study},

author = {Arvid Engström and Viktor Wintzell and Mads Melbye and Henrik Svanström and Björn Eliasson and Soffia Gudbjörnsdottir and Kristian Hveem and Christian Jonasson and Anders Hviid and Peter Ueda and Björn Pasternak},

doi = {10.1097/hep.0000000000000712},

issn = {0270-9139},

year  = {2024},

date = {2024-00-00},

volume = {79},

number = {6},

pages = {1401--1411},

publisher = {Ovid Technologies (Wolters Kluwer Health)},

abstract = {

            Background and Aims:

            Clinical trials suggest that glucagon-like peptide-1 (GLP-1) receptor agonists may have beneficial effects on NAFLD, but the impact on hard hepatic end points is unknown. We assessed the association between the use of GLP-1 receptor agonists and the risk of serious liver events in routine clinical practice.

          

          

            Approach and Results:

            Cohort study using data from nationwide registers in Sweden, Denmark, and Norway, 2007–2020, including 91,479 initiators of GLP-1 receptor agonists and 244,004 initiators of the active comparator, dipeptidyl peptidase-4 inhibitors, without a history of chronic liver disease other than NAFLD/NASH. The primary outcome was serious liver events: a composite of incident compensated and decompensated cirrhosis and HCC. Secondary outcomes were the individual components of the primary outcome. Cox regression was used to estimate HRs, using propensity score weighting to control for confounding. Users of GLP-1 receptor agonists had 608 serious liver events (adjusted incidence rate: 16.9 events per 10,000 person-years), compared with 1770 events among users of dipeptidyl peptidase-4 inhibitors (19.2 events per 10,000 person-years). The adjusted HR was 0.85 (95% CI: 0.75 to 0.97), and the rate difference was −2.1 (−4.4 to 0.1) events per 10,000 person-years. In secondary outcome analyses, the adjusted HR was 0.85 (0.75 to 0.97) for compensated and decompensated cirrhosis and 1.05 (0.80 to 1.39) for HCC.

          

          

            Conclusions:

            The use of GLP-1 receptor agonists was associated with a significantly reduced risk of serious liver events, driven by a reduction of compensated and decompensated cirrhosis.

          },

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid35831669,

title = {Trends in use of attention deficit hyperactivity disorder medication among children and adolescents in Scandinavia in 2010-2020},

author = {Anne Mette Skov Sørensen and Rikke Wesselhöeft and Jacob Harbo Andersen and Johan Reutfors and Carolyn E Cesta and Kari Furu and Ingeborg Hartz and Lotte Rasmussen},

doi = {10.1007/s00787-022-02034-2},

issn = {1435-165X},

year  = {2023},

date = {2023-10-01},

journal = {Eur Child Adolesc Psychiatry},

volume = {32},

number = {10},

pages = {2049--2056},

abstract = {The objective of the study was to compare the use of attention deficit hyperactivity disorder (ADHD) medication among children and adolescents in Scandinavia 2010-2020. Using aggregated prescription data for individuals aged 5-19 years, we calculated annual prevalence proportions of ADHD medication (users/1000 inhabitants) for each country, overall and stratified by age and sex. Overall, use of ADHD medication increased during 2010-2020 in all countries. The increase was pronounced in Sweden reaching 35 users/1000 inhabitants in 2020 (119% increase), whereas it reached 22/1000 in Denmark and Norway (equivalent to a 38% and 16% increase, respectively). Methylphenidate was the most frequently used drug and Sweden had the highest use reaching 25/1000 in 2020 compared to 16/1000 and 18/1000 in Denmark and Norway, respectively. Lisdexamfetamine use increased steadily and was also highest in Sweden (13/1000 in 2020). In 2020, atomoxetine use was higher in Sweden (4.6/1000) and Denmark (4.5/1000) compared to Norway (2.2/1000). From 2015, use of guanfacine increased in Sweden reaching 4.4/1000 in 2020 but remained low in Denmark (0.4/1000) and Norway (0.7/1000). Use of dexamphetamine was low (ranging from 0.47 to 0.75/1000 in 2020) in the three countries. ADHD medication use was highest in Sweden across all age groups. In all countries, the prevalence was higher in males compared to females. In conclusion, use of ADHD medication among children and adolescents in Scandinavia is increasing. The prevalence of use is higher in Sweden for all drug groups compared to Norway and Denmark.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid36433783,

title = {Comparative Safety of Antiseizure Medication Monotherapy for Major Malformations},

author = {Jacqueline M Cohen and Silje Alvestad and Carolyn E Cesta and Marte-Helene Bjørk and Maarit K Leinonen and Mette Nørgaard and Kristjana Einarsdóttir and Anders Engeland and Mika Gissler and Øystein Karlstad and Kari Klungsøyr and Ingvild Odsbu and Johan Reutfors and Randi M Selmer and Torbjörn Tomson and Sinna Pilgaard Ulrichsen and Helga Zoega and Kari Furu},

doi = {10.1002/ana.26561},

issn = {1531-8249},

year  = {2023},

date = {2023-03-01},

journal = {Ann Neurol},

volume = {93},

number = {3},

pages = {551--562},

abstract = {OBJECTIVE: This study was undertaken to examine the comparative safety of antiseizure medication (ASM) monotherapy in pregnancy with respect to risk of major congenital malformations (MCMs), overall and by MCM subtype.nnMETHODS: We conducted a population-based cohort study using national health register data from Denmark, Finland, Iceland, Norway, and Sweden (1996-2020). We compared pregnancies with first trimester exposure to lamotrigine monotherapy to ASM-unexposed, carbamazepine, valproate, oxcarbazepine, levetiracetam, and topiramate to lamotrigine monotherapy, and stratified monotherapy groups by dose. The outcome was nongenetic MCM and specific subtypes. We estimated adjusted risk ratios (aRRs) and 95% confidence intervals (CIs) with log-binomial regression and propensity score weights.nnRESULTS: There was a higher crude risk of any MCM in pregnancies exposed to lamotrigine monotherapy (n = 8,339) compared to ASM-unexposed pregnancies (n = 4,866,362), but not after confounder adjustment (aRR = 0.97, 95% CI = 0.87-1.08). Compared to lamotrigine, there was an increased risk of malformations associated with valproate (n = 2,031, aRR = 2.05, 95% CI = 1.70-2.46) and topiramate (n = 509, aRR = 1.81, 95% CI = 1.26-2.60), which increased in a dose-dependent manner. We found no differences in malformation risk for carbamazepine (n = 2,674, aRR = 0.91, 95% CI = 0.72-1.15), oxcarbazepine (n = 1,313, aRR = 1.09, 95% CI = 0.83-1.44), or levetiracetam (n = 1,040, aRR = 0.78, 95% CI = 0.53-1.13). Valproate was associated with several malformation subtypes, including nervous system, cardiac, oral clefts, clubfoot, and hypospadias, whereas lamotrigine and carbamazepine were not.nnINTERPRETATION: Topiramate is associated with an increased risk of MCM similar to that associated with valproate, but lower doses may mitigate the risks for both drugs. Conversely, we found no increased risks for lamotrigine, carbamazepine, oxcarbazepine, or levetiracetam, which is reassuring. ANN NEUROL 2023;93:551-562.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{pmid36442654,

title = {Utilization of antidepressants, anxiolytics, and hypnotics during the COVID-19 pandemic in Scandinavia},

author = {Mikael Tiger and Rikke Wesselhoeft and Pär Karlsson and Marte Handal and Mette Bliddal and Carolyn E Cesta and Svetlana Skurtveit and Johan Reutfors},

doi = {10.1016/j.jad.2022.11.068},

issn = {1573-2517},

year  = {2023},

date = {2023-02-01},

journal = {J Affect Disord},

volume = {323},

pages = {292--298},

abstract = {OBJECTIVE: To study patterns of antidepressant, anxiolytic, and hypnotic drug utilization in Denmark, Norway, and Sweden during the first year of the COVID-19 pandemic.nnMETHODS: The monthly observed number of prescription fills of antidepressants, benzodiazepines and benzodiazepine-related hypnotics (BZ), and other anxiolytics and hypnotics (OAH) per population in 2020 were compared with predicted numbers based on analysis of covariance of prescription fills during 2015-2019.nnRESULTS: In March 2020, there was an increased number of prescription fills for antidepressants, anxiolytics, and hypnotics in youths and adults aged 20-59 years in Denmark, Norway, and Sweden. Antidepressant prescription fills increased between 13.5 % and 31.3 % at the end of 2020 in all age groups in Denmark and 17.4 % in youths in Norway. BZ drug prescription fills increased by 20.8 % at the end of 2020 in the 20-59 year age group in Denmark and decreased by 16.7 % in youths in Sweden. A general increase of prescription fills of OAH at the end of 2020 was observed in all countries (range 24.0-80.0 % in Denmark, 11.5-30.8 % in Norway, and 9.1-12.1 % in Sweden). Increases of prescription fills of OAH occurred earlier in Denmark.nnLIMITATIONS: Aggregated data with lack of information on indications.nnCONCLUSIONS: Peaks of utilization of antidepressants, anxiolytics, and hypnotics observed in March 2020 may reflect medication stock piling. Increased antidepressant drug utilization in Denmark and in Norwegian youths together with the general increase in OAH utilization in the Scandinavian countries in late 2020 may indicate an increase of symptoms of depression and anxiety, as well as disturbed sleep.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}

@article{Huybrechts2023,

title = {Association of In Utero Antipsychotic Medication Exposure With Risk of Congenital Malformations in Nordic Countries and the US},

author = {Krista F. Huybrechts and Loreen Straub and Pär Karlsson and Laura Pazzagli and Kari Furu and Mika Gissler and Sonia Hernandez-Diaz and Mette Nørgaard and Helga Zoega and Brian T. Bateman and Carolyn E. Cesta and Jacqueline M. Cohen and Maarit K. Leinonen and Johan Reutfors and Randi M. Selmer and Elizabeth A. Suarez and Sinna Pilgaard Ulrichsen and Helle Kieler},

doi = {10.1001/jamapsychiatry.2022.4109},

issn = {2168-622X},

year  = {2023},

date = {2023-02-01},

journal = {JAMA Psychiatry},

volume = {80},

number = {2},

publisher = {American Medical Association (AMA)},

abstract = {ImportancePsychiatric disorders are common among female individuals of reproductive age. While antipsychotic medication use is increasing, the safety of such medications in pregnancy is an area with large evidence gaps.ObjectiveTo evaluate the risk of first-trimester antipsychotic exposure with respect to congenital malformations, focusing on individual drugs and specific malformation subtypes.Design, Setting, and ParticipantsThis cohort study used data from nationwide health registers from the 5 Nordic countries and the US and spanned 1996 to 2018. The Nordic cohort included all pregnancies resulting in singleton live-born infants, and the US cohort consisted of publicly insured mothers linked to their live-born infants nested in the nationwide Medicaid Analytic eXtract. Data were analyzed from November 2020 to April 2022.ExposuresOne or more first-trimester dispensing of any atypical, any typical, and individual antipsychotic drugs.Main Outcomes and MeasuresAny major congenital malformation and specific malformation subtypes previously suggested to be associated with antipsychotic exposure in utero: cardiovascular malformations, oral clefts, neural tube defects, hip dysplasia, limb reduction defects, anorectal atresia/stenosis, gastroschisis, hydrocephalus, other specific brain anomalies, and esophageal disorders. Propensity score stratification was used to control for potential confounders. Pooled adjusted estimates were calculated using indirect standardization.ResultsA total of 6 455 324 unexposed mothers (mean maternal age range across countries: 24-31 years), 21 751 mothers exposed to atypical antipsychotic drugs (mean age range, 26-31 years), and 6371 mothers exposed to typical antipsychotic drugs (mean age range, 27-32 years) were included in the study cohort. Prevalence of any major malformation was 2.7% (95% CI, 2.7%-2.8%) in unexposed infants, 4.3% (95% CI, 4.1%-4.6%) in infants with atypical antipsychotic drug exposure, and 3.1% (95% CI, 2.7%-3.5%) in infants with typical antipsychotic drug exposure in utero. Among the most prevalent exposure-outcome combinations, adjusted relative risks (aRR) were generally close to the null. One exception was olanzapine exposure and oral cleft (aRR, 2.1 [95% CI, 1.1-4.3]); however, estimates varied across sensitivity analyses. Among moderately prevalent combinations, increased risks were observed for gastroschisis and other specific brain anomalies after atypical antipsychotic exposure (aRR, 1.5 [95% CI, 0.8-2.6] and 1.9 [95% CI, 1.1-3.0]) and for cardiac malformations after chlorprothixene exposure (aRR, 1.6 [95% CI, 1.0-2.7]). While the association direction was consistent across sensitivity analyses, confidence intervals were wide, prohibiting firm conclusions.Conclusions and RelevanceIn this study, considering the evidence from primary and sensitivity analyses and inevitable statistical noise for very rare exposure-outcome combinations, in utero antipsychotic exposure generally was not meaningfully associated with an increased risk of malformations. The observed increased risks of oral clefts associated with olanzapine, gastroschisis, and other specific brain anomalies with atypical antipsychotics and cardiac malformations with chlorprothixene requires confirmation as evidence continues to accumulate.},

keywords = {},

pubstate = {published},

tppubtype = {article}

}