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FRIMEDBIO-Fri prosj.st. med.,helse,biol

ADHD medication in pregnancy: understanding the population and outcomes related to treatment use and discontinuation

Alternative title: Bruk av ADHD legemidler i graviditeten: er bruk og seponering assosiert med en økt risiko for uheldige fødselsutfall?

Awarded: NOK 8.0 mill.

Our aim is to assess risks of ADHD medication use or discontinuation during pregnancy to advise health professionals and women of childbearing age with ADHD and provide scientific innovations. ADHD became an increasingly common diagnosis among adults in the last two decades. The subsequent increase in ADHD medication use among women of childbearing age has been substantial. While we are concerned about the potential negative consequences of drug exposures in pregnancy, we should also weigh the risks of discontinuing effective treatment. Prior epidemiologic studies have identified increased risks of miscarriage and preterm birth related to ADHD treatment, but there are concerns about what is the appropriate comparison group and potential sources of bias that have been underexplored. The primary objective of the project is to assess whether ADHD medication use or discontinuation during pregnancy increase the risk of miscarriage, preterm birth, or postpartum depression. The project uses data from health registries in Norway and Sweden and the Norwegian Mother, Father and Child Cohort Study (MoBa). We employ statistical methods that go beyond state of the art. The project is led by the Norwegian Institute of Public Health. A PhD student funded by RCN is employed in this project. Collaborating partners are Karolinska Institutet (Sweden), University of Bergen, University of British Columbia (Canada) and McGill University (Canada). We interviewed members of the patient organization "ADHD Norway" for input on relevant topics. In communication with the field, decision makers, health professionals and patient groups, we may influence regulations, clinical advice and promote research on the safe use of ADHD medicines during pregnancy.

ADHD became an increasingly common diagnosis among adults in the last two decades. The subsequent increase in ADHD medication use among women of childbearing age has been substantial. Evidence for the safety of ADHD medication in pregnancy must be generated from observational studies since clinical trials in pregnant women may be unethical. While we are concerned about the potential negative consequences of drug exposures in pregnancy, we should also weigh the risks of discontinuing effective treatment. Prior epidemiologic studies have identified increased risks of miscarriage and preterm birth related to ADHD treatment, but there are concerns about what is the appropriate comparison group and potential sources of bias that have been underexplored. The primary objective of the project is to assess whether ADHD medication use or discontinuation during pregnancy increase the risk of miscarriage, preterm birth, or postpartum depression. We will use information from several national health registries in Norway and Sweden and the large Norwegian Mother and Child Cohort Study (MoBa) to rigorously address fertility concerns and maternal and perinatal risks conferred by ADHD treatment and discontinuation of use in pregnancy. We will also investigate potential sources of bias, including whether women with ADHD are more likely to have an induced abortion, and whether drug exposures are likely to be misclassified due to discontinuation once a pregnancy is discovered. We will characterize trajectories of drug treatment and discontinuation surrounding pregnancy, and when the pregnancy may be vulnerable to adverse effects of treatment or discontinuation. The project will generate important new knowledge that will be used to provide guidance to public health professionals, clinicians treating women with ADHD who are pregnant or planning a pregnancy, and to advance the field of research on drug safety in pregnancy.

Funding scheme:

FRIMEDBIO-Fri prosj.st. med.,helse,biol

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