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BEDREHELSE-Bedre helse og livskvalitet

International Pregnancy Drug Safety Studies (InPreSS). Short- and longer-term safety of drug use in pregnancy

Alternative title: International Pregnancy Drug Safety Studies (InPreSS). Kort- og langtidssikkerhet av legemiddelbruk under graviditet.

Awarded: NOK 13.3 mill.

Project Manager:

Project Number:

273366

Application Type:

Project Period:

2018 - 2024

InPreSS is an international collaboration (5 Nordic countries and USA, later also other countries included) to study safety of drug use in pregnancy. About 60% of Nordic pregnant women are prescribed drugs during pregnancy, some of them due to chronic diseases that necessitate long-term drug therapy also during the pregnancy. At the time of marketing of new drugs, limited knowledge on outcomes in children exposed to drugs in-utero exists, because pregnant women are not included in randomized trials of drugs. Further, knowledge concerning the health consequences for women with chronic illness, abstaining from their drugs during pregnancy is sparse. The overarching objective is to better understand the consequences of in-utero drug exposure for fetal development, birth defects and longer-term outcomes (neurodevelopment outcomes and academic performance) in the child, comparative drug safety, as well as maternal social and health consequences of discontinued drug treatment. We focused on treatments mainly used for chronic conditions, including but not limited to treatment of epilepsy, diabetes, ADHD and other psychiatric conditions. By combining multiple nationwide datasets from all five Nordic countries and in some of the studies also large-scale, representative data from the US, we have to studied in-utero drug exposures and rare outcomes not otherwise possible to examine in smaller datasets or in pre-marketing settings. The study population (about 5 million pregnant women) have been one of the largest pregnant populations linked to data on drug exposure to date and has sufficient power to answer the research questions. Inclusion of data from several countries and a rich data set of possible confounders will help generalizability of findings. Researchers at NIPH have worked closely with clinicians and excellent research environments in the Nordic countries, USA and Australia. Results have been presented at national and international conferences. As of December 2023, 22 articles published in scientific journals such as JAMA, JAMA Neurology, JAMA Psychiatry, Diabetes Care, Neurology, Acta Obstetricia et Gynecologica Scandinavia, Epidemiology, Schizophrenia Research and Pharmacoepidemiology and Drug Safety. We have arranged a 2-day conference with a focus on the treatment of epilepsy in pregnant women: Antiepileptic drugs in pregnancy and risk for the mother and child - an international conference. Researchers in InPreSS and other world-leading researchers from both Europe and the USA presented results from InPreSS and other international research and the consequences of these were discussed. The conference contributed to increase the knowledge and awareness of the consequences and challenges of using drugs in general and antiepileptic drugs in particular before and during pregnancy. The participants (200 from 17 countries / 5 continents) came from important target groups such as various clinical environments, research / universities, patient organizations and pharmacovigilance centers (international and Norwegian: SLV, RELIS, Trygg Mammamedisin). The benefits for the users (fertile women, Norwegian Medicine Agency and European Medicines Agency (EMA), Advisory Unit on Women's Health, and regional pharmacovigilance centers) have been updated knowledge and information on potential adverse effects of certain types of medication used during pregnancy, and a heightened awareness if adverse effects are found.

We have had several meetings with the Norwegian Medicine Agency (Legemiddelverket) where we have communicated findings from the studies even before they were published. Impact on regulatory decisions and guidelines: e.g. Our publication in JAMA Neurology 2022 leading to further restrictions by the European Medicine Agency (EMA) on topiramate (a drug used to treat epilepsy) use in pregnant women in the fall 2023 and a pregnancy prevention programme put in place. In letter to health personnel in Europe, three of our InPreSS publications on antiseizure drug exposure in pregnant women were cited. (https://www.ema.europa.eu/en/medicines/human/referrals/topiramate). In total, our results make an important contribution to the issue of safety in the use of medicines in pregnant women. Epidemiological studies of such a size are crucial and the only way that can give us more reliable knowledge about the consequences of drug use and higher precision in the risk estimates. The new knowledge will be important to different groups: healthy women of childbearing age (who are either pregnant or planning to be) and their partners, health personnel employed in various parts of the health system, who are responsible for the care and guidance of fertile women, regulatory authorities, and bodies responsible for giving advice on the use of medicines. We have increased our international research collaboration which in turn has led to new studies using the established data set and the common data model in InPreSS. Showcasing a positive impact on junior researcher careers: The two positions (postdoc and researcher) fully financed by InPreSS, secured permanent positions at NIPH.The researcher also managed to receive a Young Research Talent funding from RCN.

InPreSS is an international collaboration to study safety of drug use in pregnancy. About 60% of Nordic pregnant women are prescribed drugs during pregnancy, some of them due to chronic diseases that necessitate long-term drug therapy also during the pregnancy. At the time of marketing of new drugs, limited knowledge on outcomes in children exposed to drugs in-utero exists, because pregnant women are not included in randomized trials of drugs. Further, knowledge concerning the health consequences for women with chronic illness, abstaining from their drugs during pregnancy is sparse. It is urgent to investigate these issues. The overarching objective is to better understand the consequences of in-utero drug exposure for fetal development, birth defects and longer-term outcomes (neurodevelopment outcomes and academic performance) in the child, comparative drug safety, as well as maternal social and health consequences of discontinued drug treatment. We focus on treatments mainly used for chronic conditions, including but not limited to treatment of epilepsy, ADHD and other psychiatric conditions and severe acne. By combining multiple nationwide datasets from all five Nordic countries and large-scale, representative data from the US we aim to study in-utero drug exposures and rare outcomes not otherwise possible to examine in smaller datasets or in pre-marketing settings. The study population (about 5 million pregnant women) will be the largest pregnant population linked to data on drug exposure to date and has sufficient power to answer the research questions. The benefits for the users (fertile women, Norwegian Medicine Agency, Advisory Unit on Women's Health, and regional pharmacovigilance centers) will be new information on potential adverse effects of certain types of medication used during pregnancy, and a heightened awareness if adverse effects are found.

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Funding scheme:

BEDREHELSE-Bedre helse og livskvalitet