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Drug safety in pregnancy: the German Embryotox institute

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Abstract

Since 1988, the German Embryotox institute combines individual counselling of pregnant women and their health care providers (HCP) with research on drug safety in pregnancy. In addition, Embryotox offers web-based information which covers the most important and most frequently requested pharmaceutical substances. In contrast to ready-made drug risk information in package leaflets and other product information, individual counselling considers different clinical settings such as (1) looking for a drug of choice or planning pregnancy under medication, (2) risk assessment of a particular drug that has already been taken during an (unplanned) pregnancy and (3) evaluation of an adverse pregnancy outcome in association with a particular medication. Using the three established developmental toxicants valproic acid, isotretinoin, and renin-angiotensin-aldosterone system (RAAS) inhibitors as an example, the need of detailed information is illustrated. Through the risk communication process, pregnancy outcome data are routinely collected by Embryotox. This approach uses the advantages of a pre-existing communication structure and of dealing with motivated responders. Engagement in the treatment plan facilitates receiving reliable data on drug exposure as well as detailed follow-up data. Based on these patient records, prospective datasets are evaluated in observational cohort studies in comparison to non-exposed control cohorts. In addition, retrospective datasets received as suspected adverse drug reactions from multiple German sources allow a screening for signals of teratogenicity and distinct patterns of developmental toxicity. Clinical expertise in specialties such as teratology, paediatrics, embryology, obstetrics and human genetics are required to ensure high-quality assessment of drug safety in pregnancy.

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Acknowledgements

We would like to thank all the staff from the German Embryotox institute for the counselling, documentation, data handling and statistical data evaluation. We also thank L. Pritchard for the linguistic review.

Funding

Our institute is supported by the German Federal Institute for Drugs and Medical Devices (BfArM) and the Berlin health ministry.

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Authors and Affiliations

  1. Charité Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Pharmakovigilanz- und Beratungszentrum für Embryonaltoxikologie, Institut für Klinische Pharmakologie und Toxikologie, Augustenburger Platz 1, 13353, Berlin, Germany

    Katarina Dathe & Christof Schaefer

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  1. Katarina Dathe
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  2. Christof Schaefer
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Correspondence to Katarina Dathe.

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Dathe, K., Schaefer, C. Drug safety in pregnancy: the German Embryotox institute. Eur J Clin Pharmacol 74, 171–179 (2018). https://doi.org/10.1007/s00228-017-2351-y

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