Drug safety in pregnancy: the German Embryotox institute

Abstract

Abstract Since 1988, the German Embryotox institute combinesindividual counselling of pregnant women and theirhealth care providers (HCP) with research on drug safety inpregnancy. In addition, Embryotox offers web-based informationwhich covers the most important and most frequentlyrequested pharmaceutical substances. In contrast to readymadedrug risk information in package leaflets and other productinformation, individual counselling considers differentclinical settings such as (1) looking for a drug of choice orplanning pregnancy under medication, (2) risk assessment of aparticular drug that has already been taken during an(unplanned) pregnancy and (3) evaluation of an adverse pregnancyoutcome in association with a particular medication.Using the three established developmental toxicants valproicacid, isotretinoin, and renin-angiotensin-aldosterone system(RAAS) inhibitors as an example, the need of detailed informationis illustrated. Through the risk communication process,pregnancy outcome data are routinely collected byEmbryotox. This approach uses the advantages of a preexistingcommunication structure and of dealing with motivatedresponders. Engagement in the treatment plan facilitatesreceiving reliable data on drug exposure as well as detailedfollow-up data. Based on these patient records, prospectivedatasets are evaluated in observational cohort studies in comparisonto non-exposed control cohorts. In addition, retrospectivedatasets received as suspected adverse drug reactionsfrom multiple German sources allow a screening for signalsof teratogenicity and distinct patterns of developmental toxicity.Clinical expertise in specialties such as teratology, paediatrics,embryology, obstetrics and human genetics are requiredto ensure high-quality assessment of drug safety in pregnancy.Keywords Pharmacovigilance . Pregnancy . Teratogens .Risk assessmen