[Drug safety in pregnancy - the Embryotox project]

In many countries drug risk classifications tend to create the impression of a high level of risk, leading healthcare professionals and consumers to overestimate the actual risk when seeking a drug of choice or estimating the risk of a past exposure during pregnancy. In addition, there are insufficient human data for the majority of drugs used by women of reproductive age to precisely assess their prenatal risk or safety. The Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy provides pertinent information in this field to healthcare professionals and pregnant women. After the initiation of a risk inquiry exposed pregnancies are followed through as to birth outcome and beyond. These follow-up data allow the detection of signals and the quantification of safety or risks for the unborn through evaluation in prospective cohort studies. Both a detailed risk characterisation and/or quantification of safety are essential to risk management after inadvertent drug exposure or when looking for a drug of choice. Individual consultations are available drawing on the results from the institute's own database and other working groups, and regularly updated information is also available via the open access database www.embryotox.de.