EURO medi CAT: Safety of medication use in pregnancy

Objective / Background 1) animal studies are seriously limited in their ability to predict human teratogenesis. 2) pregnant women are excluded from pre-marketing clinical trials in humans. Aims In EURO medi CAT we aim to build a European system for reproductive safety evaluation: To identify systematically and comprehensively the possible adverse effects in pregnancy of drugs at the earliest possible stage post marketing. To monitor and evaluate European safety measures. Methods EURO medi CAT will cover at least 3.7 million births from1995 to 2010. This is essential for the study of rare outcomes (congenital anomalies and rare drug exposures. The size of the database on babies/ fetuses with anomalies and the detail and standardisation of the description and coding of anomalies allows associations between specific types of anomalies and specific drugs to be studied. EUROCAT includes data on terminations of pregnancy for fetal anomaly (TOPFA) following prenatal diagnosis. Results The resulting diversity in prescribing practice allows us to: - dissociate drug-related effects from disease - generalise and disseminate our findings across the European Union, impacting on practice. The data reflect the whole population. Information comes fromall women and all pregnancies, including all types of congenital anomalies and irrespective of medication use in pregnancy. Analysis is underway Conclusion / Discussion The EURO medi CAT surveillance system and the component national congenital anomaly registers aim to preven a disaster on the scale of thalidomide happening again by detecting problems at as early as possible.