Introduction to the EUROmediCAT project

Many women use medication during pregnancy. However, the safety of many medications for use in pregnancy has not been established at the time that the medication is licensed. Therefore, post-marketing surveillance of teratogenic effects in humans is essential. Pregnant women with long term or chronic diseases such as diabetes, epilepsy, asthma and depression need treatment during pregnancy, and safety information about the prescription medicine relating to these is a particular priority. Furthermore, as many pregnancies in Europe are unplanned, some drugs may be taken unintentionally during organogenesis before the pregnancy has been recognized, and safety issues related to such use need evaluation. To address these issues, it is important to build a systematic post-marketing surveillance system to evaluate safety of medicines in pregnancy so better information can be provided to health care professionals and patients. Congenital anomaly registries, which originated in the wake of the Thalidomide disaster with the aim of detecting a possible new teratogen at the earliest stage possible, are a crucial part of such a postmarketing surveillance system. The EUROmediCAT project is built on an existing network of congenital anomaly registries, the European Surveillance of Congenital Anomalies (EUROCAT) network. Innovative approaches are being tested to link congenital anomaly registries to exposed pregnancy cohorts, and to healthcare databases.