Drug Safety in Pregnancy: Data, Methods, and Challenges

This entry provides an overview of how drug safety research in pregnancy is conducted, the challenges faced when undertaking this type of work, and the elements to consider when designing a study and selecting a data source. Following the thalidomide tragedy in the 1960s, where babies were born with a range of major congenital malformations resulting from their mother’s use of thalidomide in the first trimester of pregnancy, more attention has been given to the potential for fetal exposure. Since then, several different approaches and types of data source have been developed and used for post-marketing surveillance. However, despite these, for many medicines, both old and new, the safety of their use during pregnancy and their potential impact on the fetus are still limited and are largely unknown.