Medications in pregnancy: Can we treat the mother while protecting the unborn?

With scores of new medications entering the market every year, the labeling for most of these drugs does not contain safety or efficacy data related to exposure during pregnancy. Yet, millions of pregnant women have disorders that require timely treatment, from chronic conditions such as epilepsy to pregnancy-induced conditions such as nausea and vomiting. The lack of knowledge in regard to maternal effectiveness and fetal safety of medications is a significant challenge for the practitioner, and exposes the mother to risk of insufficient therapy for her condition, and places her unborn baby at a potential risk of toxicity. The major task for the scientific community and regulators is to alter the clinical and policy environment which has left women and their unborn babies as therapeutic orphans. This chapter discusses the key elements of these challenges and offer practical solutions to close the knowledge gap.