About half of all pregnant women are prescribed medication during their pregnancy, including drugs with teratogenic potential. There is a need to manage teratogenic risk and prevent fetal harm. In the US, risk management strategies may range from product labeling to the US Food and Drug Administration requiring a risk evaluation and mitigation strategy, including elements to assure safe use. The resources of these risk management controls on the health care system must be weighed against the benefits of preventing embryo-fetal exposure and birth defects. This article describes considerations for determining which risk mitigation strategies to use with teratogenic drugs and the challenges and opportunities to balance restrictions and burdens with the benefit of access to important drugs.
Keywords: elements to assure safe use; pregnancy; risk evaluation and mitigation strategies; safety; teratogenic drugs.