Assessing the potential risk in drug prescriptions during pregnancy

Over eighty percent of pregnant women in the United States are prescribed at least one drug during pregnancy. The U.S. Food and Drug Administration (FDA) regulates the labeling of drug products and has established five risk categories for drug use during pregnancy. This classification was introduced in 1979. New FDA regulations (June 30, 2015) deeply revised the pregnancy and lactation labeling by eliminating these categories and replacing them with narrative summaries describing the risk of the drug and supporting evidence [1]. In a recent study on Medicaid data, 40% of pregnant women were dispensed at least one medication from categories D or X, for which there is positive evidence of human fetal risk [2]. In this work, our objective is to assess the potential risk in drug prescriptions during pregnancy, with respect to the new FDA standard. A secondary objective is to contrast risk assessment between the old FDA categories and the newly introduced narratives.