Changes to Pregnancy and Lactation Risk Labeling for Prescription Drugs

Abstract

Safe medication use by women during pregnancy and lactation is an area of concern for women and their health care providers. In December 2014, the U.S. Food and Drug Administration (FDA) issued a final rule on new labeling changes, which go into effect in June 2015 and eliminate the current letter system of A-D, X. The new labeling will include a summary of risks to using the medication during pregnancy and lactation, and supporting data and relevant information to assist health care providers in counseling pregnant and lactating women.

Keywords: FDA; fetal risk; lactation; medication labeling; pregnancy.