Dermatologic drug safety in lactation

Abstract

In 2014, the US FDA removed the Pregnancy Category Drug lettering system and enacted the “Pregnancy and Lactation Label Ruling.” This ruling required drug products to contain contact information for drug-specific exposure pregnancy registries, narrative-style sections summarizing the known effect of pregnancy, lactation counseling data, and data describing risks for females and males of reproductive potential. This new ruling has added more dialogue and discussion to the patient-provider decision-making process and requires clinicians to provide more individualized counseling based on the current medical literature. This article summarizes the recent evidence for the safety of the most common dermatological therapies for pregnant and lactating women.