Endothelin Receptor Antagonist REMS Information

https://www.fda.gov/drugs/information-drug-class/endothelin-receptor-antagonist-rems-information?utm_medium=email&utm_source=govdelivery FDA removes REMS requirements for embryofetal toxicity risk from all endothelin receptor antagonist medicines Based on a new analysis of human pregnancy data compiled about endothelin receptor antagonist (ERA) medicines for two decades, the U.S. Food and Drug Administration (FDA) has determined that risk evaluation and mitigation strategy (REMS) requirements for embryofetal toxicity (EFT) risk are no longer necessary to ensure the benefits of ERA medicines outweigh the risks. The Agency’s current assessment is that labeling alone is adequate to communicate the risk, and labeling will continue to inform health care professionals and patients of the risk.