In Brief: Embryotoxicity REMS Removal for Endothelin Receptor Antagonists

The FDA has removed the Risk Evaluation and Mitigation Strategy (REMS) requirement for the endothelin receptor antagonists ambrisentan (Letairis, and generics), bosentan (Tracleer, and generics), macitentan (Opsumit, and generics; Opsynvi), and aprocitentan (Tryvio) and the endothelin receptor antagonist and angiotensin II receptor antagonist sparsentan (Filspari) that was initially implemented because of a possible risk of embryofetal toxicity.