ASE Consensus Statement on Hypersensitivity Reactions to Ultrasound Enhancing Agents

Just over a week ago, the U.S. Food and Drug Administration (FDA) began notifying healthcare professionals that the ultrasound contrast agents Definity, Definity RT, and Lumason contain polyethylene glycol (PEG) and should not be administered to patients with known or suspected allergies to PEG. Since that time, ASE President Judy Hung, MD, FASE, composed a team of healthcare providers and scientists committed to the well-being of patients to develop a Consensus Statement that is in alignment with ASE’s mission to provide education that improves clinical outcomes.

This statement has been generated to provide our members and all practitioners of echocardiography with information and recommendations that will benefit the safety of patients receiving ultrasound enhancing agents (UEAs). Specifically, this document provides expert opinion on the clinical impact of the recent alert from MedWatch, the U.S. Food and Drug Administration (FDA) product safety reporting system, on presumed Type I immediate hypersensitivity reactions to the polyethylene glycol (PEG) component of UEAs.