The International Contrast Ultrasound Society (ICUS) urged the U.S. FDA to remove boxed warnings from ultrasound contrast agents based on research demonstrating its safety and clinical benefits, according to a press release from Sept. 17.
The ICUS—representing cardiologists, radiologists and other physicians and imaging professionals from 60 countries—voted to request action on the black box warning by filing a Citizen Petition with the FDA.
In the petition, the ICUS argued that ultrasound contrast agents (UCAs) are radiation-free, safe, may improve patient care and decrease patient costs. The petition states that UCAs present no known risk of kidney or liver damage and are expelled from the body within minutes without the need for sedation during the contrast-enhanced ultrasound (CEUS) exam, according to the release.
“The boxed warnings are appropriate only as an indicator of the very highest-level risk associated with FDA-approved products,” said Steven Feinstein, MD, co-president of ICUS and a cardiologist at Rush University Medical Center in Chicago, in a prepared statement. “This extreme level of risk is simply not presented by the use of UCAs, and ICUS is deeply concerned that the current boxed warnings unduly deter the use of UCAs when medically indicated—to the detriment of our patients.”
Three UCAs are approved in for use in the U.S. for cardiac and liver imaging in adults and children. Still, the ICUS believes the U.S. is behind in clinically using ultrasounds as UCAs are being used internationally to identify and monitor disease and cancers throughout the entire body.
Additionally, the petition recognizes the FDA’s steady effort to respond to evidence of safety and efficacy by downgrading package insert package insert contraindications three times since 2007 and removing a 30-minute monitoring requirement for patients with pulmonary hypertension or unstable cardiopulmonary conditions, according to the release.
"Now, with even more published research and clinical experience demonstrating the very strong safety profile and efficacy of UCAs, together with expanded UCA indications and patient populations for whom contrast enhanced ultrasound is clinically appropriate, it is time to remove the 'black box' entirely," according to Mike Main, MD, vice president of ICUS and a cardiologist at Saint Luke’s Mid America Heart Institute in Kansas City, Missouri.
A recent graduate from Dominican University (IL) with a bachelor’s in journalism, Melissa joined TriMed’s Chicago team in 2017 covering all aspects of health imaging. She’s a fan of singing and playing guitar, elephants, a good cup of tea, and her golden retriever Cooper.