UCAs are approved in the United States for cardiac and liver imaging in adults, and were recently also approved for use in children. But throughout Europe, Canada, Asia and Brazil UCAs are safely and routinely used to pinpoint cancers elsewhere in the body, monitor chronic gastro-intestinal diseases, detect vascular disease, as well as diagnose heart disease and other serious medical conditions.
“The United States is actually behind the rest of the world when it comes to using contrast-enhanced ultrasound,” according to Dr. Stephanie Wilson, Co-President of ICUS and Clinical Professor of Radiology at the University of Calgary. She said CEUS is very patient friendly, extremely reliable and easy to use.
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The Petition notes that the FDA has steadily responded to the mounting evidence of safety and efficacy by downgrading package insert contraindications three times since 2007 and removing a 30-minute monitoring requirement for patients with pulmonary hypertension or unstable cardiopulmonary conditions. More recently, the FDA approved new indications for use in additional patient populations.
According to the Citizen Petition, “The (published scientific) evidence more clearly supports a warning in the ‘warnings and precautions’ section, as the potential adverse reactions (namely, a serious allergic or anaphylactoid reaction or CARPA reaction) do not occur frequently enough to rise to the boxed warning standard.”
"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 CEUS is clinically appropriate, it is time to remove the 'black box' entirely," according to Main.
ABOUT ICUS:
The International Contrast Ultrasound Society (ICUS) is an international medical society dedicated to advancing the appropriate use of contrast enhanced ultrasound (CEUS) to improve patient care. ICUS members include physicians, scientists, and other ultrasound imaging professionals in approximately 60 countries.
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