In a new Citizen Petition filed by the International Contrast Ultrasound Society (ICUS) and other ultrasound societies, the groups are urging the Food and Drug Administration to remove the “black box” from ultrasound contrast agent (UCA) labels. UCAs are used worldwide to enhance diagnostic ultrasound scans, according to the Petition, which cited an extensive body of favorable safety data that was not available in 2007 when the boxed warnings were first mandated by the FDA.
According to the ICUS Petition, UCAs are injected into a patient’s arm vein during a diagnostic ultrasound scan to help diagnose heart disease, pinpoint and characterize cancers, monitor chronic gastro-intestinal diseases, detect vascular disease, evaluate other serious medical conditions and monitor therapy. By improving the reliability of real-time ultrasound scans, UCAs often reduce the need for unnecessary downstream tests and related costs, speed up the time to diagnosis and access to appropriate therapy, reduce the length of hospital stays, and improve patient care, outcomes and experiences.
Medical societies supporting the ICUS Petition include the American Institute of Ultrasound in Medicine (AIUM), the World Federation of Ultrasound in Medicine and Biology (WFUMB), the Society of Radiologists in Ultrasound (SRU), the Society of Diagnostic Medical Sonography (SDMS), the Society for Pediatric Radiology (SPR), the American Society of Echocardiography (ASE), and the Liver Imaging Reporting and Data System (LI-RADS) contrast-enhanced ultrasound (CEUS) working group. Numerous individual physicians also submitted letters supporting the ICUS Petition.
UCAs do not contain radioactive material or dye, present no known risk of kidney or liver damage, and do not require sedation. UCAs are metabolized and expelled from the body, primarily through the lungs, within minutes.
“Our collective experience shows that UCAs are exceedingly safe and beneficial, and they can change patient outcomes and improve patient experiences,” according to a statement submitted by the SRU on behalf of American radiologists with expertise in ultrasound.
The SRU statement added that CEUS is often “equivalent to or superior to CT and MRI, yet it is less expensive, more patient-friendly, more widely available, and completely radiation-free.”
According to the ICUS Petition, a “black box” warning is appropriate only as an indicator of the very highest level risk associated with FDA-approved products, and studies now show “no increased safety signal even among the sickest patients.” The Petition described safety studies undertaken after 2007 at the request of the FDA, as well as other independent studies recently published in peer-reviewed journals.
