CHICAGO--(BUSINESS WIRE)--National and international ultrasound societies are urging the Food and Drug Administration to remove the “black box” from ultrasound contrast agent (UCA) labels.

“UCAs are among the safest diagnostic imaging products available,” according to a Citizen Petition filed by the International Contrast Ultrasound Society (ICUS).

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.
“It is clear to all who work in the field on a daily basis that the black box harms patient care by misrepresenting risk and inappropriately deterring the use of UCAs when they are medically indicated,” said Dr. Steven Feinstein, Co-President of ICUS and Professor of Medicine at Rush University Medical Center in Chicago.

“There is now a strong consensus from across the adult and pediatric medical ultrasound community that ultrasound contrast agents are extremely safe and do not warrant boxed warnings,” he added.

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.

“We are disappointed that ‘black box warnings’ are still mandated for ultrasound contrast agents, despite extensive scientific research and practice demonstrating their safety,” according to Dr. Brian Coley, AIUM President, Professor of Medicine and Radiologist-in-Chief at Cincinnati Children’s Hospital.

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.

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