March 06, 2019 – HealthImaging
By Matt O’Connor
The International Contrast Ultrasound Society (ICUS) is again urging the FDA to remove the “black box” warning from ultrasound contrast agent (UCA) labels, following its filing of a September 2018 citizen petition with 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 Steven Feinstein, co-president of ICUS and professor of medicine at Rush University Medical Center in Chicago, in an ICUS statement.
The boxed warnings were first mandated by the FDA in 2007, prior to the wealth of data now available demonstrating the safety of UCAs, according to the statement. For example, the ultrasound contrasts do not contain radioactive material or dye, have no known risk of kidney or liver damage and don’t necessitate sedation. Additionally, UCAs are expelled from the body in a matter of minutes.
A warning label is traditionally reserved for the very highest level risk associated with FDA-approved products, the petition suggests.
A host of ultrasound societies have backed the petition. They 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. Many individual physicians have also submitted letters in support of the ICUS.
“The unnecessary presence of a black box results in unfounded fears of utilization of these extremely beneficial agents, and patients are thus exposed to potentially more harmful investigative procedures, or worse, have no information due to uninterpretable, or misinterpreted ultrasound studies, resulting in missed or wrong diagnoses,” wrote Sharon Mulvagh, MD, of Mayo Clinic in Rochester, Minnesota.
The FDA has gradually taken action in response to the mounting evidence backing the safety of UCAs. It has downgraded package insert contraindications three times since 2007 and removed a 30-minute monitoring requirement for patients with pulmonary hypertension or unstable cardiopulmonary conditions, according to the statement. The FDA also recently approved new indications for use in adults and kids.
