Groups continue push for FDA to remove ‘black box’ warning from ultrasound contrast agents
March 06, 2019 – Radiology Business
By Michael Walter
The International Contrast Ultrasound Society (ICUS) is once again pushing the FDA to eliminate the “black box” warning from ultrasound contrast agents (UCAs), detailing its stance in a petition supported by several other medical societies. The ICUS also pushed the FDA to remove these warnings back in September 2018.
“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,” Steven B. Feinsten, MD, co-president of ICUS and a professor at Rush University Medical Center in Chicago, said in a prepared statement. “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.”
According to the ICUS, the black box warning is appropriate when FDA-approved products carry a significant risk, but research has shown that UCAs put patients at no such risk. Opponents of the warning believe it keeps some providers from using UCAs, potentially leading to patients not receiving the care they need.
“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,” Sharon L. Mulvagh, MD, professor of medicine emeritus at Mayo Clinic in Rochester, Minnesota, and professor of medicine at Dalhousie University in Halifax, Canada, said in the same statement.
Other societies supporting the ICUS petition include the American Institute of Ultrasound in Medicine, the World Federation of Ultrasound in Medicine and Biology, the Society of Radiologists in Ultrasound, the Society of Diagnostic Medical Sonography, the Society for Pediatric Radiology, the American Society of Echocardiography and the Liver Imaging Reporting and Data System contrast-enhanced ultrasound working group.