CHICAGO--(BUSINESS WIRE)--International medical experts filed a Citizen Petition with the FDA urging the agency to remove boxed warnings from ultrasound contrast agents (UCAs) based on current highly favorable safety data and clinical experience.
According to the International Contrast Ultrasound Society (ICUS), UCAs are radiation-free diagnostic imaging agents that enhance the clarity and reliability of front-line ultrasound scans and often reduce the need for more expensive downstream testing. The Citizen Petition cited studies showing that UCAs are extremely safe -- and ultimately improve patient care, reduce overall health care costs, speed up the time to diagnosis and reduce the length of hospital stays.
UCAs are liquid suspensions of tiny gas-filled microbubbles that are injected into a patient’s arm vein during the ultrasound exam. As the UCA flows through the bloodstream, it reflects ultrasound waves in real time, helping physicians more accurately diagnose medical conditions and monitor therapy. According to the Citizen Petition, UCAs present no known risk of kidney or liver damage and are expelled from the body within minutes. In addition, patients do not require sedation during the contrast-enhanced ultrasound (CEUS) exam.
Three UCAs are currently approved for use in the United States -- Definity (Lantheus Medical Imaging), Lumason (Bracco) and Optison (GE Healthcare).
"The risk-benefit ratio for UCA use has dramatically changed since 2007, when the FDA first mandated the black box," according to cardiologist Mike Main of Saint Luke’s Mid America Heart Institute in Kansas City. Main is a Vice President of ICUS and the principal author of recent studies examining the safety of UCAs.
“Scientific data now consistently show that UCAs are extremely safe, and their benefits have been extended as a result of newly approved applications and use in larger patient populations,” Main added.
ICUS represents cardiologists, radiologists, and other physicians and imaging professionals in approximately 60 countries. The organization’s board recently voted to formally request FDA action on the black box warning.
“The boxed warnings are appropriate only as an indicator of the very highest level risk associated with FDA-approved products,” said Dr. Steven Feinstein, a cardiologist and professor of medicine at Rush University Medical Center in Chicago and ICUS Co-President. “This extreme level of risk is simply not presented by the use of UCAs, and ICUS is deeply concerned that the current boxed warnings unduly deter the use of UCAs when medically indicated -- to the detriment of our patients,” Feinstein added.
