ICUS Applauds FDA Modification of Boxed Warnings on Certain Ultrasound Contrast Agents; Cite Patient Benefit

Washington, DC -- International Contrast Ultrasound Society (ICUS) today applauded the FDA’s decision to modify the U.S. product label for DEFINITY® Injectable Suspension, an ultrasound contrast agent. Ultrasound contrast agents are approved in the U.S. for cardiac imaging and do not expose patients to ionizing radiation.

ICUS, a cross-specialty society of international medical experts, filed a Citizen Petition with the FDA in September asking the agency to remove boxed warnings from ultrasound contrast agents, stating that the warnings deter use of a safe, inexpensive and radiation-free diagnostic imaging tool with potential life-saving benefits for patients.

“The FDA decision should lead to increased use of contrast, better imaging studies, better diagnosis for patients, and saved lives,” according to Dr. Michael Main, an expert in contrast ultrasound safety and Treasurer of ICUS. Main is a cardiologist and director of the echocardiography laboratory at Saint Luke’s Mid-America Heart Institute in Kansas City.

Main said that although the FDA’s current boxed warnings for ultrasound contrast agents are not warranted by safety data, the label modification for DEFINITY® “makes important incremental progress based on sound science that now more accurately reflects the risk benefit profile.”

"Based on all of the recent studies, without exception, we now know that ultrasound contrast agents are extremely safe and may be an excellent low cost alternative to other diagnostic procedures, including nuclear scans that expose patients to ionizing radiation," said Dr. Steven Feinstein, a cardiologist at Rush University Medical Center in Chicago and ICUS Co-President.

“The FDA’s action will reduce the chilling effect on use of ultrasound contrast agents,” Feinstein said.

“This will spare many patients from the cumulative effects of ionizing radiation that are inherent in certain alternative forms of diagnostic imaging, including SPECT and CT.” Ultrasound contrast agents do not expose patients to ionizing radiation, he said.

Feinstein said that by improving the clarity of front-line ultrasound scans, these contrast agents often help patients avoid more expensive and potentially riskier downstream testing. “The data shows that this can improve diagnostic accuracy while lowering overall healthcare costs,” he said.

The DEFINITY® label change was made after the FDA reviewed a 2010 proposed label change application from Lantheus Medical Imaging. The new product label no longer requires 30 minutes of monitoring after drug administration and notes that serious cardiopulmonary reactions are uncommon.

ICUS has long held that, given the strong safety profile of ultrasound contrast agents, boxed warnings on these products are inconsistent with the FDA’s own standards for use of boxed warnings and stand in direct opposition to the FDA’s statutory responsibility to protect the health of the American public. The September ICUS Citizen Petition also noted the available body of new safety data does not warrant the most serious level of caution - the boxed warning.

ICUS, which has members in 59 countries, represents cardiologists, radiologists, and other physicians and imaging professionals who use CEUS imaging.

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ICUS is the world’s only professional society exclusively devoted to contrast-enhanced ultrasound (CEUS) medical imaging technology.

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