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

WASHINGTON--(EON: Enhanced Online News)--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.”

source: Business Wire