The International Contrast Ultrasound Society (ICUS) threw its support behind a proposed FDA label change that would affect the use of Optison, an ultrasound contrast agent marketed by GE Healthcare for use in contrast-enhanced ultrasound (CEUS) procedures.
ICUS said the proposed label modification is supported by a significant body of research demonstrating the safety, cost effectiveness and potential life-saving benefits of CEUS.
Support for the proposed label change is consistent with a citizen petition filed by the organization in October, according to ICUS. The citizen petition cited studies showing the superior safety profile of ultrasound contrast agents, along with their favorable risk-benefit ratios, in requesting removal of boxed warnings from both ultrasound contrast agents currently approved for use in the U.S.
"Based on newer studies showing the safety and diagnostic benefits of ultrasound contrast agents, we believe the current labeling is inconsistent with FDA standards for use of boxed warnings and stands in direct opposition to the FDA's statutory responsibility to protect the public's health," Steven B. Feinstein, MD, a cardiologist at Rush University Medical Center in Chicago and ICUS co-president, said in a statement.
"The key issue remains whether the available body of safety data warrants the most serious level of caution--the boxed warning--in the face of new scientific evidence," said Feinstein. "Pursuant to the FDA's own guidance, the answer is clear: Ultrasound contrast agents are exceedingly safe and do not warrant boxed warnings.”
Ultrasound contrast agents are approved in the U.S. for cardiac imaging only. Additional non-cardiac uses of CEUS are under review by the FDA, but throughout Europe, Canada, Asia and Brazil, CEUS is safely and routinely used to pinpoint cancers, monitor chronic gastro-intestinal diseases, detect vascular disease, as well as diagnose heart disease and serious medical conditions elsewhere in the body.