ICUS applauds FDA's decision to modify U.S. product label for OPTISON ultrasound contrast agent

The International Contrast Ultrasound Society (ICUS) today applauded the FDA's decision to modify the U.S. product label for OPTISON®, an ultrasound contrast agent used to improve the accuracy of radiation-free ultrasound scans. OPTISON® is marketed by GE Healthcare.    

The label change was supported by a Citizen Petition filed by ICUS in October, citing newer scientific studies showing the superior safety profile of ultrasound contrast agents along with their favorable risk-benefit ratios. The Citizen Petition, which was granted in part by the FDA last week, also supported a prior modification of the label for DEFINITY®, an ultrasound contrast agent marketed by Lantheus Medical Imaging.

The FDA's actions are "an important step forward for patients and for our health care system," said Dr. Steven Feinstein, a cardiologist at Rush University Medical Center in Chicago and ICUS Co-President.

Ultrasound contrast agents are administered intravenously during a noninvasive ultrasound scan to improve image clarity. The procedure does not expose patients to ionizing radiation, and ultrasound contrast agents do not contain dye or increase a patient's risk of nephrotoxicity, according to Dr. Feinstein.

"Ultrasound contrast agents are exceedingly safe and completely radiation-free diagnostic imaging tools," he said. "By improving the reliability of a simple front-line ultrasound scan, ultrasound contrast agents also may reduce the need for redundant, expensive and potentially riskier downstream testing - thereby improving patient care while also reducing the overall cost of diagnostic imaging."

The FDA's decision also 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, according to Dr. Michael Main, an expert in contrast ultrasound safety and Treasurer of ICUS. Dr. Main also is a cardiologist and director of the echocardiography laboratory at Saint Luke's Mid-America Heart Institute in Kansas City.

"The FDA decision should lead to increased use of contrast, better imaging studies, better diagnosis for patients, and saved lives," Dr. Main added.

Main said that although the FDA retained boxed warnings on both ultrasound contrast agents, newer safety data demonstrate a more favorable risk-benefit profile that ultimately may warrant additional label changes with removal of the boxed warnings.

"Still, the current label modification for OPTISON® represents significant progress based on sound scientific evidence and now more accurately reflects the risk benefit profile."