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."