WASHINGTON–(BUSINESS WIRE)–International Contrast Ultrasound Society (ICUS) today applauded the
FDAs 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.
“The data shows that this can improve diagnostic accuracy
while lowering overall healthcare costs”
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 Lukes Mid-America Heart Institute in Kansas City.
Main said that although the
FDAs 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 FDAs 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 FDAs own standards for use of boxed warnings and stand in direct
opposition to the FDAs 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.
ABOUT ICUS: ICUS is an international, multi-disciplinary,
not-for-profit medical society that is exclusively dedicated to advancing the
use of contrast enhanced ultrasound diagnostic imaging to improve patient care
worldwide. Founded in September 2008, ICUS brings together physicians,
scientists, and other ultrasound imaging professionals from over 55 countries. ICUS
members represent diverse specialties such as cardiology, radiology, vascular
imaging, gastro-intestinal imaging, oncology, OB-GYN, and hepatology. For more
information about ICUS, please visit www.icus-society.org.
