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Medical Society Files FDA Citizen Petition Seeking Removal of Boxed Warnings on Ultrasound Contrast Agents

September 17, 2018

CHICAGO--(BUSINESS WIRE)--Sep 17, 2018--International medical experts filed a Citizen Petition with the FDA urging the agency to remove boxed warnings from ultrasound contrast agents (UCAs) based on current highly favorable safety data and clinical experience.

According to the International Contrast Ultrasound Society (ICUS), UCAs are radiation-free diagnostic imaging agents that enhance the clarity and reliability of front-line ultrasound scans and often reduce the need for more expensive downstream testing. The Citizen Petition cited studies showing that UCAs are extremely safe -- and ultimately improve patient care, reduce overall health care costs, speed up the time to diagnosis and reduce the length of hospital stays.

UCAs are liquid suspensions of tiny gas-filled microbubbles that are injected into a patient’s arm vein during the ultrasound exam. As the UCA flows through the bloodstream, it reflects ultrasound waves in real time, helping physicians more accurately diagnose medical conditions and monitor therapy. According to the Citizen Petition, UCAs present no known risk of kidney or liver damage and are expelled from the body within minutes. In addition, patients do not require sedation during the contrast-enhanced ultrasound (CEUS) exam.

Three UCAs are currently approved for use in the United States -- Definity (Lantheus Medical Imaging), Lumason (Bracco) and Optison (GE Healthcare).

“The risk-benefit ratio for UCA use has dramatically changed since 2007, when the FDA first mandated the black box,” according to cardiologist Mike Main of Saint Luke’s Mid America Heart Institute in Kansas City. Main is a Vice President of ICUS and the principal author of recent studies examining the safety of UCAs.

“Scientific data now consistently show that UCAs are extremely safe, and their benefits have been extended as a result of newly approved applications and use in larger patient populations,” Main added.

ICUS represents cardiologists, radiologists, and other physicians and imaging professionals in approximately 60 countries. The organization’s board recently voted to formally request FDA action on the black box warning.

“The boxed warnings are appropriate only as an indicator of the very highest level risk associated with FDA-approved products,” said Dr. Steven Feinstein, a cardiologist and professor of medicine at Rush University Medical Center in Chicago and ICUS Co-President. “This extreme level of risk is simply not presented by the use of UCAs, and ICUS is deeply concerned that the current boxed warnings unduly deter the use of UCAs when medically indicated -- to the detriment of our patients,” Feinstein added.

UCAs are approved in the United States for cardiac and liver imaging in adults, and were recently also approved for use in children. But throughout Europe, Canada, Asia and Brazil UCAs are safely and routinely used to pinpoint cancers elsewhere in the body, monitor chronic gastro-intestinal diseases, detect vascular disease, as well as diagnose heart disease and other serious medical conditions.

“The United States is actually behind the rest of the world when it comes to using contrast-enhanced ultrasound,” according to Dr. Stephanie Wilson, Co-President of ICUS and Clinical Professor of Radiology at the University of Calgary. She said CEUS is very patient friendly, extremely reliable and easy to use.

The Petition notes that the FDA has steadily responded to the mounting evidence of safety and efficacy by downgrading package insert contraindications three times since 2007 and removing a 30-minute monitoring requirement for patients with pulmonary hypertension or unstable cardiopulmonary conditions. More recently, the FDA approved new indications for use in additional patient populations.

According to the Citizen Petition, “The (published scientific) evidence more clearly supports a warning in the ‘warnings and precautions’ section, as the potential adverse reactions (namely, a serious allergic or anaphylactoid reaction or CARPA reaction) do not occur frequently enough to rise to the boxed warning standard.”

“Now, with even more published research and clinical experience demonstrating the very strong safety profile and efficacy of UCAs, together with expanded UCA indications and patient populations for whom CEUS is clinically appropriate, it is time to remove the ‘black box’ entirely,” according to Main.

ABOUT ICUS:

The International Contrast Ultrasound Society (ICUS) is an international medical society dedicated to advancing the appropriate use of contrast enhanced ultrasound (CEUS) to improve patient care. ICUS members include physicians, scientists, and other ultrasound imaging professionals in approximately 60 countries. For more information about ICUS, please visit .

View source version on businesswire.com:https://www.businesswire.com/news/home/20180917005620/en/

CONTACT: International Contrast Ultrasound Society

Mark W. Weller, 202-276-7421 or 202-626-8363

mweller@polsinelli.com

or

Linda M. Feinstein, 847-624-1844 or 312-876-2563

Linda.Feinstein@Dentons.com

KEYWORD: UNITED STATES NORTH AMERICA ILLINOIS

INDUSTRY KEYWORD: HEALTH CARDIOLOGY HOSPITALS MEDICAL DEVICES ONCOLOGY RADIOLOGY RESEARCH FDA SCIENCE GENERAL HEALTH

SOURCE: International Contrast Ultrasound Society (ICUS)

Copyright Business Wire 2018.

PUB: 09/17/2018 01:30 PM/DISC: 09/17/2018 01:30 PM

http://www.businesswire.com/news/home/20180917005620/en

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