The commercial prospects of Definity and Optison, the only two ultrasound contrast media approved for clinical use in the U.S., may be damaged if the FDA moves ahead with plans to require black box warnings for the two echocardiography agents.
The commercial prospects of Definity and Optison, the only two ultrasound contrast media approved for clinical use in the U.S., may be damaged if the FDA moves ahead with plans to require black box warnings for the two echocardiography agents.
The Wall Street Journal reported Monday (Oct. 8) that the FDA is contemplating black box notices warning physicians not to use Definity or Optison for patients with unstable angina, acute heart attack, or unstable cardiopulmonary disease. The list covers most of the patients in the U.S. for whom the ultrasound-enhancing agents are likely to be prescribed. FDA-approved indications for Definity and Optison are limited to the heart.
Definity and Optison are approved for numerous body applications in countries outside the U.S.
The black box warnings will be issued in response to FDA investigations of patient deaths and serious cardiovascular reactions to the microbubble contrast agents, according to the Wall Street Journal. The label will also reportedly instruct physicians to monitor patients' hearts with electrocardiograph for 30 minutes after completing the contrast-enhanced ultrasound exams.
A GE Healthcare spokesperson said the firm and FDA are discussing the label change and implementation strategy for Optison. More than one million doses of Optison have been administered with very few adverse reactions, he said.
For more information, refer to the following stories from the Diagnostic Imaging archives:
Journal Review: AIUM renews crusade to have contrast agents approved for use beyond the heart
Multislice CT and microbubble sonography target inflammation in the small bowel
Ultrasound's future in play: will radiologists remain in the picture?
What New Research Reveals About Novice Use of AI-Guided Cardiac Ultrasound
April 4th 2025In a study recently presented at the American College of Cardiology (ACC) conference, researchers found that novice use of AI-guided cardiac ultrasound after an AI-enabled electrocardiogram increased the positive predictive value for reduced left ventricular ejection fraction (LVEF) or aortic valve stenosis by 33 percent.
The Reading Room: Racial and Ethnic Minorities, Cancer Screenings, and COVID-19
November 3rd 2020In this podcast episode, Dr. Shalom Kalnicki, from Montefiore and Albert Einstein College of Medicine, discusses the disparities minority patients face with cancer screenings and what can be done to increase access during the pandemic.
New AI-Enabled Portable Ultrasound May Facilitate 50 Percent Reduction in Cardiac Imaging Scan Time
March 28th 2025Artificial intelligence (AI)-powered measurement capabilities provide key features with the Compact Ultrasound 5500CV device, which was unveiled at the American College of Cardiology (ACC) conference.