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?
Stay at the forefront of radiology with the Diagnostic Imaging newsletter, delivering the latest news, clinical insights, and imaging advancements for today’s radiologists.
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.
FDA Clears Point-Of-Care Ultrasound Platform and AI Software for Neuraxial Procedures
July 17th 2025The dual FDA clearances for the Accuro 3S point-of-care ultrasound device and the SpineNav-AI machine learning-based software may enhance precision and safety with ultrasound-guided neuraxial procedures.
FDA Expands Approval of MRI-Guided Ultrasound Treatment for Patients with Parkinson’s Disease
July 9th 2025For patients with advanced Parkinson’s disease, the expanded FDA approval of the Exablate Neuro platform allows for the use of MRI-guided focused ultrasound in performing staged bilateral pallidothalamic tractotomy.