Black box warning planned for ultrasound microbubble contrast

October 8, 2007

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?