FDA eases black box restrictions for ultrasound contrast media

May 14, 2008

The FDA has eased off on stringent black box warnings that greatly restricted use in the U.S. of microbubble ultrasound media during echocardiography.

The FDA has eased off on stringent black box warnings that greatly restricted use in the U.S. of microbubble ultrasound media during echocardiography.

An online edition of the Wall Street Journal reported May 13 that the FDA had lowered a ban against the use of Definity, formerly sold by Bristol-Myers Squibb, and Optison, a microbubble agent sold by GE Healthcare, for echocardiography performed on acutely ill patients.

The agents may again be used to enhance echo procedures applied to patients with unstable congestive heart failure or acute coronary syndrome.

The FDA ordered black box warnings for Definity and Optison in October 2007 following reports of 11 deaths allegedly associated with the two agents. The related ban nearly entirely halted the use of Definity, which was mainly administered to acutely ill patients.

Bristol-Myers-Squibb Medical Imaging in North Billerica, MA, adopted the name Lantheus Medical Imaging in March. GE was not actively marketing Optison when the black box restrictions were first ordered.

Some FDA-mandated labeling restrictions remain, according to a May 13 news release from Lantheus. Definity is now contraindicated for patients with known or suspected right-to-left, bidirectional, or transient right-to-left cardiac shunts and hypersensitivity to perfluten, an ingredient of the microspherical agents. Intra-arterial injection is still banned.

The agency has approved similar label updates for all perfluten-containing microsphere contrast agents, according to the company. Definity has been administered to more than two million patients worldwide, mainly those with a previous suboptimal echocardiogram. Microbubble ultrasound contrast media is not approved for noncardiac applications in the U.S.

The FDA announcement followed publication of a retrospective study in the Journal of the American College of Cardiology (2007; 1704-1706). The review, involving 18,671 consecutive patients at St. Luke's Mid-America Health Institute in Kansas City, MO, found no increased mortality risk for patients who received Definity-enhanced echocardiography compared with patients who were imaged without the agent.

For more information from the Diagnostic Imaging archives:

FDA warning flummoxes ultrasound contrast trial

Barnes-Jewish drops echo contrast before FDA alert

Black box warning planning for ultrasound microbubble contrast