September 1, 2020 — Health Imaging

By Matt O’Connor

A nonprofit medical society on Monday urged the U.S. Food and Drug Administration to eliminate “black box” warnings on ultrasound contrast agent labels.

The International Contrast Ultrasound Society made that appeal in a Citizens Petition submitted to the FDA. The Chicago-based organization—which represents cardiologists, radiologists and other imaging experts—pointed to clinical evidence supporting the safety and value of such contrasts.

“It is now abundantly clear that UCAs are extremely safe, and that they may save lives and lower overall diagnostic imaging costs,” Michael Main, MD, senior author of safety studies that were cited in the document, said in a statement.

Black box warnings were first mandated by the FDA in 2007, following a number of deaths that were believed to be linked to ultrasound contrast administration. ICUS has filed similar petitions in the past asking for the administration to remove UCA warnings, including in 2018 and 2019.

In its most recent filing, ICUS said ultrasound contrasts present “no known risk” of kidney or liver damage and noted such agents are passed through the body within minutes. Patients undergoing contrast-enhanced ultrasound exams also do not require sedation, the petition writers added.

The self-labeled grassroots society also noted that there are currently three UCAs approved for use in the U.S. Those include: Definity from Lantheus Medical Imaging, Lumason by Bracco, and Optison from GE Healthcare.

ICUS implored the FDA to heed its request and eliminate the “outdated” warning labels.

“Removing this ‘black box’ will help patients across America access safer, more reliable and more cost-effective diagnostic imaging, while speeding up the introduction of appropriate therapy and saving lives,” the petition reads. “The public interest—as well as the FDA’s own standards—demand nothing less.”