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# Medical Group Petitions for Contrast Agent Warning Removal
- URL: https://www.fdaweb.com/medical-group-petitions-for-contrast-agent-warning-removal/
- Published: 2020-08-31T12:00:00.000Z
- Updated: 2026-09-14T16:27:05.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147550

International Contrast Ultrasound Society (ICUS) has [petitioned FDA](http://www.marketwatch.com/story/fda-urged-to-remove-boxed-warnings-on-ultrasound-contrast-agents-2020-08-31?ref=fdaweb.com) to remove Boxed Warnings from ultrasound contrast agents (UCAs), citing scientific data to demonstrate product safety and life-saving potential. “It is now abundantly clear that UCAs are extremely safe, and that they may save lives and lower overall diagnostic imaging costs,” the group says, adding that UCAs present no known risk of kidney or liver damage, and are expelled from the body within minutes. The group also argues that the current labeling is outdated and may harm patients by unduly deterring the use of UCAs in patients who would benefit from an enhanced ultrasound scan.

UCAs are radiation-free imaging agents comprising biocompatible suspensions of tiny gas-filled microbubbles that are injected intravenously during an ultrasound exam, ICUS says. “They produce high resolution ultrasound images that can dramatically improve the detection of heart disease, stratify risk of heart attack or stroke, and help identify, characterize and stage tumors of the liver, kidney, prostate, breast and other organ systems,” it says.