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# Group Seeks Removal of Black Box on Contrast Agents
- URL: https://www.fdaweb.com/group-seeks-removal-of-black-box-on-contrast-agents/
- Published: 2018-09-18T12:00:00.000Z
- Updated: 2026-09-15T00:32:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142380

International Contrast Ultrasound Society (ICUS) has [petitioned FDA](https://www.marketwatch.com/press-release/medical-society-files-fda-citizen-petition-seeking-removal-of-boxed-warnings-on-ultrasound-contrast-agents-2018-09-17?ref=fdaweb.com) urging it to remove boxed warnings from ultrasound contrast agents (UCAs) based on current “highly favorable safety data and clinical experience.” The group’s petition cited studies showing that the contrast agents are safe, improve patient care, reduce overall health care costs, speed up the time to diagnosis and reduce the length of hospital stays. According to the petition, UCAs present no known risk of kidney or liver damage and are expelled from the body within minutes. Three UCAs are currently approved for use in the U.S. — Definity (Lantheus Medical Imaging), Lumason (Bracco) and Optison (GE Healthcare).

  
“The risk-benefit ratio for UCA use has dramatically changed since 2007, when the FDA first mandated the black box,” according to cardiologist and ICUS vice president **Mike Main**. “Scientific data now consistently show that UCAs are extremely safe, and their benefits have been extended as a result of newly approved applications and use in larger patient populations,” Main added.