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# Petition: Remove Boxed Warning from Contrast Agents
- URL: https://www.fdaweb.com/petition-remove-boxed-warning-from-contrast-agents/
- Published: 2019-03-05T12:00:00.000Z
- Updated: 2026-09-15T01:10:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143526

National and international ultrasound societies have petitioned FDA to remove a “black box” warning from ultrasound contrast agent (UCA) labels. The petition, filed by the [International Contrast Ultrasound Society](http://icus-society.org/wp-content/uploads/2019/03/ICUS-Press-Release-3-5-19-Support-for-ICUS-Citizen-Petition.pdf?ref=fdaweb.com), cites an extensive body of favorable safety data that were not available in 2007 when the boxed warnings were first mandated by the agency. “It is clear to all who work in the field on a daily basis that the black box harms patient care by misrepresenting risk and inappropriately deterring the use of UCAs when they are medically indicated,” ICUS co-president Steven Feinstein says.

UCAs are injected into a patient’s arm vein during a diagnostic ultrasound scan to help diagnose heart disease, pinpoint and characterize cancers, monitor chronic gastro-intestinal diseases, detect vascular disease, evaluate other serious medical conditions and monitor therapy, the petition says. “By improving the reliability of real-time ultrasound scans, UCAs often reduce the need for unnecessary downstream tests and related costs, speed up the time to diagnosis and access to appropriate therapy, reduce the length of hospital stays, and improve patient care, outcomes and experiences,” it says.

Three UCAs are currently approved for use in the U.S. — Definity (Lantheus Medical Imaging), Lumason (Bracco) and Optison (GE Healthcare).