Petition Urges Removal of Black Box Warnings From Ultrasound Contrast Agents
The U.S. Food and Drug Administration (FDA) has received a citizen petition from the International Contrast Ultrasound Society (ICUS), requesting that the agency remove black box warnings on ultrasound contrast agents. In the petition, ICUS notes that a significant body of new research demonstrates a favorable cost-benefit ratio for contrast-enhanced ultrasound. This research, ICUS notes in the document, was not available when the boxed warnings were mandated by the FDA, and the warnings deter use of a safe, inexpensive radiation-free diagnostic imaging tool with potential lifesaving benefits for patients. Moreover, ICUS alleges, recent studies bring to light no increased safety concerns for ultrasound contrast, even among the sickest patients. As such, the society cites in the petition six new safety studies undertaken by product sponsors at the request of the FDA, as well as numerous other independent studies recently published in peer-reviewed journals. ICUS decided to formally request FDA action on the black box warning following a vote taken at its annual conference and board meeting in September.