A group representing users of ultrasound contrast agents on August 31 asked the U.S. Food and Drug Administration (FDA) to pull its longstanding "black box" warning on the label of contrast agents.
The International Contrast Ultrasound Society (ICUS) filed a citizens petition with the FDA asking for the removal of the warning. The group claims that recently published clinical studies indicate that the warning is outdated and that ultrasound contrast is extremely safe.
The FDA in 2007 required ultrasound contrast developers to put the warnings on their product labeling after receiving reports of 11 deaths that occurred between 2001 and 2007. At the time, the deaths were believed to have been related to ultrasound contrast administration.
But since then, a number of research studies have been published highlighting the good safety profile of ultrasound contrast. This has prompted contrast users to petition the FDA multiple times to remove the warning.
ICUS notes that there are three ultrasound contrast agents sold in the U.S.: Definity from Lantheus Medical Imaging, Lumason from Bracco Diagnostics, and Optison from GE Healthcare. The petition notes that ultrasound with contrast can reduce the need for downstream medical tests and that the current black box warning could deter the use of contrast with ultrasound and jeopardize patient care.
