The International Contrast Ultrasound Society (ICUS) submitted a citizen petition to the FDA asking the agency to eliminate boxed warnings from ultrasound contrast agents (UCAs) because data and clinical experience show they are unnecessary.
In a Sept. 17 release, the ICUS said UCAs improve clarity in ultrasounds, often reducing the need for more expensive and potentially harmful imaging down the road.
"The risk-benefit ratio for UCA use has dramatically changed since 2007, when the FDA first mandated the black box," Mike Main, MD, vice president of ICUS and a cardiologist at Saint Luke’s Mid America Heart Institute in Kansas City, Missouri, said in the release. “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.”
ICUS—representing cardiologists, radiologists and imaging professionals in 60 countries—argued the warnings are needed only in the riskiest FDA-approved products. UCAs do not present such a danger, meaning the warnings could deter their use and negatively impact patient outcomes.
“The (published scientific) evidence more clearly supports a warning in the ‘warnings and precautions’ section, as the potential adverse reactions (namely, a serious allergic or anaphylactoid reaction or CARPA reaction) do not occur frequently enough to rise to the boxed warning standard,” ICUS’s citizen petition read.
Nicholas joined TriMed in 2016 as the managing editor of the Chicago office. After receiving his master’s from Roosevelt University, he worked in various writing/editing roles for magazines ranging in topic from billiards to metallurgy. Currently on Chicago’s north side, Nicholas keeps busy by running, reading and talking to his two cats.