Diagnostic Imaging: FDA urged to nix black box label for ultrasound contrast agents

Citing significant clinical evidence of safety, a multi-institutional, grassroots group has asked the U.S. Food and Drug Administration (FDA) to remove the black box warning from ultrasound contrast agents (UCAs), calling the label “outdated.”

The FDA removes a black box warning when clinical evidence reveals the risks and safety concerns of a product are less severe than originally believed. 

“It is now abundantly clear that UCAs are extremely safe, and that they may save lives and lower overall diagnostic imaging costs,” said Michael Main, M.D., a cardiologist, co-executive medical director of Saint Luke’s Mid America Heart Institute.

Read the full article: FDA urged to nix black box label for ultrasound contrast agents