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

September 1, 2020

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Drug Administration (FDA) to remove the black box warning from ultrasound contrast agents (UCAs), calling the label “outdated.”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

Related Content

Des Moines Register logo
Des Moines Register: Iowa-raised cardiologist: No substitute for hospital when experiencing symptoms associated with heart attacks or stroke
Dr. Michael Main is a native Iowan. He spoke to the Des Monies Register about how Saint Luke's changed its approach to telehealth in a matter of days amid COVID-19.
NBC Nightly News: Doctors turn to telemedicine for routine visits as hospitals face coronavirus crisis
Virtual visits are becoming much more common as patients stay home amid the coronavirus pandemic. NBC Nightly News talked to doctors at Saint Luke's Mid America Heart Institute about how they are utilizing the technology to deliver the best patient care.
Stock photo illustration of ambulance
Kansas City Star: 'Heart attacks at home'? Amid COVID-19, people avoid the ER, and doctors are worried
The coronavirus pandemic is causing another health emergency—people are not seeking treatment for heart attacks, strokes, and other serious illnesses. The Kansas City Star talked to Dr. Michael Main about why seeking care quickly is crucial.