The FDA approved the microbubble contrast agent Lumason to be used for contrast-enhanced echocardiographic imaging.
“Sometimes echocardiograms in certain patients are difficult for physicians to see and interpret,” Libero Marzella, MD, PhD, director of the Division of Medical Imaging Products in the FDA’s Center for Drug Evaluation and Research, said in a release. “Today’s approval provides doctors with another option when performing contrast-enhanced ultrasound.”
As with other microbubble contrast agents, Lumason will carry a boxed warning about the risk of serious cardiopulmonary reactions, including fatal cardiac or respiratory arrest. The risk of these reactions may be increased among patients with certain heart conditions, with most serious reactions occurring within 30 minutes administration.
Lumason is marketed by Bracco Diagnostics.