FDA Approves Lumason Microsphere Echo Contrast

October 10, 2014

WASHINGTON, DC — The US Food and Drug Administration has approved a new microbubble contrast agent for echocardiography: Lumason (Bracco Diagnostics) sulfur-hexafluoride lipid microspheres, announced a statement from the agency[1].

Lumason's safety and efficacy had been explored and defined in three trials totaling 191 patients with suspected heart disease but hard-to-interpret standard echocardiograms, the statement said.

The product's labeling must carry a boxed warning of possible cardiopulmonary reactions, as must all similar agents. In 2013, an FDA advisory panel mulled whether such a warning was necessary and concluded there weren't sufficient data to arrive at a clear decision. As reported by heartwire at the time, an unofficial, unscientific show of hands at the joint meeting of the Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee appeared to favor keeping the box.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....