Friday, January 28, 2011

FDA panel backs Bayer imaging drug

Animation of an MRI brain scan, starting at th...Image via WikipediaFrom Reuters:

A Food and Drug Administration advisory panel voted 16-0 in favor of the drug, gadobutrol. The FDA usually follows panel recommendations. A final decision is due by March 14.

Gadobutrol is a stronger version of products in a class called gadolinium-based contrast agents, or GBCAs, used with MRI scans. The drugs carry warnings about the risk of nephrogenic systemic fibrosis (NSF), a potentially fatal skin disorder.

GBCAs with higher NSF risk come with a strong warning that they should not be used in patients with kidney disease, which increases the chances of the skin disorder.

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