by
Brendon Nafziger, DOTmed News Associate Editor | January 21, 2011
A U.S. Food and Drug Administration advisory panel Friday gave a green light to Bayer Schering Pharma AG's magnetic resonance imaging contrast agent Gadovist, and voted against slapping on a high-risk label for potential skin reactions.
The 16-member panel voted unanimously to approve the gadolinium-based contrast agent (GBCA), also known as gadobutrol, for detecting blood flow problems in the brain and spine, Reuters reports. In Europe, where the drug has been approved since 1998, the drug is also indicated for kidney and liver imaging.
The group voted 15-1 to give the drug labeling for the lowest risk for nephrogenic systemic fibrosis, a rare but potentially fatal skin disorder linked to GBCA use in patients with kidney problems. Ten patients worldwide have suffered NSF after having Gadovist, Bayer said, though eight were also given another GBCA.
The agency had previously worried that the drug presents an overdose risk. It has twice the strength of the five GBCAs previously approved for MRI, although it is given at the same dose. Bayer said it would emphasize the drug's higher strength in its labeling, Reuters reported.
About 5 million patients have used Gadovist worldwide.
The FDA's final decision is expected March 14, according to Reuters.
