Gadovist labeling questions

The FDA will also review the MRI contrast agent gadobutrol, marketed as Gadovist by Bayer Schering Pharma AG.


If given the FDA OK, this would be the sixth gadolinium-based contrast agent approved by the agency.

The agency said the contrast-enhancing drug largely seemed to do what it was claimed to do. But the group worried that though the dose to patients is the same as most gadolinium-based contrast agents, 0.1 mmol/kg, it has a much higher molar strength :1.0M, as opposed to 5.0M.

"[T]he difference in molar strength necessitates administration of a gadobutrol volume that is one half that for the other five" gadolinium agents, the FDA noted. "This difference raises the potential for overdosage if health care providers mistakenly assume the six GBCAs all have the same strength."

The agency noted Bayer has offered to create unique labeling to minimize the risk of error.

The agency will also have to decide whether the drug falls under the higher or lower risk labeling for nephrogenic systemic fibrosis (NSF), an extremely rare but potentially fatal condition associated with the use of gadolinium-based contrast agents among patients with kidney problems.

In Europe, Gadovist is approved to enhance imaging of blood vessels, the brain, spine, liver and kidney. Last week, Bayer said it got approval to use the drug in children over seven in most of Europe's main markets, such as Germany.

The drug was first approved for use in 1998, and is currently available in around 50 countries, the company said.


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