Gadavist Approved to Enhance Nervous System Imaging
TUESDAY, March 15 -- Gadavist (gadobutrol) has been approved by the U.S. Food and Drug Administration as a contrast agent for people having magnetic resonance imaging (MRI) of the central nervous system.
The gadolinium-based agent will help doctors detect lesions that affect the cell barrier between the brain and the blood stream, the FDA said in a news release. Approved for patients 2 years and older, the agent was evaluated in two clinical studies involving 657 patients.
Gadavast and similar agents include a boxed warning about the possibility of nephrogenic systemic fibrosis (NSF) in some people with kidney problems. NSF is a rare condition, characterized by thickening of the skin, that may lead to development of excess fibrous connective tissue in some internal organs. Gadavast, however, is thought to put users at lower risk of NSF, as compared to similar contrast agents, the FDA said.
The most common side effects reported during clinical testing of Gadavast included headache, nausea and so-called "hypersensitivity" reactions, the agency said.
Gadavast is produced by Bayer Pharmaceuticals, based in Wayne, N.J.
The FDA has more about its label warnings for MRI contrast agents.
Posted: March 2011