Gadavist Approved to Enhance Nervous System Imaging
A contrast agent for certain MRIs
TUESDAY, March 15 (HealthDay News) -- 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.Scott Roberts Related Articles
- Lynparza Approved for Advanced Ovarian Cancer
December 19, 2014
- System Approved to Remove Germs From Blood Platelets
December 19, 2014
Learn More About Sharp
Sharp HealthCare is San Diego's health care leader with seven hospitals, two medical groups and a health plan. Learn more about our San Diego hospitals, choose a Sharp-affiliated San Diego doctor or browse our comprehensive medical services.
Copyright © 2011 HealthDay. All rights reserved.