New imaging injection approved
The US Food and Drug Administration (FDA) on Tuesday approved a new imaging injection from Bayer Pharmaceuticals to improve the visibility of magnetic resonance imaging scans, reports Bloomberg Businessweek.
The agent, called Gadavist, contains the chemical gadolinium, which is designed to help detect blood flow abnormalities in the brain and central nervous system.
The FDA approved Gadavist for adults and children of two years and older.
The approval follows a unanimous recommendation in January from the agency's advisory committee on nervous system drugs, writes Med Page Today.
The panel voted 16-0 that Gadavist is safe and effective enough to be used with diagnostic magnetic resonance imaging to highlight areas with disrupted blood-brain barrier and/or abnormal vascularity in the central nervous system.
According to US News, 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, characterised 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.
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