-- Scott Roberts
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
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,
The FDA has more about its label warnings for
MRI contrast agents.
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