Contrast Imaging Agent Gets FDA Approval
January 5th, 2009
The U.S. Food and Drug Administration (FDA) has approved Vasovist® (gadofosveset trisodium), a new injectable contrast imaging agent for use in patients undergoing magnetic resonance angiography (MRA).
A physician may order an MRA for a patient to evaluate or detect vascular system problems, such as a narrowing or blockage of blood vessels.
An MRA is performed with or without contrast using magnetic resonance imaging (MRI) to create highly-detailed images of the inside of the body. The use of contrast generally provides superior results.
Vasovist® is injected directly into a peripheral vein and considered generally safe. The primary safety risks are allergic reactions and N. ephrogenic systemic fibrosis, a rare syndrome involving the thickening of the skin, joints, eyes, and internal organs. The FDA issued a warning about this syndrome in May 2007 and information about it is included in a boxed warning for all drugs containing gadolinium, including Vasovist®.
Vasovist® is manufactured by EPIX Pharmaceuticals Inc, Lexington, Mass.
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