FDA Orders Black Box Warning for Gadolinium-Based Contrast Agents

ROCKVILLE, Md., May 23 -- The FDA today ordered black-box warnings for all gadolinium-based contrast agents for magnetic resonance imaging, detailing an increased risk for nephrogenic systemic fibrosis with kidney-disease patients.

The warning alerts clinicians of possible severe kidney insufficiency in patients at risk for nephrogenic systemic fibrosis, a potentially fatal disease, who receive gadolinium-based agents. The boxed message also warns that the nephrogenic systemic fibrosis risk extends to patients with chronic liver disease including those just before or after liver transplantation.

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