FDA Alert: New Warnings for Using Gadolinium-based Contrast Agents in Patients with Kidney Dysfunction
Thursday, September 9th, 2010
The FDA is requiring changes in the professional labeling for gadolinium-based contrast agents (GBCAs) to minimize the risk of nephrogenic systemic fibrosis (NSF), a rare, but serious, condition associated with the use of GBCAs in certain patients with kidney dysfunction.
NSF has not been reported in patients with normal kidney function. Patients at greatest risk for developing NSF after receiving GBCAs are those with impaired elimination of the drug, including patients with acute kidney injury or chronic, severe kidney disease. Some toxicity symptoms that may occur as side effects are: skin lesions, orange color to skin, and severe muscle weakness.
GBCAs are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging (MRI) or magnetic resonance angiography.
The FDA recommends health care professionals should screen patients prior to administration of a GBCA to identify those with acute kidney injury or chronic, severe, kidney disease.
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