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Gadolinium Labeling Change – Risk of Nephrogenic Systemic Fibrosis

By September 13, 2010July 16th, 2019Dangerous Drugs, Drug Safety

The FDA is requiring changes in label 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.
The gadolinium constrast agents are sold under the brand names: (1) Ablavar (gadofosveset trisodium), (2) Eovist (gadoxetate disodium), (3) Magnevist (gadopentetate dimeglumine), (4) Multihance (gadobenate dimeglumine), (5) Omniscan (gadodiamide), (6) Optimark (gadoversetamide injection), and (7) Prohance (gadoteridol).
BACKGROUND: GBCAs are intravenous drugs used in diagnostic imaging procedures to enhance the quality of magnetic resonance imaging or magnetic resonance angiography.
RECOMMENDATION: Healthcare professionals should screen patients prior to administration of a GBCA to identify those with acute kidney injury or chronic, severe, kidney disease.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse