FDA Advisory on MRI Contrasting Agents

Lee Coleman

Contributor

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The FDA issued a Public Health Advisory on gadolinium based contrast agents. Information has been received about a new disease, known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD). This may occur in patients with moderate to end-stage kidney disease after they have had a MRI or MRA scan with the gadolinium based contrast agent. There have been 90 reports of patients who have developed NSF/NFD after they have had one of these scans. This disease is diblitating and may cause death.

"First recognized as a disease in 1997, NSF/NFD causes discoloration and thickening or tightening of the skin, resulting in pain, muscle weakness and difficulty bending joints. In many cases, NSF/NFD results in scarring of internal organs that inhibit their ability to function properly, which can be fatal.

More than 215 cases of NSF/NFD have been documented in the last decade, but despite ongoing research, the cause of the disease is unknown. Now, results of a pilot study suggest that gadolinium-containing contrasting agents used for Magnetic Resonance Angiography (MRA) in patients with kidney failure may be the culprit."