Gadolinium/NSF

The Food and Drug Administration (FDA) issued a second Public Health Advisory in December 2006 about a new skin disorder known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermotherapy (NSF/NFD). The disease is debilitating and may cause death.

As of December, the FDA had received reports of 90 patients with moderate to end-stage kidney disease who developed NSF/NFD after having an MRI (Magnetic Resonance Imaging) or MRA (Magnetic Resonance Angiography) scan with a gadolinium-based contrast agent. The FDA has been investigating this link between the gadolinium-based agents and NSF/NFD since June 2006.

NSF/NFD is characterized by areas of tight and rigid skin that makes it difficult to bend joints. It may also result in fibrosis or scarring of body organs resulting in the inability of body organs to work properly and can lead to death.

Other signs of NSF/NFD also include:

• Burning
• Itching
• Swelling
• Hardening and tightening of the skin
• Red or dark patches on the skin
• Yellow spots on the whites of the eyes
• Stiffness in joints and trouble moving or straightening the arms, hands, legs, or feet
• Pain deep in the hip bones or ribs
• Muscle weakness

What is Gadolinium-based Contrast Agent

An MRI scan is performed to take a clear detailed picture of a patient's internal organs and tissue and an MRA is used to take a detailed picture of a patient's blood vessels. During some MRI scans and all MRA scans, a gadolinium-based contrast agent is injected into the patient's vein so blood vessels can be distinguished from other nearby tissues.

Five gadolinium-based contrast agents are approved by the FDA for use during an MRI. The trade names for these products are:

• Omniscan
• OptiMARK
• Magnevist
• ProHance
• MultiHance

None of these agents are approved by the FDA for MRA. The dose of gadolinium-based contrast agent given to patients undergoing an MRA is often higher (up to three times) than the approved dose for MRI.

In the 90 reports received by the FDA, some of the patients who developed NSF/NFD had been given a high dose of the contrast agent while others had received the recommended amount. In these patients, the NSF/NFD began from 2 days to 18 months after exposure to the contrast agent.

Note - Do not change medications without first consulting your doctor.

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