Risks of a Gadolinium-Enhanced MRI: NSF / NFD

Patients undergoing MRI scans currently have two options — a conventional (unenhanced) MRI and an enhanced MRI. The difference between the two procedures is the latter uses a special contrast agent to enhance certain portions of the obtained images. Thus, during an enhanced MRI procedure, a patient is injected with a special substance (called a contrast agent) that makes abnormal tissues appear very bright on MRI scans. This enhancement allows doctors to better identify and assess tumors and other abnormal tissue growths throughout the body.

The FDA has approved five substances for the use during enhanced MRI scans: Magnevist, MultiHance, Omniscan, OptiMark and ProHance. All these contrast agents are based on gadolinium, a chemical element with special magnetic properties. Until recently, the use of these gadolinium-based contrast agents was considered a relatively safe practice. However, recently gadolinium exposure has been linked to the onset of a debilitating disease called nephrogenic systemic fibrosis / nephrogenic fibrosing dermopathy (NSF / NFD).

Symptoms and Treatment of NSF / NFD

NSF / NFD is a rare disease most often afflicting patients with serious kidney problems, such as renal insufficiency. The first symptoms of NSF / NFD usually appear within six months after undergoing a gadolinium-enhanced MRI procedure. For patients with kidney problems, even a single exposure to gadolinium can trigger the onset of NSF / NFD, with each subsequent exposure increasing the risk.

The tell-tale sign of NSF / NFD is hardening of skin. Victims of this disease usually notice that the skin of their arms and legs begins to thicken, taking on a “wooden” or “orange peel” appearance. In addition, patients might experience skin rushes, itching and burning sensations and massive skin swelling. Since NSF / NFD is a progressive condition affecting the whole body, its victims might also develop one or more of the following symptoms:

• Inability to fully extend arms and legs
• Difficulty walking
• Joint pain and/or pain deep in the ribs and hip bones
• High blood pressure
• Raised yellow spots on the whites of the eyes

The diagnosis of NSF / NFD is confirmed through a skin biopsy. Regarding treatment, currently there is no consistent therapy for this disease. In some patients, the progression of NSF / NFD has been slowed by kidney transplants, oral steroids therapy, ultraviolet light treatments and/or physical therapy. However, these treatment modalities can only slow the progression of NSF / NFD but cannot fully cure this devastating disease.

Gadolinium Exposure: FDA Warnings

Since the FDA received the first evidence of a potential link between gadolinium exposure and NSF / NFD, it has conducted research to determine if using gadolinium-based contrast agents should be banned. In 2006 it provided healthcare professionals with an official letter explaining the potentially fatal side effects of gadolinium exposure and urging them not to use gadolinium-enhanced MRI scans on patients with serious kidney problems.

In 2007, the FDA instructed manufacturers of gadolinium-based contrast agents to place a black box warning on their products. This is the strongest possible FDA warning short of a complete product recall. In addition, pharmaceutical companies are now required to include detailed warning information in the packaging of all gadolinium-based products describing the potential side effects of using these drugs.

Legal Rights of NSF / NFD Victims