Investigations: Gadolinium based contrast agents for MRI/MRA

Gadolinium (also known as gadodiamide) is a contrast agent solution used during magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA). Gadolinium is injected directly into the bloodstream allowing doctors to more easily visualize and differentiate a patient’s internal organs and tissue from blood vessels. It is colorless, resembling clear water, and is non-radioactive. When gadolinium is exposed to the MRI or MRA, it becomes very bright, highlighting the features of the body and any deposits of the gadolinium fluid, which can indicate abnormal tissue growth. Five gadolinium-based contrast agents have been approved for use by the United States Food and Drug Administration (FDA): Magnevist, MultiHance, Omniscan, OptiMARK, and Prohance.

In patients with normally-functioning kidneys, gadolinium is expelled from the body quickly, creating no damage or risk. However, patients with kidney problems, such as a diabetic on dialysis, are not able to completely flush gadolinium from their circulatory system, which can cause serious complications, including nephrogenic systemic fibrosis (NSF), also known as, nephrogenic fibrosing dermopathy (NFD).

NSF/NFD is a debilitating and potentially fatal disease that causes swelling and tightening (fibrosis) of skin, joints, eyes, and internal organs. In NSF/NFD, individuals develop large areas of hardened skin, painful joint contractures, and limited range of movement in the extremities resembling scleroderma or systemic sclerosis. NSF/NFD symptoms can include itching, swelling, hardening, and burning of the skin; dark or red patches appearing on the skin; trouble moving or straightening the arms, legs, hands, or feet; yellow spots on the whites of the eyes; muscle weakness; and pain in the hips or ribs. These symptoms can onset any time between 2 days and 18 months after the initial injection of gadolinium.

There is currently no effective treatment for NSF/NFD, but the progress of the disorder can be halted or reversed by improving kidney function. NSF/NFD treatments that have been tried and continue to be investigated include oral steroids, ultraviolet therapy, high dose intravenous immunosuppressive therapy, and kidney transplantation.

The FDA first notified health care providers and the public about gadolinium-related risks for NSF/NFD in June 2006 after receiving 25 reports of individuals with underlying kidney disease suffering NSF/NFD after being exposed to a gadolinium-based contrast agent prior to undergoing an MRI or MRA. In December 2006, the FDA issued a second safety alert after receiving reports of 90 cases of NSF/NFD in patients with moderate to end-stage kidney failure who developed NSF/NFD following exposure to gadolinium-based contrast agents. In May 2007, the FDA required manufacturers of gadolinium-based contrast agents to include a new “black box” warning and updated warning section on the product labeling for all gadolinium-based contrast agents. A “black box” warning is the highest warning the FDA can place on a prescription drug or medical device before removing the product from the market completely. Most recently, in September 2007, the manufacturers of gadolinium-based contrast agents sent a “Dear Doctor Letter” to healthcare professionals notifying physicians of the updated warnings.

If you or someone you know is a kidney failure patient who has been diagnosed with Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) after receiving an MRI or MRA, please call Lewis Saul & Associates toll-free at (888) 747-5342 or fill out our convenient online contact form and a member of our firm will contact you by the next business day for a free consultation.