(EMAILWIRE.COM, October 27, 2008 ) New York, NY - Gadolinium is a chemical element that is often used in MRI (Magnetic Resonance Imaging), MRA (Magnetic Resonance Angiogram), X-Ray, and other imaging technology as a contrast agent. Contrast agents are injected into the body of a patient being imaged in order to enhance the quality of the image. The safety of Gadolinium is now being questioned. In 2007, the Food and Drug Administration (FDA) issued its strongest warning (the "Black Box Warning") for MRI/MRA contrast agents that contain Gadolinium because it has been linked to a potentially fatal disease in patients with existing kidney conditions. MRI or MRA patients with severe kidney (renal) problems who are injected with a Gadolinium containing contrast agent are at risk of contracting a potentially life-threatening disease known as Nephrogenic Systemic Fibrosis (NSF), also called Nephrogenic Fibrosing Dermopathy (NFD). There is no consistently effective treatment for this disease.

Gadolinium has been approved by the FDA as a contrast agent for MRI's, and is marketed under the following brand names in the United States:

• Magnevist (gadopentetate dimeglumine) manufactured by Bayer Schering Pharma
• Ominiscan (gadodiamide) manufactured by GE Healthcare
• OptiMARK (gadoversetamide) manufactured by Mallinckrodt, Inc.
• MultiHance (gadobenate dimeglumine) manufactured by Bracco Diagnostics, Inc.
• Prohance (gadoteridol) manufactured by Bracco Diagnostics, Inc.

It is unknown if the risk for developing NSF is the same for all agents. Patients should be screened for kidney problems prior to undergoing MRI with any one of these imaging agents.

Symptoms of NSF/NFD include swelling, thickening and hardening skin in the extremities and occasionally in the torso/trunk area. Symptoms usually appear within 2 to 12 weeks following the Gadolinium injection. Skin thickening due to NSF or NFD often inhibits joint flexion/extension, and causes painful contractures. Other effects of this illness include muscle weakness, hardening of internal organs, reddened or darkened skin patches, and burning, itching, or severe sharp pains in the affected areas.

If you or a family member have undergone MRI / MRA screening with contrast in the recent past and are experiencing any of these symptoms, you should contact your healthcare provider immediately.

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