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Gadolinium

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Charleston, West Virginia

"Black Box" warning now on labeling of MRI/MRA contrast agents containing Gadolinium due to risk of potentially life-threatening disease in kidney patients.

In September 2007, the US Food and Drug Administration (FDA) announced that MRI/MRA contrast agents containing Gadolinium will now carry its strongest type of warning-a "Black Box" warning. This labeling change is due to the risk of such agents potentially causing a debilitating, and possibly fatal, disease in patients with serious pre-existing kidney problems, when the agents are used in MRI and MRA procedures. This "Black Box" warning information was provided by the manufacturers of Gadolinium-based contrast agents to healthcare professionals in a "Dear Healthcare Professional" letter issued September 12, 2007.

The "Black Box" warning was requested by the FDA in May 2007. Contrast agents are substances injected into the body area being imaged in order to enhance the quality of the MRI (magnetic resonance imaging) or MRA (magnetic resonance angiogram). Persons with severe kidney (renal) problems who have had an MRI or MRA in which contrast agents containing Gadolinium have been used are at risk of contracting a potentially life-threatening disease known as NSF (Nephrogenic Systemic Fibrosis), also called NFD (Nephrogenic Fibrosing Dermopathy).

As of September 2007, the FDA had received reports of more than 250 cases of NSF/NFD in patients receiving injections of Gadolinium-based contrast agents. Patients with NSF/NFD develop swelling, thickening and hardening skin, generally in the extremities, but occasionally in the torso/trunk area. It may develop within 2 weeks to 3 months after Gadolinium injection. The resulting skin thickening can inhibit joint flexion/extension, causing painful contractures. It also affects connective tissues of the body, inhibiting the patient's ability to move and can cause broken bones, and can also result in the hardening of internal organs. Muscle weakness is common. In extreme cases, patients may be unable to walk, or fully extend the joints of their arms, hands, legs, and feet. NSF/NFD may manifest itself initially as reddened/darkened skin patches, papules, or plaque, and may in time result in skin resembling an orange peel. Other symptoms can include burning, itching, or severe sharp pains in the affected areas, or even aches in the hips and/or ribs. NSF/NFD skin lesions are usually symmetrical, appearing between the ankles and thighs, or between the wrist and upper arms. Hand and foot swelling with blister-like lesions has also been reported, as have yellow papules or plaques on or near the eyes. The disease is debilitating, and potentially fatal, and has no consistently effective treatment.

The FDA first notified healthcare professionals and the public about the risks involved in using contrast agents to enhance MRI's/MRA's performed on patients with serious liver conditions in June 2006. Additional risk information was provided in December 2006. There have been no reports of NSF/NFD in patients with normal kidney function, or with mild-to-moderate kidney insufficiency.

Gadolinium has been approved by the FDA as a contrast agent for MRI's, and is marketed under various brand names. Five Gadolinium-based contrast agents have been approved for use in the United States

• Magnevist (gadopentetate dimeglumine), manufactured by Bayer Schering Pharma, Berlin, Germany;
• Ominiscan (gadodiamide), manufactured by GE Healthcare, Chalfont St. Giles, U.K.;
• OptiMARK (gadoversetamide), manufactured by Mallinckrodt, Inc., Hazelwood, Missouri;
• MultiHance (gadobenate dimeglumine); and
• Prohance (gadoteridol), both manufactured by Bracco Diagnostics, Inc., Princeton, N.J.

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Don't be intimidated by big pharmaceuticals or medical device companies. Put the law in your hands - contact defective drug attorneys and medical device recall lawyers at Bell & Bands today. Located in Charleston, we represent clients throughout West Virginia, including Huntington, Parkersburg, Bluefield, Williamson, Morgantown, Fairmont, Martinsburg, Beckley and the entire state of West Virginia.

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As your legal representation, Bell & Bands develops and presents evidence linking your injuries to the use of a particular medical product. Given the fact that recalls have already occurred in the case of many of these products, facts already exist in evidence regarding their dangers. In order to counter defense arguments claiming injuries were caused by a pre-existing condition or factors unrelated to their product, our personal injury attorneys consult with medical doctors and medical device experts, submitting evidence and proof in support of your case.

Bell and Bands is presently taking Gadolinium cases, and we will work hard to obtain compensation for your side effects and suffering. Please fill out our contact form and a representative from the law firm Bell and Bands will be in contact with you as soon as possible.

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