Pharmaceutical Litigation
MRI Injury Nephrogenic Systemic Fibrosis from gadolinium-based contrast agents
Manufacturers: Bayer Schering Pharma, Berlin, Germany, manufactures Magnevist; GE Healthcare, Chalfont St. Giles, U.K., is the maker of Omniscan; OptiMARK is manufactured by Mallinckrodt, Inc., Hazelwood, Mo.; and ProHance and Multihance are made by Bracco Diagnostics Inc., Princeton, N.J.
Uses: Gadolinium-based contrast agents are used to enhance the quality of magnetic resonance imaging (MRI). The contrast agents improve the visibility of internal structures when patients undergo an MRI.
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Five gadolinium-based contrast agents have been approved for use in the United States: Magnevist (gadopentetate dimeglumine), Ominiscan (gadodiamide); OptiMARK (gadoversetamide); MultiHance;(gadobenate dimeglumine); and Prohance (gadoteridol).
In May 2007, the Food and Drug Administration asked manufacturers to include a new boxed warning on the product labeling of all gadolinium-based contrast agents. The FDA said patients with severe kidney problems that received products with gadolinium during MRI procedures were at risk for developing a debilitating -- and potentially fatal -- disease known as nephrogenic systemic fibrosis (NSF).
Patients with NSF usually have a swelling or tightening of the skin that develops over a period of days to several weeks. In many cases, the skin thickening inhibits the flexing of joints. In severe cases, patients may be unable to walk or fully extend the joints in their arms, hands, legs and feet. Many people with the condition also complain of muscle weakness.
“Patients with NSF develop thickening of the skin and connective
tissues that inhibits their ability to move and may result in broken bones,”
according to an FDA news release. “Other organs are at risk of thickening as
well. The cause of NSF is not known and there is no consistently effective
treatment of this condition.”
The FDA said patients should be screened for
kidney problems prior to receiving one of these imaging
agents.
If you or a loved one has developed the symptoms of Nephrogenic
Systemic Fibrosis after an MRI procedure, call Peterson & Associates today or
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Side Effects
- Swelling and tightening of the skin
- Skin redness and thickening
- Loss of motion in joints of arms, hands, legs and feet
- Muscle weakness
- Bone pain
- Skin lesions
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