Omniscan, Magnevist and OptiMARK Associated with Most NSF CasesJun 24, 2010 | Parker Waichman LLP
GE Healthcare, Magnevist by Bayer Healthcare Pharmaceuticals and Covidien’s OptiMARK
Omniscan by GE Healthcare, Magnevist by Bayer Healthcare Pharmaceuticals and Covidien’s OptiMARK are linked to the highest number of nephrogenic systemic fibrosis (NSF) cases, according the American College of Radiology. The group has advised radiologists to avoid using these three gadolinium contrast agents when administering MRIs to patients with chronic or acute kidney disease.
According to the American College of Radiology advisory, as of December 2009, NSF has been documented in 382 patients who received Omniscan; in 195 patients who received Magnevist; and in 35 patients who received OptiMARK.
In addition to recommending that these agents not be used in people with kidney disease, the group also suggests doctors should obtain renal function tests on their patients at least six weeks before performing an MRI that requires contrast injection.
NSF leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. There are no effective treatments for NSF, and the disease can progress to the point of causing severe stiffness in joints, and it can lead to death.
Since 2007, gadolinium agents sold in the U.S. have carried the same black box warning
While not much is known about the disease, a growing mountain of evidence indicates that NSF is most likely to occur in people with severe kidney disease who have been exposed to a gadolinium contrast dyes. Since 2007, all gadolinium agents sold in the U.S. have carried the same black box warning – the Food & Drug Administration’s (FDA) strongest safety notice – regarding the risk of NSF.
GE Healthcare and the other makers of gadolinium agents are named in approximately 500 lawsuits filed by NSF patients, most of which have been consolidated in the U.S. District Court for the Northern District of Ohio as part of a multidistrict litigation (MDL) before Judge Dan Polster. The first trial in the multidistrict litigation, involving Omniscan, had been scheduled to start later in May, but that case has settled. The next Omniscan trial is slated for later this year.
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