New analysis suggests that 3 MRI contrast agents may be risker than initially thought, leading the FDA to consider further regulation of the drugs. The drugs are linked to a rare, but potentialy fatal disease called nephrogenic systemic fibrosis (NSF). The drugs being examined are Bayer HealthCare’s Magnivest, Mallinckrodt’s Optimark and GE Healthcare’s Omniscan. According to FDA reviewers, Omniscan had a disproportionately high number of NSF reports, compared to its peers. Magnevist, Optimark, and Omniscan are contrast agents, containing the metal gadolinium, which are injected during magnetic resonance scans. Contrast agents are linked to NSF in patients with impaired kidney function. According to researchers, one possible cause is an inability to eliminate gadolinium from the body.
NSF causes a thickening and hardening of the skin around the joints, leading to limited movement and possible incapacitation. Also, internal organs may be affected, potentially resulting in a lung embolism or other life-threatening condition. There is no known cure for NSF. In the U.S., more than 500 NSF cases have been filed, with a majority of those cases involving GE and Omniscan. Further, Omniscan is the contrast agent most cited in reports of NSF filed with the FDA and European regulators. In an FDA review, Omniscan was rated as the least chemically stabale of the contrast agents.
If you or a loved one has had an imaging study with a gadolinium contrast agent, and developed NSF, contact Sheller, P.C., to discuss your potential legal claims. The Sheller firm has a long history of successfully representing people injured by pharmaceutical products and medical devices. Sheller is currently accepting cases of patients who have developed NSF.
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