MRI Scan Imaging Agents Linked to Deadly Skin Disease, FDA Says
Chemical agents used to improve the results of MRI scans appear to cause a potentially fatal skin disease, according to newly released Food and Drug Administration documents.
According to a Reuters news report, the use of some of contrasting agents increases the chances of developing nephrogenic systemic fibrosis, a progressive disease that results in thickening and hardening of the skin, particularly in the arms, legs and other extremities. In the worst cases, NSF can be fatal.
The highest risks of NSF are found in people treated with Omniscan (GE Healthcare), Magnevist (Bayer Schering Pharma), and Optimark (Covidien), the FDA said. ProHance and MultiHance, two agents made by Bracco Diagnostics were associated with the lowest risks of the skin disease.
FDA Advisory Panel Set to Meet
A panel of medical experts who advise the FDA on the safety and efficacy of drugs and medical devices is set to consider the apparent link between MRI imaging agents and NSF during a meeting next month, officials said. The panel could recommend new warnings for the use of the chemical agents and the risks of the skin disease.
At this point, staffers in the FDA’s drug safety unit say the NSF risk “does not compel removal of specific (imaging agents) from the U.S. market,” according to the released documents. However, the agency said the labeling on the individual drugs should reflect the varying degrees of NSF risks associated with each product, staffers said.
FDA Warnings of NSF in MRI Imaging Agent Patients
In June 2006, the FDA warned health-care professionals and patients about a possible link between NSF and specific gadolinium-based contrast agents used in MRI scans. The agency said it had received reports of 90 patients with moderate to end-stage kidney disease who developed NSF following an MRI or MRA with a gadolinium-based contrast agent. The FDA said it was continuing to investigate the possible link.
Then, in May 2007, the FDA asked manufacturers of gadolinium-based contrast agents used in MRI scans to include warnings on the product labeling to alert patients with severe kidney insufficiency who receive gadolinium-based agents about the risk for developing NSF.
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