FDA Approves GE Imaging Dye, Loses $5M Jury Decision on Old Dye

GE Healthcare just announced a win and a loss over its AdreView and Omniscan imaging agents.

GE achieved a U.S. Food and Drug Administration (FDA) win for its AdreView, a new nuclear imaging agent, said MassDevice. GE also lost a $5 million jury decision that found in favor of a patient whose devastating disease was blamed on contact with the older dye, Omniscan.

Omniscan is gadolinium contrast dye that is used to enhance images in MRI procedures. Gadolinium contrast dyes are sold under the names Ablavar, Eovist, Magnevist, Multihance, Omniscan, Optimark, and Prohance.

Gadolinium contrast dyes are believed to be associated with nephrogenic systemic fibrosis (NSF), an often-fatal disease marked by the formation of excess fibrous connective tissue in the skin, joints, eyes, and internal organs. Evidence suggests that NSF is most likely to occur in people with severe kidney disease who have been exposed to a gadolinium contrast dyes.

In 2007, the FDA mandated that all gadolinium agents sold in the United States carry a black box warning, the agency’s strongest safety notice, regarding the risk of NSF. The agency later ordered the warning be strengthened and, in 2010, use of Omniscan and other gadolinium contrast dyes were banned in patients with severe kidney disease.

The agency stated that Omniscan, Magnevist, and Optimark, all gadolinium-based contrast agents, were linked with increased risks for NSF. The FDA also said that enhanced screening to identify NSF risk was needed and advised physicians to report NSF cases, said ProPublica.

In this recent case, an Ohio jury ruled in favor of a patient who claimed GE Healthcare neglected to warn physicians and patients about possible risks associated with use of the Omniscan MRI imaging agent, especially in patients with kidney disease, said MassDevice.

GE said it would appeal the decision on “several grounds,” it told ProPublica. The jury awarded $4.5 million to the plaintiff and an additional $500,000 to his wife after rejecting GE’s claims that it promptly and correctly warned patients and physicians about Omniscan’s dangers, said MassDevice.

The plaintiff also claimed that GE ordered one of its scientists to burn potentially damaging Omniscan dye research. It seems that some MRI contrast agents, such as Omniscan, contain gadolinium, a chemically coated and toxic metal. Healthy patients are able to expel gadolinium through their kidneys with no significant harm; however, this may take longer in patients with kidney disease, which could increase risks that the toxin might un-bond from its protective coating, explained MassDevice.

Meanwhile, the FDA approved GE’s new AdreView cardiac imaging agent, a first-of-its-kind molecular imaging dye that is meant to enable physicians to evaluate cardiac nerve function, explained MassDevice.