The FDA May Tighten Rules on Omniscan, a GE MRI Drug

An FDA review says MRI imaging drugs that contain gadolinium may be even riskier for kidney patients than it previously believed

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Editor's Note: Gerth is a reporter with ProPublica, a nonprofit journalism organization in New York.

The U.S. Food & Drug Administration is weighing further regulation of three drugs used to create high-contrast images on MRI scans, based on a new analysis that suggests they carry a higher risk of causing a rare, but potentially fatal disease.

The issue, highlighted in an October story by BusinessWeek and ProPublica, marks a setback for GE Healthcare (GE), which contends that its product is no riskier than competing imaging drugs. FDA reviewers said GE's drug, Omniscan, had a disproportionately high number of reports of the disease compared with its peers.

An FDA advisory panel is scheduled to assess on Dec. 8 whether new restrictions or warnings are in order for the three drugs. The others are Bayer HealthCare's Magnevist, the market leader, and Optimark, made by Mallinckrodt.

All three have been associated with nephrogenic systemic fibrosis, or NSF, which can occur in patients with impaired kidney function. The drugs, which contain the metal gadolinium, are injected during magnetic resonance scans. Although the cause of NSF is uncertain, researchers theorize that an inability to eliminate gadolinium may be a factor. About 8 million vials of gadolinium-based imaging agents are sold each year. So far, the number of NSF cases numbers in the hundreds.

More than 500 lawsuits in U.S. courts

In patients who do contract the disease, however, outcomes can be painful, disfiguring, and deadly. The skin thickens and hardens around joints, gradually limiting movement and crippling or incapacitating some victims. The disease also can affect internal organs and set the stage for a lung embolism or other potentially life-threatening condition. The disease has no known cure, and the FDA said the two-year mortality risk for NSF patients is more than double that of kidney patients without the disease.

More than 500 lawsuits over NSF have been filed in U.S. courts against makers of gadolinium-based MRI drugs. The majority target GE and Omniscan, and the drug has been the one most cited in NSF reports filed with the FDA and European regulators.

Many major hospitals across the country stopped using Omniscan once the link to NSF first appeared. In the last two years, reports of new NSF cases have virtually ceased as warnings by regulators, manufacturers, and doctors took hold.

The new FDA assessment suggests a possible shift in agency policy.

After a link first emerged in early 2006 between NSF and scanning drugs, the FDA treated all the agents—seven are now sold in the U.S.—as a class. That put the agency at odds with European regulators, influential American radiologists, and two of its own medical reviewers, all of whom had flagged Omniscan as a riskier agent.

GE opposes any focus on Omniscan

GE has relied on the FDA's stance to reinforce its scientific and marketing messages about Omniscan's safety. In court and at the FDA, the company has argued against singling out its drug from competing gadolinium-based agents. "There is no definitive evidence establishing that the risk of acquiring NSF is greater for one agent than for the others in the class," the company says in a new filing to the advisory panel.

Although GE has not proposed a labeling change, the company advises against using Omniscan in scans of the sickest kidney patients.

The FDA has asked the panel for comment on its latest risk assessment and on filings submitted by the manufacturers.