Florida Gadolinium MRI Contrast Attorneys

Background Information and Data

First identified in 1997, NSF has been reported only in patients with acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2) or patients with renal dysfunction due to the hepato-renal syndrome or in the perioperative liver transplantation period. Patients with this condition develop fibrosis of the skin and connective tissues throughout their body. The skin thickening may inhibit flexion and extension of joints resulting in contractures. In addition, patients may develop widespread fibrosis of other organs. A skin biopsy is necessary to confirm the diagnosis. The condition may be debilitating or cause death. Its cause is unknown and there is no consistently successful treatment.

Five GBCAs (Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance) are approved in the U.S. for magnetic resonance imaging (MRI). The GBCAs are sometimes used for MRA (magnetic resonance angiography) although none are FDA-approved for MRA. The administered dose of the contrast with magnetic resonance angiography (MRA) may be higher (up to three times) than the approved dose for MRI. NSF has been reported following administration of all five FDA approved gadolinium-based contrast agents (Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance). However, some adverse event reports of NSF do not include complete information on patients’ GBCA exposure history. Also, reports indicate that some patients received more than one GBCA prior to a NSF diagnosis. The lack of complete information of GBCA exposure, exposure to multiple GBCAs, along with similarities among all these contrast agents, make it impossible at present to definitively determine whether the extent of risks for developing NSF a re the same for all the GBCAs.

In June 2006, FDA first notified healthcare professionals and the public about the risk of NSF following exposure to GBCAs after receiving reports of 25 patients with NSF from the Danish Health Authority. FDA issued additional information to healthcare professionals and the public in December 2006.

FDA review of spontaneously submitted post-marketing reports, sponsor-supplied information and the published literature identifies the following:

• FDA has received reports of patients who developed NSF after exposure to Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance, unspecified GBCA, and multiple GBCAs (following multiple GBCA enhanced MRI scans).
• Among the reports that included renal status information, all patients had acute or chronic severe renal insufficiency, renal dysfunction due to the hepato-renal syndrome or renal dysfunction in the perioperative liver transplantation period. The vast majority of patients were receiving hemodialysis.
• To date, there has not been a report of NSF in a patient with normal renal function or mild to moderate renal insufficiency following GBCA exposure.
• The reported time between receiving a GBCA and subsequent diagnosis of NSF diagnosis is highly variable. Reported times range between days to many months.
• FDA has received reports of patients who died from complications related to NSF.

FDA has requested the manufacturers of the GBCAs to revise the product labels as soon as possible to include a new boxed warning and new Warnings section that describes the risk of NSF.

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