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Ever since the issue of MRI health risks began circulating, Gadolinium kidney failure has been debated—especially with its link to nephrogenic systemic fibrosis (NSF) and increased risk for MRI and kidney failure when used in association with MRI for persons with compromised kidneys.
However, a new study casts a certain amount of doubt. The study: High-Dose Gadodiamide for Catheter Angiography and CT in Patients With Varying Degrees of Renal Insufficiency: Prevalence of Subsequent Nephrogenic Systemic Fibrosis and Decline in Renal Function, was recently undertaken at the Mayo Clinic in Jacksonville, Florida.
The results of the study were published in the American Journal of Roentgenology.
“The purpose of our study was to evaluate the prevalence of nephrogenic systemic fibrosis and nephrotoxicity among patients with differing degrees of renal dysfunction who are exposed to high doses of gadodiamide,” said Mellena D. Bridges, MD, lead author of the study.
A search of medical records identified patients who received high-dose IV gadodiamide for catheter angiography or CT between January 2002 and December 2005. The cohort was limited to patients who had received a dose of at least 40 mL of gadodiamide during a single imaging session, who underwent at least one year of clinical follow-up, and who had moderate to end-stage renal disease (estimated glomerular filtration rate [GFR] < 60 mL/min/1.73 m2) established within the previous 48 hours. Any observation suggestive of NSF was recorded, as were all estimated GFR values obtained during the two weeks prior and the five days following gadodiamide administration.
“Our patients had been given high doses—from two, to ten times the usual MRI dose. These high doses were used because the patients were undergoing interventional procedures and the procedures were done before there were any reports linking gadolinium to NSF,” continued Dr. Bridges. “Fortunately one of these patients, a 58-year-old diabetic man with end-stage kidney disease and significant blood vessel blockages, developed NSF.”
The conclusion? “Gadolinium seems to be necessary to trigger NSF, but it doesn’t seem to be enough to cause the disease, even at very high doses.” Clinically relevant nephrotoxicity of gadolinium-based contrast agents was not found.
Thus, the debate over MRI health risks and gadolinium kidney failure continues. MRI remains a vital procedure to identify and eradicate disease. However the risk for MRI and kidney failure remains, leave the patient to potentially choose the lesser of two evils.
Five gadolinium-based contrast agents have been approved for use in the United States: Magnevist (gadopentetate dimeglumine), Ominiscan (gadodiamide); OptiMARK (gadoversetamide); MultiHance;(gadobenate dimeglumine);and Prohance (gadoteridol). Reports have identified the development of NSF following single and multiple administrations of the gadolinium-based contrast agents, with Omniscan as the most commonly reported agent, followed by Magnevist and OptiMARK.
Meta-analysis reveals a strong association between contrast agents and nephrogenic systemic fibrosis
Evidence suggests a potentially causal link between gadolinium-based contrast agents (GBCAs) and nephrogenic systemic fibrosis (NSF) in patients with advanced kidney disease, according to researchers.
Rajender Agarwal, MD, and colleagues at the University of Pennsylvania in Philadelphia performed a systemic review and meta-analysis of controlled studies that have examined the association between GBCAs and NSF. The researchers extracted and analyzed data from seven studies. In four of these, gadodiamide was the sole or predominant GBCA; one study focused only on gadopentetate; and the other studies did not specify the agents that were administered.
Among patients with advanced kidney disease, NSF was 27 times more likely to develop in patients exposed to gadolinium than in those not exposed these agents, researchers reported in Nephrology Dialysis Transplantation (2009;24:856-863).
According to the researchers, evidence supporting a causal relationship includes the following: a significant association demonstrated in six of the seven studies; consistently similar results and large magnitude of effect shown in all studies; a clear temporal relationship found in all but one study; and a dose-response relationship shown in three studies. Two studies did not find this relationship and the other studies did not examine the relationship. In addition, gadodiamide is excreted renally, so it is biologically plausible for it to cause NSF, the investigators observed. Furthermore, gadodiamide is both detectable and quantifiable in the tissues of patients with NSF. Dr. Agarwal’s group also cited a case in which a patient who had clinical resolution of NSF experienced NSF again when re-exposed to gadodiamide.
“Our analyses suggest a potent and significant association between GBCAs and NSF among patients with advanced CKD,” the authors concluded.
Bayer Schering Pharma, Berlin, Germany, manufactures Magnevist; GE Healthcare, Chalfont St. Giles, U.K., is the maker of Omniscan; OptiMARK is manufactured by Mallinckrodt, Inc., Hazelwood, Mo.; and ProHance and Multihance are made by Bracco Diagnostics Inc., Princeton, N.J.
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