NSF Cases Disappeared Following MRI Contrast Guidelines: Study

Restrictive guidelines put in place on gadolinium-based contrast agents (GBCAs) used during some MRI examinations appear to be working, according to the findings of U.S. researchers, who report that they have not identified any new cases of nephrogenic systemic fibrosis (NSF) among individuals who received an enhanced MRI with contrast after the guidelines were adopted. 

Researchers looked at nearly 53,000 cases where patients were given a gadolinium contrast agent between 2008 and 2010, and found no reports of new cases of NSF, a disabling and potentially life-threatening condition known to occur among some patients given gadolinium contrast. The findings were published online last month by the medical journal Radiology.

Gadolinium-based contrast agents are solutions given to patients before they take a magnetic resonance image (MRI) in order to get better results. However, use of the agents among patients with impaired kidney function has been linked to a risk of NSF. In 2007, the FDA limited gadolinium contrast agent doses in most patients and contraindicated it for others.

After the restrictive guidelines were adopted, researchers report that the condition has disappeared among the cases evaluated, which included many patients who may have otherwise been more susceptible to NSF.

In September 2010 the FDA went even further and banned the use of Bayer’s Magnevist on patients with kidney problems due to the risk of NSF. The agency also put similar restrictions on GE Healthcare’s Omniscan and Covidien’s Optimark.

The agency also required label changes to all gadolinium-based contrast agents (GBCAs) warning healthcare professionals to screen patients before injecting a GBCA to identify those suffering from acute kidney injury or chronic, severe kidney disease.

Sometimes referred to as nephrogenic fibrosing dermopathy (NFD) or gadolinium associated systemic fibrosis, NSF is a painful disorder that causes a hardening and thickening of the skin and other tissue in the body. There is no known cure for the disease and it often leads to death.

Several hundred lawsuits over nephrogenic systemic fibrosis have been filed in the United States by individuals who developed the condition after receiving a gadolinium-based contrast agent. Out of the five approved contrast agents, Omniscan has been associated with the most cases of NSF, outnumbering the other drugs in proportions that far exceed their market share. It has been estimated that about 75% of all NSF lawsuits involve cases where the plaintiff developed the condition after use of Omniscan, even though GE’s contrast agent only accounts for about 30% of the market share.