By: Staff Writers | Published: July 5th, 2010
Ominscan, Magnevist and Optimark are the three gadolinium-based MRI contrast agents associated with the highest number of nephrogenic systemic fibrosis (NSF) cases, according to new radiology industry safety standards.
In a new safety manual on the use of MRI contrast agents, which are injected prior to an MRI to improve the results of imaging scans, the American College of Radiology (ACR) identified the three products as those most frequently associated with the rare and often fatal condition that is associated with the hardening and thickening of the skin, which severely restricts movement. ACR said that investigators now believe that the “intrinsic properties” of those three products increases the likelihood of at-risk patients developing NSF.
The most cases by far were associated with GE Healthcare’s Omniscan MRI Contrast, which was linked to at least 382 cases of NSF out of approximately 13 million doses. By comparison, the second highest number of cases was associated with Bayer’s Magnevist MRI contast, which had 195 cases of NSF out of approximately 23 million doses. The third highest was OptiMARK MRI contrast by Covidien, which was linked to 35 cases of NSF out of 4.7 million doses.
ACR noted that the difference in rates between those three and other gadolinium-based contrasting agents could be due to both toxicity and market share.
NSF, which is sometimes referred to as nephrogenic fibrosing dermopathy (NFD), is a rare condition that is only known to occur after exposure to a gadolinium-based contrast agent (GBCA) among individuals with impaired kidney function. There is no cure for the painful and debilitating condition, and in many cases it results in death over time.
The manufacturers of all types of gadolinium-based agents were required by the FDA to add the same “black box” warning about the risk of NSF from MRI with contrast in the United States in 2007, indicating that individuals with severe kidney problems could develop NSF. However, many have argued that the warnings about Omniscan side effects should be stronger than those on other available contrast agents, possibly calling for a ban on use of the product in some patients.
Hundreds of nephrogenic systemic fibrosis lawsuits 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 lawsuits over 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.