MRIs have been used for years to identify medical problems. They have been considered safe and effective, and aside from the occasional bout of claustrophobia for patients, nobody has questioned the risks involved. Unfortunately, that is changing, as more and more health experts grow concerned about the danger associated with the image contrast dye used in MRI testing.
Just recently, two of the industry’s most prominent radiology experts called for more research into the safety of MRI testing. This came after three studies found the potentially toxic metal gadolinium in the brain tissue of MRI patients.
The study has experts questioning if, at least some of the agents used in MRI testing are safe and some have even asked that radiologists alter their prescribing routine. In an editorial in “Radiology,” Dr. Emanuel Kanal from the University of Pittsburgh Medical Center and Michael Tweedle from Ohio State University stated radiologists should not stop using the contrast agents, but they should be aware of the new information and act accordingly.
The Safety of at Least Two Contrast Agents Have Been Called Into Question
Out of the nine gadolinium-based contrast agents available in the United States, two are the subject of criticism. Omniscan, which is made by GE Healthcare and Magnevist, which is made by Bayer HealthCare, have been on the market for several years. Neither company has reported any recent issues with the products, but GE did convene an internal task force to assess the most recent studies and found no evidence of cell toxicity in published autopsies, so it concluded that “continued use of Omniscan according to approved product labeling” is safe.
Despite denial of current problems, Omniscan’s previous issues have been well-publicized. The agent was linked to nephrogenic systemic fibrosis (NSF) in 2006 and received a black box warning from the FDA. At one time, NSF was thought to primarily involve the skin and was originally called nephrogenic fibrosing dermopathy. Doctors now believe it likely involves several internal organs making it a systemic disorder and could lead to a progressive and severe disease course.
Patients with reduced kidney functioned faced the highest risk due to their inability to excrete gadolinium. As a matter of fact, WebMD reports there have been no reported cases of NSF in patients with fully functioning kidneys as of 2014. Because of the risks faced if a patient has kidney issues, doctors now screen patients before MRIs to ensure proper kidney function. Many believed this had been and would be enough to eliminate NSF.
Patients with Healthy Kidneys Appear to Face the Same Risk
The most recent studies have raised concern because they showed that even patients with healthy kidneys could be at risk for retaining gadolinium. Dr. Kanal and Tweedle are speaking out because they don’t understand why, if there are contrast agents available that do not retain gadolinium, why are radiologists still prescribing those that do?
The FDA recently stated it is “carefully reviewing” the data from the most recent studies so it can better understand the issues and determine if further action is warranted. Dr. Kanal, himself an advisor to the FDA, stated the latest information has “the entire international radiological community – and the FDA – on edge, as this is an entirely unanticipated finding.”
Lawsuits Have Been Settled and More are in the Works
Despite publicly denying problems, both Bayer and GE have privately settled hundreds of lawsuits associated with the contrast agents. Many were wrongful death suits filed by patients’ loved ones.
One Cleveland case went to trial in 2013 and resulted in a $5 million verdict against GE. The verdict was upheld by a federal appeals court last year, but by the end of the appeals process the plaintiff had died.
Another potential lawsuit involves Marcie Jacobs, a woman who began undergoing MRIs in 2001 to closely monitor her breast cancer risk. As the MRIs continued over the years, Jacobs noticed her cognitive function declining. She eventually ended up on disability and after a series of test, found that her symptoms were caused by an accumulation of gadolinium in her breast, livers, thighs, and brain.
Jacobs is a perfect example of why the most recent studies are relevant – she had no history of kidney disease, but had received Omniscan for her first 11 MRIs and Magnevist for at least one of her final tests. She is hoping the FDA will pull both agents from the market and that others will not be forced to endure the illness and arduous task of removing gadolinium from their bodies, as she was forced to do.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.