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Editorial – May 25, 2017
I am very disappointed and frustrated by the May 22, 2017, FDA Safety Announcement about gadolinium-based contrast agents (GBCAs). I am beginning to wonder how many more people must be adversely affected by retained gadolinium before the FDA decides to take decisive action.
Personally, I don’t blame the FDA or radiologists for what happened to NSF patients. What happened to those patients was terrible, but I want to believe that no one knew then just how unstable the linear agents are, especially when they remain in the body for longer periods of time like they might do in renally-impaired patients. However, once the connection between NSF and GBCAs was discovered in 2006, that all began to change. No longer could the FDA and radiology community say that they didn’t know that gadolinium might be retained from MRI contrast agents or what it might do to the human body when that occurred.
From 2006 until the end of 2013, the FDA and medical community thought that only patients with severe renal problems were at risk of retaining gadolinium. Warnings were issued and action was taken to better screen renally-impaired patients and reports of new cases of Nephrogenic Systemic Fibrosis (NSF) dropped dramatically. However, no one seemed to be investigating what might happen when less gadolinium was retained such as what might occur in patients with “normal” renal function or eGFRs greater than 60.
Since December of 2013 and the first paper by Kanda and his colleagues, the evidence has been mounting that clearly shows that patients with normal renal function retain gadolinium in their brains, bones, and elsewhere in their bodies. This seemed to be news to the FDA and radiology community, but it was something that patients affected by gadolinium have long been trying to tell their doctors. I first brought it to the attention of the FDA in my letter of October 23, 2012. In that letter, I noted that evidence of gadolinium retention in patients with normal renal function was reported by Gibby et al. in 2004 – that was 13 years ago, and it occurred after administration of both a linear and a macrocyclic GBCA.
The published literature clearly states that “gadolinium is toxic”. The FDA has acknowledged that “all GBCAs may be associated with some gadolinium retention in the brain, and other body tissues”. So why is it okay to keep injecting the least stable gadolinium-based contrast agents into patients when it is highly likely that those people are going to retain some unknown amount of a toxic metal? Gadolinium is a toxic metal that has been found to be neurotoxic, to impair mitochondrial function, induce oxidative stress, and much more. Researchers are looking for histological changes in the brain, but what about functional changes? (more…)
On June 24, 2015, the American Board of Magnetic Resonance Safety (ABMRS) administered exams, which will for the first time, certify Magnetic Resonance Medical Directors/Physicians (MRMD) and Magnetic Resonance Safety Officers (MRSO). A third test, for Magnetic Resonance Safety Experts (MRSE), is expected to be ready for administration on or after the 4th quarter of 2015.
As we previously reported, the purpose of the ABMRS is to improve the safety of medical and research magnetic resonance (MR) environments. That includes the safety of MR facilities and the certification and qualification of the professionals who oversee the physical and operational safety of the MR equipment, environment, and processes.
Dr. Emanuel Kanal, ABMRS Chairman, told us that he included in the examination content requirements that ABMRS certified MR practitioners be familiar with gadolinium based contrast agent safety issues – and that among the issues with which they want them to be familiar are long-term potential adverse effects of the administration of gadolinium-based contrast agents. (more…)
On May 5, 2015, Health Imaging published “Q&A: Gadolinium update with leading MRI safety expert Emanuel Kanal, MD”. That same day, an editorial authored by Emanuel Kanal, MD, Director of MR Services at the University of Pittsburgh Medical Center, and Michael F. Tweedle, PhD, Professor and Stefanie Spielman Chair in Cancer Imaging at The Ohio State University Medical School, was published online in Radiology. Their editorial, “Residual or Retained Gadolinium: Practical Implications for Radiologists and Our Patients”, addresses the issue of gadolinium retention in patients with normal renal function. The Q&A is a follow-up to that editorial.
For those who may not be familiar with Dr. ‘Manny’ Kanal, he is a nationally recognized radiologist and a leader in the area of MRI safety. He is the Chair of the founding Board of Directors of the American Board of Magnetic Resonance Safety (ABMRS). Dr. Kanal spoke with Health Imaging for an exclusive interview regarding the new evidence of gadolinium retention and its potential impact on diagnostic imaging and patient safety.
I will not go into all the details of the Q&A here, but there are several interesting comments that Dr. Kanal made that I want to mention.
Regarding the effects of retained gadolinium, Dr. Kanal questioned a comment in an article on Mayo Clinic News Network that was made by one of the authors of the recently published Mayo Clinic study. He said something to the effect of ‘Well, no one has ever shown that this is harmful.’ Dr. Kanal, acknowledged that is true, but, he said, “At the same time, no one has ever studied it to date, so how could they show whether it’s harmful or not?”
When asked how many of the patients who received one or more of the estimated 10 million contrast injections in the U.S. each year could have retained gadolinium in their bodies, Dr. Kanal said, “There is the potential for some level of gadolinium retention for essentially 100 percent of those patients who receive contrast for an MR examination”. (more…)
MRI safety recently took a step forward with the formation of the American Board of Magnetic Resonance Safety (ABMRS). According to its website, the not-for-profit corporation’s purpose is to improve the safety of medical and research magnetic resonance (MR) environments. That includes the safety of MR facilities and the certification and qualification of the professionals who oversee the physical and operational safety of the MR equipment, environment, and processes.
The leadership of the founding Board of Directors includes the following:
- Chair: Emanuel Kanal, MD, Director of MR Services at the University of Pittsburgh Medical Center
- Vice Chair: Max Amurao, Phd, Director of Radiation Safety for Clinical Programs at Columbia University/New York Presbyterian Hospitals
- Secretary/Treasure: Tobias Gilk, MArch, Sr. Vice President of Radiology-Planning and Founder of Gilk Radiology Consulting