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2012 Letter to FDA about Gadolinium Toxicity is available to the public
On October 23, 2012, I sent a detailed letter to the FDA which expressed my concerns about gadolinium toxicity caused by retained gadolinium from Gadolinium-based Contrast Agents (GBCAs). Because of the many recently published studies about gadolinium deposition in the brain and bones of patients with normal renal function, I decided that it was the right time to make my letter available to the public. While some progress has been made, four years have passed since I wrote that letter and I am concerned that the full scope of the problem still might not be addressed.
While I believe that the FDA took my concerns about gadolinium retention seriously, things are moving much too slowly. By making my letter public, I hope it will stimulate more interest in the issue of gadolinium retention and the plight of the many patients who have been adversely affected by its toxic effects.
You can download a copy of my 2012 Letter to the FDA in the Advocacy section. Please share it with your doctors and other affected patients.
To the medical professionals that follow us, I hope you will take time to read my entire letter. I am not a trained medical professional or scientist. However, I believe you will find my comments well-reasoned and fact-based.
Sharon Williams
Q&A with leading MRI Safety Expert Emanuel Kanal, MD
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…)
Residual or Retained Gadolinium in Patients with Normal Renal Function – What happens next?
On May 5, 2015, an editorial by Emanuel Kanal, MD, Director of Magnetic Resonance Services and Professor of Radiology and Neuroradiology 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 ahead of print. The editorial, “Residual or Retained Gadolinium: Practical Implications for Radiologists and Our Patients”, is in the June 2015 issue of Radiology. It addresses the issue of gadolinium retention in patients with normal renal function, as evidenced by published findings by Kanda et al, Errante et al, Quattrocchi et al, McDonald et al, and Radbruch et al.
In December of 2013, a study by Kanda et al first brought attention to what appeared to be evidence of residual gadolinium within the brain tissues of patients without severe renal disease. The evidence of gadolinium in the brain started with reports of abnormal signals in the globus pallidus and the dentate nuclei on unenhanced T1-weighted MR images after repeated prior administration of certain gadolinium-based contrast agents or GBCAs. Other studies found measureable concentrations of gadolinium in normal brain tissues from patients with normal renal (kidney) function. In their editorial, Kanal and Tweedle said, “These provocative findings cause us to reconsider what we know and what we need to learn to better care for our patients”.
The authors said, “We now have clear evidence that the administration of various GBCAs results in notably varied levels of accumulation of residual gadolinium in the brain and bones of patients, even those with normal renal function. What we still do not know is the clinical significance, if any, of this observation.” (more…)
Reports of Gadolinium Retention in brain tissues of patients with normal renal function raise safety concerns
Several recent studies that involve Gadolinium-based Contrast Agents used for enhanced MRIs have gotten the attention of the radiology community. The findings of all the studies indicate that Gadolinium-based Contrast Agents, or GBCAs, might not work exactly as everyone thought they did. The recent Mayo Clinic study by McDonald et al appears to confirm that at least some gadolinium from the intravenously administered GBCA can remain in brain tissues of patients – including in patients with normal renal function. Based on reports of increasing T1 signal intensity on unenhanced magnetic resonance images (MRI) in patients who had multiple MRIs with a GBCA, it appears that once deposited, gadolinium accumulates in the brain tissue. (Recent studies cited at end.)
Prior to the publication of these studies, patients with normal renal function had been told that their unexplained, chronic symptoms could not be from retained gadolinium; however, the findings of the recent studies cast serious doubt on that. The findings seem to support what patients with normal renal function have been saying for years now – they are retaining gadolinium from the GBCA administered for their MRIs and they are experiencing troubling symptoms because of it.
Recently I had the opportunity to provide some information for a story about GBCA safety that John Hocter, managing editor of Health Imaging, was writing. The recent publication of his article brought the plight of patients with normal renal function to a broader and more public audience. Also contributing to the article was Tobias Gilk, a leading MRI Patient-Safety advocate and member of the newly formed American Board of MR Safety. (more…)
Gadolinium Toxicity 