On October 23, 2012, our efforts to bring attention to the issue of gadolinium retention in patients with normal renal function began with a letter I wrote to the FDA. Because of the significance of that letter and its relevance to our ongoing work in patient advocacy, education, and research, I have decided to make it available to the public by posting a PDF of it here on www.GadoliniumToxicity.com.
As you will see, the issue of gadolinium retention is not something new.
When I wrote the letter to FDA Commissioner Margaret A. Hamburg, M.D., the only gadolinium-related problem recognized by the FDA and medical community was Nephrogenic Systemic Fibrosis (NSF), and it was widely published that it only occurred in people with severely impaired renal function. Patients with an estimated glomerular filtration rate greater than 60 (eGFR >60) were routinely told they would not retain gadolinium. Despite urine test results which showed elevated levels of gadolinium months and even years after their contrast procedures, people with normal renal function continued to be told that their unexplained symptoms could not be caused by the gadolinium-based contrast agent they had received for their MRI.
My research of the literature published prior to 2012 seemed to indicate otherwise, and I believe that more recently published studies have confirmed my concerns and those expressed by other affected patients. Published evidence of gadolinium retention in patients and animals with normal renal function has existed for quite some time. The toxic effects of gadolinium are also well-documented.
I have been in periodic contact with someone at the FDA since early 2013. Though I believe that the FDA seriously considered my letter, it took until July 27, 2015 to issue its first Safety Announcement regarding gadolinium retention in patients with normal renal function. Research is ongoing; however, in my opinion, it is moving much too slowly all while patients continue to be adversely affected. As I stated in my letter, “I believe the already published scientific data related to Gadolinium-Based Contrast Agents and the toxic effects of free Gadolinium call into serious question the long-term safety of using these contrast agents in all patient populations. Based on the totality of the facts, I believe immediate action by the FDA is warranted.” I said that in 2012, and I believe that even more strongly now in 2016.
Here we are 4 years later and we are still talking about the problem. I believe that it is time for action on the part of the FDA and the medical community.
You can download a copy of my 2012 Letter to the FDA regarding gadolinium retention that includes an introduction with my comments. I ask that you please honor the copyright notice in the document.