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Coauthors of The Lighthouse Project provide facts about Gadolinium Toxicity to FDA Advisory Committee
As coauthors of The Lighthouse Project, we have provided written comments about the toxic effects of gadolinium and gadolinium retention in patients with normal renal function to the FDA’s Medical Imaging Drugs Advisory Committee in advance of its September 8, 2017 meeting. We will be making a brief oral presentation during the Open Public Hearing portion of the meeting which will be held at the FDA’s White Oak Campus in Silver Spring, Maryland.
Our comments are built around the following 6 major points that we cover in making the case that the FDA needs to take action regarding the use of Gadolinium-based Contrast Agents (GBCAs) administered for contrast-enhanced MRIs.
1. Medical literature documents toxicity of gadolinium and systemic implications.
2. The Risk Factors for adverse results are many.
3. NSF-Like Symptoms in patients with normal renal function.
4. Gadolinium from GBCAs does not clear the body in a few days, or even in a few months, allowing plenty of time for the Gd ion to dissociate from the chelate.
5. Underreported Symptoms from Contrast MRIs is a serious problem.
6. There is evidence of clinical implications of gadolinium deposition.
Our detailed comments can be found here: Comments-from-Lighthouse-Project-FDA-2017-N-1957 . We also included the following supporting materials:
- Sharon’s 2012 Letter to the FDA (SWilliams-2012FDALetter-FDA-2017-N-1957)
- Our Symptom Survey of the Chronic Effects of Retained Gadolinium from Contrast MRIs (Lighthouse Symptom Survey copy for Docket FDA-2017-N-1957), and
- Our most recent report, Gadolinium Retention from Contrast MRIs in 70 Cases with Normal Renal Function – 24-hour Urine Test Results (Lighthouse 70 Case Retention Study copy for Docket FDA-2017-N-1957)
We will report back later about our experience at the FDA Advisory Committee Meeting.
Sharon Williams and Hubbs Grimm
On September 8, 2017, the FDA’s Medical Imaging Drugs Advisory Committee (MIDAC) will meet to discuss the potential risk of gadolinium retention in the brain and other body organs in patients receiving gadolinium-based contrast agents (GBCAs) for MRI procedures.
During the Open Public Hearing (OPH) portion of the meeting, 75 minutes have been allotted to interested persons to present data, information, or views, orally or in writing. The deadline for requesting time to speak has passed. However, interested parties have until September 7, 2017 to submit electronic or written/paper submissions related to the issue of gadolinium retention. Note that the Docket No. for the meeting is FDA-2017-N-1957 and it must be included on all submissions
An updated announcement about the meeting can be found here: https://www.fda.gov/AdvisoryCommittees/Calendar/ucm571112.htm
CDER (Center for Drug Evaluation and Research) plans to provide a live webcast of the September 8, 2017 MIDAC meeting. Information about the web address for the webcast will be made available at least 2 days before the meeting. See the updated announcement for more information about the webcast.
The Medical Imaging Drugs Advisory Committee Meeting Briefing Document titled, Gadolinium Retention after Gadolinium Based Contrast Magnetic Resonance Imaging in Patients with Normal Renal Function, is available for download: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/MedicalImagingDrugsAdvisoryCommittee/UCM572848.pdf
Sharon Williams and Hubbs Grimm have submitted comments and supporting materials from The Lighthouse Project at GadoliniumToxicity.com for Docket No. FDA-2017-N-1957.
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…)