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The results of a chelation study using Ca-/Zn-DTPA to treat 25 patients diagnosed with Gadolinium Deposition Disease (GDD) will be published in the June 2018 issue of Investigative Radiology. The complete article is not freely available to the public. However, you can find the abstract of, “Intravenous Calcium-/Zinc-Diethylene Triamine Penta-Acetic Acid in Patients with Presumed Gadolinium Deposition Disease – A Preliminary Report on 25 Patients”, by Semelka et al. at https://www.ncbi.nlm.nih.gov/pubmed/29419708
According to the FDA, Calcium-DTPA (Ca-DTPA) and Zinc-DTPA (Zn-DTPA) are drug products that have been used for over 40 years to speed up excretion of the actinide elements plutonium, americium, and curium from the body. Gadolinium (Gd) is a lanthanide series element that shares a number of chemical properties with actinides. The purpose of the study was to determine if the FDA-approved actinide metal decorporation agents Ca-/Zn-DTPA could be beneficial for symptomatic patients with GDD who had retained gadolinium from the gadolinium-based contrast agents (GBCAs) that had been administered for their MRIs. (more…)
On September 8, 2017, after a day filled with presentations by drug industry representatives, medical professionals, FDA personnel, and people who have been affected by retained gadolinium, the FDA’s Medical Imaging Drugs Advisory Committee (MIDAC) took two important votes related to gadolinium-based contrast agents (GBCAs) and gadolinium retention.
First, MIDAC members agreed with the FDA’s plan to “revise the prescribing information for GBCAs as a class to include: a warning for retention for all GBCAs, with greater retention of all or some of the linear GBCAs compared to the macrocyclics in certain organs including the brain; recommended risk minimization steps for certain patient populations”. From the discussions, those populations appear to be pregnant women and children.
Second, MIDAC members agreed, that pending the results of a number of ongoing clinical and preclinical studies, the FDA “might request that manufacturers conduct additional studies that will inform our decisions about the need for further regulatory actions including withdrawal of approval and restriction of indicated populations”.
During his comments to the committee, Dr. Emanuel Kanal formally recommended that “the FDA encourage and/or support formal investigation” of our group. We hope that one or more additional studies will include members of our MRI-Gadolinium-Toxicity support group. We fully support Dr. Kanal’s recommendation since we believe people who have been affected by retained gadolinium can provide important data that is not available anywhere else.
During the meeting, no one disputed that gadolinium is toxic or that everyone who has an MRI with contrast retains an unknown amount of gadolinium. However, there is still disagreement about what, if any, long-term harm retained gadolinium might do to a patient, including someone who has evidence of gadolinium retention months and even years after his or her last contrast-enhanced MRI.
Until the September 8th MIDAC meeting, patients who believe they have been adversely affected by retained gadolinium have been left to their own devices to try to get their chronic health issues recognized as being caused by gadolinium toxicity and to find a way to remove gadolinium from their bodies. Hopefully, that will soon change.
The Center for Drug Evaluation and Research (CDER) provided a live webcast of the September 8, 2017, MIDAC meeting. A recording of the webcast can be found at the four following addresses:
Start of Meeting to Morning Break: https://collaboration.fda.gov/p7goy94tum9/
Morning Break to Lunch Break: https://collaboration.fda.gov/p25a1oiwhqd/
Lunch Break to Afternoon Break: https://collaboration.fda.gov/p96q45ae2t3/
Afternoon Break to End of Meeting: https://collaboration.fda.gov/p1qe35bmdkj/
Hubbs Grimm and I, representing The Lighthouse Project and other affected patients, are speaker #2 in the Lunch Break to Afternoon Break video. That video includes all presentations made during the Open Public Hearing portion of the meeting.
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…)