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FDA Public Meeting about Risk of Gadolinium Retention from GBCAs
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.
Open Letter to the FDA about Gadolinium-based Contrast Agents
Editorial – May 25, 2017
Sharon Williams
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…)
Help Fund a Gadolinium Toxicity Researcher
The Berkeley Labs Foundation is raising $120,000 for a full-time researcher who will be dedicated to understanding and treating gadolinium toxicity.
I hope you will consider making a tax-deductible donation and sharing this information with your family, friends, and doctors too.
You can find out about the fundraising effort here: http://www.berkeleylabfoundation.org/support-berkeley-lab/ Gadolinium Toxicity is the entry to the far-right and the “Donate” button is above it.
On behalf of affected patients around the world, thank you for donating! No amount is too small to give.
Sharon Williams
European group recommends to stop using 4 linear GBCAs
March 10, 2017 – A committee of the European Medicines Agency (EMA) has recommended the suspension of the marketing authorizations for four linear gadolinium-based contrast agents (GBCAs) used for MRI scans because of concerns about small amounts of gadolinium from administered GBCAs being deposited in the brain.
At the completion of its year-long review of GBCAs, the EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) “found convincing evidence of accumulation of gadolinium in the brain from studies directly measuring gadolinium in brain tissues and areas of increased signal intensity seen on MRI scan images many months after the last injection of a gadolinium contrast agent”.
Linear agents recommended for suspension by the PRAC are:
Gadobenic acid, marketed as MultiHance by Bracco Diagnostics Inc.
Gadodiamide, marketed as Omniscan by GE Healthcare
Gadopentetic acid, marketed as Magnevist by Bayer HealthCare Pharmaceuticals
Gadoversetamide, marketed as OptiMARK by Mallinckrodt Inc.
The PRAC’s final recommendations will be sent to the Committee for Medicinal Products for Human Use (CHMP) for its opinion. Further details will be published when CHMP renders its opinion regarding the removal of the four linear agents from the market.
In its press release, the PRAC noted that deposition of gadolinium in other organs and tissues has been associated with rare side effects of skin plaques and Nephrogenic Systemic Fibrosis (NSF). It also noted that “non-clinical laboratory studies have shown that gadolinium can be harmful to tissues”.
The PRAC said that two linear agents will remain available: gadoxetic acid (brand name Eovist), used at a low dose for liver scans, since it meets an important diagnostic need in patients with few alternatives, and a formulation of gadopentetic acid injected directly into joints because its gadolinium concentration is very low. The PRAC indicated that both agents should be used at “the lowest dose that enhances images sufficiently to make diagnoses and only if unenhanced scans are not suitable”.
FDA actions
On July 27, 2015, the FDA issued its first, and so far only, Safety Announcement regarding gadolinium retention in the brain following repeated use of a GBCA for MRIs. It acknowledged that trace amounts of gadolinium may stay in the body long-term, and noted that “recent studies conducted in people and animals have confirmed that gadolinium can remain in the brain, even in individuals with normal kidney function”.
The 2015 announcement said that the FDA, including its National Center for Toxicological Research (NCTR), “will study this possible safety risk further”. As of this writing, the FDA has made no further public safety announcements regarding the use of gadolinium-based contrast agents.
It remains to be seen if the FDA will follow the lead of the EMA and suspend the use of the linear GBCAs. Three of the four suspended agents are linked to the most unconfounded cases of NSF, and they are among the most widely used GBCAs for magnetic resonance imaging (MRI) procedures.
Sharon Williams
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PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations. EMA/157486/2017. http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2017/03/WC500223209.pdf
Gadolinium Toxicity 