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FDA Advisory Committee votes to revise warnings for all gadolinium-based contrast agents
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.
Sharon Williams
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
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.
Gadolinium Toxicity 