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FDA makes change to GBCA Medication Guide requirement

On December 19, 2017, the FDA issued a new Safety Announcement related to gadolinium-based contrast agents (GBCAs) administered for MRIs.  One of the actions described in the announcement was the requirement that every patient be given a Medication Guide to read before receiving a GBCA.  The Medication Guides for all GBCAs are now available.  However, on May 16, 2018, the FDA issued an Update to the requirement that patients be given the Medication Guides prior to their MRIs.

It appears that the FDA has determined that, “hospital inpatients are not required to receive a Medication Guide unless the patient or caregiver requests it”.

Since most people are not aware that patients are retaining gadolinium from GBCAs administered for MRIs or that gadolinium is a toxic metal, they will not know to ask for a copy of the Medication Guide or that one even exists.  That will result in a vulnerable population of patients not being fully-informed about the potential risk of gadolinium deposition in their brain, bones, skin, and other tissues.

As documented in the medical literature, patients in hospitals are at greater risk of having an acute kidney injury or AKI which can impair patients’ kidney function and potentially cause them to retain more gadolinium.  I believe that patients in hospitals and/or their families should be informed about that risk and they should be given a Medication Guide for the GBCA that will be administered for any inpatient imaging procedures.

The following is the FDA’s May 16, 2018 Update – (more…)

FDA’s response to GBCA Safety Issues – More warnings and a Medication Guide

On December 19, 2017, the FDA issued an update to its Drug Safety Communication regarding brain retention of gadolinium-based contrast agents (GBCAs) used for MRIs.  Despite mounting evidence that GBCAs leave gadolinium in the brain, bones, and other tissues of all patients who undergo MRIs with contrast, the FDA has decided not to suspend the use of any GBCAs.  This is in stark contrast to the actions taken by the European Medicine’s Agency and the U.K.’s Medicines and Healthcare Products Regulatory Agency.   Those agencies suspended the use of the linear agents Magnevist, Omniscan, and OptiMark, while requiring changes to all GBCA product labeling. The Japanese Ministry of Health, Labour and Welfare restricted the use of non-specific linear GBCAs only to cases where there is no alternative and it also required changes to product labeling.

In its Safety Alert, the FDA acknowledged that “linear GBCAs result in more retention and retention for a longer time than macrocyclic GBCAs”.  However, the FDA concluded that “the benefit of all approved GBCAs continues to outweigh any potential risks”.  This action was taken despite “reports of adverse events involving multiple organ systems in patients with normal kidney function”.

In response to the issue of gadolinium retention, the FDA is requiring several actions to alert health care professionals and patients about gadolinium retention after an MRI using a GBCA.  These include requiring a new patient Medication Guide for each agent, providing educational information that every patient will be asked to read before receiving a GBCA, and taking actions that can help minimize problems.  The FDA is also requiring manufacturers of GBCAs to conduct human and animal studies to further assess the safety of gadolinium-based contrast agents.  Product labeling for all GBCAs must be changed to include new warnings and precautions.

Each GBCA will have a patient Medication Guide with agent specific information, and content that is required for all gadolinium-based contrast agents; the Medication Guide for MultiHance and ProHance have recently been released.  The Radiology Department of each institution will create educational handouts that every patient will be asked to read before signing the consent form for his or her MRI or MRA with a GBCA.

Patients must be fully-informed about potential risks. (more…)

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

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.

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