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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.