Petition update

Chuck Norris Takes on the FDA

MedInsight Research Institute

Sep 19, 2017 — In follow-up to our last update, Chuck Norris recently reported in about an FDA special advisory committee meeting held earlier this month regarding the safety of gadolinium-based contrast agents.

To recap:

In 2006, data revealed that there was a strong association between gadolinium contrast agents and nephrogenic systemic fibrosis, a kidney disease.

In 2007, the FDA issued a “black box warning” to those with compromised renal function to avoid gadolinium.

In 2015, the FDA issued another warning that gadolinium could remain in the body, even in patients with normal kidney function.

In May 2017, results of a 2-year study resulted in the FDA reporting that it had “not found any evidence of adverse events from the brain’s retention of gadolinium after MRI”.

Also, in May, the European Medicines Agency Committee recommended that the use of one type of gadolinium, the linear type, be suspended.

Earlier this month, the FDA held a public meeting to discuss the safety of gadolinium. Chuck Norris and his wife attended and presented their case, Gena’s serious gadolinium-related illness.

On September 11, 2017, the committee voted 13-1, with one abstention, to recommend that prescribing information should include “a warning for retention for all gadolinium-based contrast agents (GBCAs) with greater retention of all or some of the linear GBCAs compared to the macrocyclics in certain organs including the brain and that ‘risk minimization steps’ be taken for certain patient populations”.

Dr. Alicia Y. Toledano, a Harvard University trained expert in radiology, was the committee member who voted no. She explained that the warning was insufficient. She stated that “people need to know, not just the doctors, and I don’t think this plan is sufficient”.

After hearing Gena’s story, Dr. Toledano stated that “it is hard to dismiss an anecdotal report when you are the anecdote. A life ruined is a life ruined. What does a patient do when doctors and everyone else she turns to for help poo-poos her concerns and doesn’t order a test, a simple urine test? When a patient is finally tested and is found to have gadolinium retention, when there’s no FDA antidote, what does that patient do? The disconnect noted in Gena Norris’ statement is so true all across this country every single day”.

Dr. Toledano posed questions such as, who is the prescriber, the one who chooses the agent, who sets the dose, who orders the imaging? Whomever these people are, they most likely will not be able to request a specific agent or dose. And how often do patients see any labeling? She voted no because she felt that the FDA warning was insufficient.

You can watch Dr. Toledano’s testimony above.

Please join the growing list of advocates and sign our petition so we can help promote the development of safer alternatives and effective treatments to remove gadolinium from patients affected by it.

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