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Apr 13, 2019 02:30PM
Apr 13, 2019 06:26PM
Good report, Faithopelove! Gadolinium is used in breast MRIs and other MRIs to enhance what is seen. Questions about its safety are now being raised. This is a very helpful document.
3 w's then dot then itnonline.com/article/debate-over-gadolinium-mri-contrast-toxicity
Excerpts from this linked document:
"Radiologists and patients began to question the safety of gadolinium a few years ago when a study came out in late 2014 showing the agent is deposited and retained in the brain. This, combined with a small percentage of patients who claim their health was harmed following gadolinium exams..."
"It is known that patients with renal insufficiency cannot filter the gadolinium from their body, so it is included as a U.S. Food and Drug Administration (FDA) warning label on the contrast packaging. But, there has been little evidence showing patient safety issues in those with normal renal function."
"November 2017...action movie actor Chuck Norris filed a lawsuit against a contrast vendor and the contrast distributor for allegedly poisoning his wife Gena. She had several contrast MRI exams and the suit alleges numerous adverse health effects began after these exams. Norris is seeking $10 million in damage." %%%%THIS IS THE BIG DRIVER OF THE CHANGES WE HAVE SEEN IN WHAT WE SIGN AND IN INVESTIGATIONS INTO THE SAFETY OF THE DYE%%%%%
"Physicians have largely been reluctant to directly link gadolinium agents to these maladies, because there is little clinical evidence showing a direct correlation. Symptoms can also vary greatly between patients reporting problems. Gadolinium contrast agents have been used in hundreds of thousands of patients over the past couple decades and the clinical evidence shows it is safe in most patients...Until the past few years, it was not widely known that the gadolinium accumulated and was retained in tissues, especially the brain...It was previously thought the agent was entirely excreted from the body.. A couple large scale studies are underway, but it will take time to gather data to determine the long-term effects of gadolinium retention.
"I am not completely convinced gadolinium is not toxic," Kanal [Emanuel Kanal, M.D., director of MRI services and professor of radiology and neuroradiology at the University of Pittsburgh Medical Center] said. "I don't know which way to turn yet. The issue is a lack of data showing toxicity, but lots of data showing it is safe."
"Sheela Agarwal, M.D., U.S. medical affairs, Bayer Healthcare, who spoke during a Bayer-sponsored lunch at RSNA on the topic of gadolinium safety...said there have been about 50 studies that have come out on this subject in the past few years, but none of them offer a smoking gun showing gadolinium retention leads to chronic disease."
"What is the FDA Doing About Gadolinium Toxicity Concerns? The FDA agrees that more research is needed and there is not enough evidence to impose a regulatory clampdown on GBCAs. In September 2017, the FDA's Medical Imaging Drugs Advisory Committee (MIDAC) voted overwhelmingly to recommend new labels on gadolinium-based contrast agents (GBCAs) warning of the possibility of gadolinium retention in the body"
"The FDA stated there is no clinical evidence that directly links gadolinium retention to adverse health effects in patients with normal kidney function, and the FDA has concluded that the benefit of all approved GBCAs continues to outweigh any potential risks."
"The health consequences, if any, are as of yet entirely unknown, and so far there are no known consequences of retained gadolinium," Kanal [Emanuel Kanal, M.D., director of MRI services and professor of radiology and neuroradiology at the University of Pittsburgh Medical Center] said. "It does not mean that there are none, it just means that we don't know of any at this stage and more studies are needed."
"However, in July 2017, the European Medicines Agency (EMA--European Medicines Agency) issued a final opinion that recommended restricting the use of some linear gadolinium-based contrast agents (GBCAs) and suspending the marketing authorizations of others, citing concerns about gadolinium deposition. But, the EMA said it supports the continued use of macrocyclic GBCAs. The EMA stated "there is currently no evidence that gadolinium deposition in the brain has caused any harm to patients.
"The EMA recommended suspending the marketing authorizations of GBCAs Magnevist (gadopentetate dimeglumine), Omniscan (gadodiamide) and OptiMark (gadoversetamide). The group cited the benefit-risk balance is no longer favorable for certain linear GBCAs. But, the EMA recognized certain linear GBCAs are still needed for liver imaging, so retained Primovist (Eovist in the U.S., gadoxetate disodium) and MultiHance (gadobenate dimeglumine)."
"There are two classes of GBCAs based on their chemical shape — linear and macrocyclic agents. Agarwal (M.D., U.S. medical affairs, Bayer Healthcare) said there are four studies[6,7,8,9] that have shown linear agents have more retention in the brain than macrocyclic agents. However, recent studies have also shown all agents, including macrocyclic, leave gadolinium behind in the brain to some level. While deposition in the brain has been the main reason for concern in recent years, she said in animal studies, there was 100 times more gadolinium retained in skin and bones than there was in the brain. SEE LIST AT END
>>>HERE IS WHY YOU ARE BEING ASKED TO SIGN SOMETHING. I HAD TO SIGN IT TOO.<<<
"Some practices are looking into informed consent documentation, but others do not want to do this because of fears it may open the door to litigation"
I don't have the source, but I copied this into my own Gadolinium files:
The macrocyclic agents are shaped like cages around the gadolinium ion and have a lower probability of releasing free gadolinium. They are considered more stable than other contrast agents and have a lower risk of NSF-- Nephrogenic systemic fibrosis. The linear nonionic agents are the least stable, and the linear ionic agents have intermediate stability. For example, the vast majority of patients with NSF have been exposed to the linear nonionic agent, Omniscan (gadodiamide), even though it only has about 15% of the worldwide market share of gadolinium-based contrast agents.
I will be asking specifically what kind of Gadolinium is being used in my MRIs, and will consult the list at the bottom. I've had one MRI only so far. I have asked several docs about Gadolinium over the past 18 months and here are the responses.
Gynocologist--"Do they need dye for breast MRIs? I did not think they did."
This response surprised me and shows how localized doctors' knowledge can be. Dye IS used for breast MRIs.
Breast Surgeon--"An MRI without gadolinium is not worth doing. The safety is something to consider." When I became a little desperate, maybe a little hyperventilating and said something like, "All the more reason to remove my breasts if I can't do MRIs now because they are not safe which takes away one of my best weapons for early detection," the surgeon very nicely let me know she thought I was way over reacting and the benefits still outweigh the risks.
Family doc--"This risk is low. Keep doing your breast MRIs."
Cancer specialty and research center--"We use the safest gadolinium. We do not see problems with it." This is where I got my one and only MRI. But I plan to do annual ones there.
Nurse Practitioner specializing in high risk for breast cancer--don't remember her exact words be she felt it tipped the balance away from doing annual MRIs over a lifetime, but the occasional MRI was still ok.
One of the professionals, but I don't remember who and cannot find it written down said, the biggest concern is for MRIs OF THE BRAIN, not so much for other areas.
The List from the linked article
Linear GBCAs:---shown as more dangerous-- Ablavar (gadofosveset trisodium)
• Eovist (gadoxetate disodium)
• Magnevist (gadopentetate dimeglumine)
• MultiHance (gadobenate dimeglumine)
• Omniscan (gadodiamide)
• OptiMark (gadoversetamide)
Macrocyclic GBCAs:---little less dangerous---
• Dotarem (gadoterate meglumine)
• Gadavist (gadobutrol)
• ProHance (gadoteridol)
"It's always something" ~Roseannadanna
(in retrospect, a rather poignant quote, considering the source)