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» LymeNet Flash » Questions and Discussion » General Support » Gadolinium MRI / MRA Contrast Agents - FDA Warning

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Author Topic: Gadolinium MRI / MRA Contrast Agents - FDA Warning
Keebler
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Please save this to your computer's personal medical research folder for easy reference. And please share with others, too.


. . . Gadolinium from Gadolinium-Based Contrast Agents (GBCAs) used for contrast-enhanced MRIs and MRAs. . . .


. . . regarding gadolinium remaining in the body (brain) for months or years after receipt of the agent . . . .


https://www.medscape.com/viewarticle/890359?nlid=119683_3901&src=wnl_newsalrt_171219_MSCPEDIT&uac=3307DR&impID=1512921&faf=1

FDA to Require Warning Labels on Gadolinium-Based Contrast Agents

Megan Brooks - Medscape / DISCLOSURES - December 19, 2017

The US Food and Drug Administration (FDA) will require:

* a new class-wide warning for all gadolinium-based contrast agents (GBCAs)

regarding gadolinium remaining in the body for months or years after receipt of the agent,

the agency said in an updated drug safety communication issued today.

* The FDA will also require a new medication guide that providers should give to patients in advance of receiving a GBCA.

* And GBCA manufacturers will be required to conduct further studies to assess the safety of this class of contrast agents. . . .

[Full article at link above with

Eight drugs listed in CHART of GBCA agents by Rx generic & brand names, and by classification.]
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[ 12-19-2017, 04:34 PM: Message edited by: Keebler ]

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Keebler
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https://en.wikipedia.org/wiki/Gadolinium

Gadolinium [Wikipedia]

Excerpts:

Gadolinium is a chemical element with symbol Gd and atomic number 64. Gadolinium is a silvery-white, malleable, and ductile rare earth metal.

It is found in nature only in oxidized form, and even when separated, it usually has impurities of the other rare earths. . . .

. . . The kinds of gadolinium(III) ions occurring in water-soluble salts are toxic to mammals.

However, chelated gadolinium(III) compounds are far less toxic because they carry gadolinium(III) through the kidneys and out of the body before the free ion can be released into the tissues.

Because of its paramagnetic properties, solutions of chelated organic gadolinium complexes are used as intravenously administered gadolinium-based MRI contrast agents in medical magnetic resonance imaging. . . .

. . . Although gadolinium agents are useful for patients with renal impairment, in patients with severe renal failure requiring dialysis, there is a risk of a rare but serious illness called

nephrogenic systemic fibrosis (NSF)[31] or nephrogenic fibrosing dermopathy,[32] that is linked to the use of MRI contrast agents containing gadolinium.

The disease resembles scleromyxedema and to some extent scleroderma.

It may occur months after a contrast agent has been injected.

Its association with gadolinium and not the carrier molecule is confirmed by its occurrence with various contrast materials in which gadolinium is carried by very different carrier molecules.

Due to this, it is not recommended to use these agents for any individual with end-stage renal failure as they will require emergent dialysis.

Similar but not identical symptoms to NSF may occur in subjects with normal or near normal renal function within hours to 2 months following the administration of GBCAs;

the name "gadolinium deposition disease" (GDD)

has been proposed for this condition, which occurs in the absence of pre-existent disease or subsequently developed disease of an alternate known process.

The causal relationship was being investigated as of May 2016; preliminary investigation suggested a true disease process.[26][33] . . . .

[Full entry at link above.]
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Keebler
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https://gadoliniumtoxicity.com/

LIGHTHOUSE PROJECT - Gadolinium Toxicity

shedding light on the effects of retained gadolinium from Contrast MRI

We started the Lighthouse Project to shed light on the effects of retained Gadolinium from Gadolinium-Based Contrast Agents (GBCAs) used for contrast-enhanced MRIs and MRAs.

This website is part of our effort to increase awareness of the effects of Gadolinium Toxicity.

GBCAs are generally thought to be safe to use in patients with good kidney function.

However, retention of Gadolinium is known to have serious consequences including the incurable and potentially life-threatening disease known as Nephrogenic Systemic Fibrosis or NSF.

Since we launched our website in 2014, there has been a significant amount of new research published that indicates that gadolinium is being deposited in the brain.

As a result of those findings, on July 27, 2015, the FDA released a new Safety Announcement regarding Gadolinium-Based Contrast Agents.

The FDA is investigating the risk of BRAIN DEPOSITS of gadolinium following repeated use of GBCAs for magnetic resonance imaging (MRI).

While GBCAs are being investigated, they can still be administered; however, health care professionals have been cautioned to limit GBCA use to circumstances in which the use of contrast is deemed necessary.

We created this website as a way to alert people to a problem that was not yet recognized by the FDA and medical industry. . . .
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Keebler
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. . . sense of an electrified, vibrating, twitching feeling typically just under the skin . . . .


https://gadoliniumtoxicity.com/help/symptoms/

LIGHTHOUSE PROJECT

SYMPTOMS associated with Gadolinium Toxicity

Excerpts:

. . . Symptoms

Some of the symptoms experienced fall outside normal descriptive terms for medical symptoms making it hard for patients to communicate to their doctors just what they are experiencing.

For those symptoms, we will provide additional descriptive details as appropriate.

In rough order of frequency as reported in our Survey of the Chronic Effects of Retained Gadolinium from Contrast MRIs,

Pain – aching; burning, tingling, and/or prickling pain (paresthesia); deep bone pain. Typically in extremities or joints, and sometimes in the location where the MRI occurred, like the head.

Dermal changes – like tight skin, lesions, hyperpigmentation. Most often in extremities.

Muscle issues – twitching – small, local, rapid contractions and weakness

Ocular problems – worsening vision, dry eyes, bloodshot eyes

Cognitive symptoms

Ear, nose and throat – tinnitus, swallowing, and voice problems

Low body temperature

Hair loss

Itchy skin

Balance problems

Swelling of extremities (edema)

There is one symptom experienced by many that transcends several of the symptoms listed above.

It is a sense of an electrified, vibrating, twitching feeling typically just under the skin that is sometimes localized and at other times a more overall feeling.

Sometimes it feels like something is crawling around under the skin.

This is a particularly alarming feeling when first experienced as it is unlike anything that the person has ever experienced and it is very difficult to explain to doctors. . . .

[Full entry at link above]


https://en.wikipedia.org/wiki/Nephrogenic_systemic_fibrosis

Nephrogenic systemic fibrosis [Wikipedia]

Excerpt:

Nephrogenic systemic fibrosis (NSF) or nephrogenic fibrosing dermopathy (NFD)[1] is a rare and serious syndrome that involves fibrosis of skin, joints, eyes, and internal organs.

The first cases were identified in 1997 and its cause is not fully understood.

However, evidence suggests NSF is associated with exposure to gadolinium (with gadolinium-based MRI contrast agents being frequently used as contrast agents for magnetic resonance imaging (MRI)) in patients with severe kidney failure.[2] . . . .
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[ 12-19-2017, 02:14 PM: Message edited by: Keebler ]

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Keebler
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An aside: If one is taking ibuprofen at the time such contrast agent might be administered (or even later?), it would seem to me that it might exasperate the issues with this agent not being able to "move out" of the body because:

Ibuprofen constricts blood flow. This can pose problems.

http://kidney.niddk.nih.gov/kudiseases/pubs/analgesicnephropathy/

National Kidney & Urulogic Diseases Information Clearinghouse (NKUDIC)

Analgesic Nephropathy (Painkillers and the Kidneys)

Excerpts:

. . . Analgesic use has been associated with two different forms of kidney damage: acute renal failure and a type of chronic kidney disease called analgesic nephropathy. . . .

. . . Some patient case reports have attributed incidents of sudden-onset acute kidney failure to the use of over-the-counter painkillers, including aspirin, ibuprofen, and naproxen sodium. . . .

. . . A second form of kidney damage, called analgesic nephropathy, can result from taking painkillers every day for several years. . . . .

. . . Ibuprofen may also increase the risk of chronic kidney damage, . . .


http://www.nytimes.com/1990/04/16/us/kidney-peril-found-in-the-pain-reliever-ibuprofen.html

Kidney Peril Found in the Pain Reliever Ibuprofen

(AP) April 16, 1990 – The New York Times

Excerpts:

The popular pain reliever ibuprofen can cause kidney failure in people with mild kidney disease, according to a new study.

A three-year study on the drug was reported today in the journal Annals of Internal Medicine. . . .

. . . gave participants above-normal doses of 800 milligrams of ibuprofen three times a day - the equivalent of 12 ibuprofen tablets - for up to 11 days.

After eight days, three women developed kidney failure, which reversed when ibuprofen was discontinued. The remaining nine women, who received ibuprofen for 11 days, showed changes in kidney function but did not develop kidney failure.

After recovering, the three women were given 400 milligrams of ibuprofen three times a day, equivalent to normal doses of the drug.

Two of the three again developed kidney failure but recovered when the ibuprofen was stopped.

Ibuprofen relieves pain by interfering with the body's production of prostaglandin, a substance involved in inflammation. But at the same time, the drug constricts blood flow.

Normally, the change poses little risk if used for a short period.

But for those whose blood flow to the kidneys is already reduced by kidney, heart or liver damage, flu, or aging, ibuprofen could lead to acute kidney failure. . . .

- Full article at link above.
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Lymetoo
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Thanks for the info, Keeb.

--------------------
--Lymetutu--
Opinions, not medical advice!

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aklnwlf
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Great info. Alarming though because I've had many, many MRI's over the years. Anyway to detox this stuff out of the body?

--------------------
Do not take this as medical advice. This comment is based on opinion and personal experience only.

Alaska Lone Wolf

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Keebler
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Follow the links here for treatment / help:

https://gadoliniumtoxicity.com/

LIGHTHOUSE PROJECT - Gadolinium Toxicity


As some of those things on their list, such as chelation tx might not be available, there are still likely other ways to approach, too. Naturopathic doctors likely will know more.

While I've not crossed searched and so far in my research of the past couple days immersed with her work, she might have some ideas.

I'm learning lots about Vitamin C from videos at YouTube and her own facebook page. I finally found out about a non-acidic vitamin C. I'd been avoiding due to the acid. And buffered ones are not good.

Vit. C is so good for helping the body move out toxins and heal. It's worth turning all attention for a while to just study her work

Search at Google and YouTube and Facebook for: Dr. Suzanne Humphries

Then, cross search her name in " " with whatever terms you choose.
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aklnwlf
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Will do!

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Do not take this as medical advice. This comment is based on opinion and personal experience only.

Alaska Lone Wolf

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Rumigirl
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Keebler,

Thank you for your research on this!! I have had waaay too many MRI's, and other tests, with contrast!!! Especially last year. I have been concerned about this for a while.

Please keep us apprised of what you find out, esp in terms of treatment to eliminate it. Sigh. There are so many darned things to deal with.

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Keebler
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Rumigirl,

Since I have not had this contrast agent myself, I do not intend to look further into this. If I stumble upon something I will post it, though. A lot of important articles I just stumble upon. I have other priorities to learn about for my own body.

Right now, I'm studying all I can of the work of Suzanne Humphries, MD in regard to Vitamin C.
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