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MRI contrast warning.......

Discussion in 'Educating Doctors' started by Jack Kruse, Jan 22, 2018.

  1. Jack Kruse

    Jack Kruse Administrator

    SOURCE: FDA MedWatch
    ISSUE: FDA is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in patients' bodies, including the brain, for months to years after receiving these drugs. Gadolinium retention has not been directly linked to adverse health effects in patients with normal kidney function, and FDA has concluded that the benefit of all approved GBCAs continues to outweigh any potential risks. However, after additional review and consultation with the Medical Imaging Drugs Advisory Committee, FDA is requiring several actions to alert health care professionals and patients about gadolinium retention after an MRI using a GBCA, and actions that can help minimize problems. These include requiring a new patient Medication Guide, providing educational information that every patient will be asked to read before receiving a GBCA. FDA is also requiring manufacturers of GBCAs to conduct human and animal studies to further assess the safety of these contrast agents. To date, the only known adverse health effect related to gadolinium retention is a rare condition called nephrogenic systemic fibrosis (NSF) that occurs in a small subgroup of patients with pre-existing kidney failure. FDA received reports of adverse events involving multiple organ systems in patients with normal kidney function. A causal association between these adverse events and gadolinium retention could not be established.

    BACKGROUND: This is an update to the May 22, 2017 MedWatch safety alert "Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - No Harmful Effects Identified With Brain Retention".

    GBCAs are used with medical imaging devices called MRI scanners to examine the body for problems such as cancer, infections, or bleeding. GBCAs contain gadolinium, a heavy metal. These contrast agents are injected into a vein to improve visualization of internal organs, blood vessels, and tissues during an MRI, which helps health care professionals diagnose medical conditions. After being administered, GBCAs are mostly eliminated from the body through the kidneys. However, trace amounts of gadolinium may stay in the body long-term. Many GBCAs have been on the market for more than a decade.

    There are two types of GBCAs based on their chemical structures: linear and macrocyclic (see Table 1 in Drug Safety Communication). Linear GBCAs result in more retention and retention for a longer time than macrocyclic GBCAs. Gadolinium levels remaining in the body are higher after administration of Omniscan (gadodiamide) or OptiMARK (gadoversetamide) than after Eovist (gadoxetate disodium), Magnevist (gadopentetate dimeglumine), or MultiHance (gadobenate dimeglumine). Gadolinium levels in the body are lowest after administration of Dotarem (gadoterate meglumine), Gadavist (gadobutrol), and ProHance (gadoteridol); the gadolinium levels are also similar across these agents.

    RECOMMENDATION: Health care professionals should consider the retention characteristics of each agent when choosing a GBCA for patients who may be at higher risk for gadolinium retention (see Table 1 listing GBCAs). These patients include those requiring multiple lifetime doses, pregnant women, children, and patients with inflammatory conditions. Minimize repeated GBCA imaging studies when possible, particularly closely spaced MRI studies. However, do not avoid or defer necessary GBCA MRI scans.

    Patients, parents, and caregivers should carefully read the new patient Medication Guide that will be given to you before receiving a GBCA. The Medication Guide explains the risks associated with GBCAs. Also tell your health care professional about all your medical conditions, including:
    • If you are pregnant or think you might be pregnant
    • The date of your last MRI with gadolinium and if you have had repeat scans with gadolinium
    • If you have kidney problems
    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
    • Complete and submit the report Online: www.fda.gov/MedWatch/report
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
    Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication by clicking here.
  2. Mito1

    Mito1 New Member

    states there's a concern then later in the article states nothing is wrong - usual double talk with any gov agency.
    JanSz likes this.
  3. Josh Rosenthal

    Josh Rosenthal Charter member of Purple Angels Club

    metal in the body and EMF no bueno i guess... =]
    WillTheHammer likes this.
  4. Jack Kruse

    Jack Kruse Administrator

    yep......I learned this the hard way.
    Lahelada likes this.
  5. Jack Kruse

    Jack Kruse Administrator

    Despite the FDA black box label in 2007 and warning in 2015, practitioners continue to order these scans routinely without informing patients of the risks. The black box warning is for nephrogenic systemic fibrosis (NSF), a serious and sometimes fatal kidney condition, and anyone with kidney impairment is at risk. Gadolinium is normally excreted by the body through the kidneys, but kidneys functioning less than optimally have trouble getting rid of all of the gadolinium, so toxic levels build up in the body’s tissues and organs, including the brain.

    The FDA warning that came in 2015 was the one gadolinium toxicity advocates were fighting for. It reported what they knew all along – even people with normal kidney function can accumulate gadolinium in their bones and vital organs.

    What You Need To Watch For
    Most symptoms of gadolinium toxicity mimic the chronic conditions many people get imaging for, but there’s one that sets it apart. People describe it as a feeling of being electrified just underneath the skin, and some people experience it as feeling like their skin is crawling. Other symptoms include joint pains, muscle twitches, and cognitive changes which usually start within the first month after the exposure. Also common are itchy skin, deep bone pain close to the site of the MRI, numbness or tingling, dry eyes, tinnitus (ringing in the ears), hair loss, balance problems and swelling in feet and hands.
  6. Jack Kruse

    Jack Kruse Administrator

  7. Billybats

    Billybats New Member

    Is this only the contrast for MRI. What about CAT scans. I looked into gadolinium and the iodine contrast during my near death experience (not sure if gadolinium is in it) when I had my CAT scan done at the time is when I felt like my body was shutting down. Very scary.. I was on antibiotics and following the dumb Ray Peat crap (sorry for my bitterness) while doing other things I shouldn't have and going through menopause too, major whammies for my body. I had trouble peeing, vomiting, itchy, hives, headache, also had hyperthyroid/hypothroid fluctuations, major joint pain, and all sorts of other problems, waaayy to many to list. It was like my body didn't know what to do. As I researched my symptoms out of desperation it all boiled down the weirdest thing that my body was low and high of all vitamins and minerals. Bottomline I came up with was my HIP axis was totally screwed up. I was living on progesterone cream and supplements, maybe at that time they helped but not until I came here. Thank you sooooooo much. Mind you when all that happened it took 3-4 years to heal somewhat but I only been following Doc this August will be a year and I have stopped all supplements and doing pretty dam good for what I went through. XOXO to all.
    Dean6789, Jude and Alex97232 like this.
  8. Jenifer Caplan

    Jenifer Caplan I am the outlier

    Did you have GD when you had an mri! I was poisoned in feb this year I just started hyperbaric oxygen therapy for my brain burning and i had chelation therapy. You can get a heavy metals test from Dr Data to see if you have the GD still in your body. The GD interferes with cellular function and so yiu have to get those mitochondria to really start working better in order to heal. I started drinking DDW eating oysters going on the sun and doing red light therapy on my head .. after 5 months of feeling like I was dying I had a good day last week. Will continue to do everything as now it’s a lifestyle change and its all good for me exercise I will stop hyperbaric Oxygen in a few sessions
    Alex97232 and karenr like this.
  9. Jenifer Caplan

    Jenifer Caplan I am the outlier

    This is why i am sick. Hoping you have more insight to help this specific issue. Thank you for bringing it to the attention of your members...
  10. Jack Kruse

    Jack Kruse Administrator

    The key is raising your redox via light water and magnetism.
    Dean6789 likes this.
  11. Jenifer Caplan

    Jenifer Caplan I am the outlier

    I’m trying... I’m outside now drinking DDW and getting sun.. and praying to heal..wish I could get less expensive DDW.
    Dean6789 and Jack Kruse like this.
  12. Billybats

    Billybats New Member

    I didn't have an MRI but did have CAT scan. My improvement started with working on the redox. I also noticed while I was doing this any supplement messed up the process. So just do what you been doing with Dr. K advises Sun, water, and magnetism. It will take time. So far since I left Vermont I only missed 1 morning Sun, before i wasn't consistent with it. I definitely do oysters as much as I can too. It took more time to heal without the sun and using supplements. It has been less then a year and I have seen big improvements. I am guessing the body goes in cycles of fixing itself and if it does I feel somedays awesome and some days just okay but its all good compared to before.
    Alex97232 likes this.
  13. JanSz

    JanSz Gold

    Lawyers already know about
    gadolinium toxicity.

    I see ads on TV.
    Promising big $$ to those who are injured.

    / upload_2018-6-12_10-48-32.png
    Last edited: Jun 12, 2018
    Dean6789, Mayuri and Sajid Mahmood like this.
  14. Jack Kruse

    Jack Kruse Administrator

    Those cycles are based on the solar cycles.....more time at equatorial environment = faster reversal
  15. Billybats

    Billybats New Member

    Really?.. but from what you talk about I understand why and the more I read the more comes to me. I'll tell you Doc listening to your talk at Vermont it was like you were behind me and smacked my head..yeah see..

    Video below is Doc K and Us.. except its rule number 1..

  16. Jenifer Caplan

    Jenifer Caplan I am the outlier

    They are just now trying to do class action , that means money for them and non for the suffers. The first lawsuit was filed a few days ago for an individual in following that case to see how it plays out
    KrusinWitchie likes this.
  17. nonchalant

    nonchalant Silver

    I agree, Billybats. I saw different improvements with the various protocols, but my bun/creat ratio didn't improve much until I ditched the supps (except for MB).
    Mayuri likes this.
  18. Jenifer Caplan

    Jenifer Caplan I am the outlier

    What is MB.. methylenble? Can u let me know how you used it.. I got some but I am a bit lost on the protocol. Any advice thank u
  19. Lahelada

    Lahelada New Member

    MB +methylene blue
  20. Jenifer Caplan

    Jenifer Caplan I am the outlier

    Yes and can I let me know how you used it?

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