Gadolinium Toxicity

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July 21, 2017 – European Medical Authority takes action on Linear Contrast Agents.  Read all about it.

March 10, 2017 – European group recommends to stop using 4 linear GBCAs Read all about it.

February 27, 2017 – New Study Reports Gadolinium Retention in 70 Cases with Normal Kidney Function. Read all about it.

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The viewpoints presented here include Gadolinium Toxicity news and thoughts about various aspects of living with the effects of Gadolinium Toxicity.  They may just be one person’s idea or an experience that happened to them.  These viewpoints are important to share, because someone looking at them from a different viewpoint may be able to tie some things together in a way that we did not see.

Television Coverage of Gadolinium Toxicity on Full Measure

Sharyl Attkisson, five-time Emmy Award winner, and recipient of the Edward R. Murrow investigative reporting award, featured Gadolinium Toxicity in her June 11 edition of Full Measure.  Chuck Norris and his wife Gena Norris both talked about her struggle with her related symptoms that resulted in them spending over $1,000,000 on special care.

Our own Sharon Williams was also featured in the segment, both for her own symptoms and for her advocacy including letters to the FDA in starting in 2012 and the maintenance of this website..

Y0u can see a video of the program and read the dialogue here:
http://fullmeasure.news/news/cover-story/mri-06-11-2017

European Medicines Agency takes action on Linear Gadolinium-based Contrast Agents

On July 21, 2017, the European Medicines Agency (EMA) confirmed previous recommendations to suspend the use of three linear gadolinium-based contrast agents (GBCAs) used for MRIs, citing potential risks from brain deposition of gadolinium.  The use of one other linear GBCA will be restricted to liver scans.

The 3 suspended agents are Magnevist (gadopentetic acid), Omniscan (gadodiamide), and OptiMark (gadoversetamide).  The agent restricted to liver scans is MultiHance (gadobenic acid).

Read the article on Aunt Minne about this action here:
http://www.auntminnie.com/index.aspx?sec=ser&sub=def&pag=dis&ItemID=117859

The official announcement from the EMA can be found here:
http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/gadolinium_contrast_agents_31/Opinion_provided_by_Committee_for_Medicinal_Products_for_Human_Use/WC500231824.pdf

Additional information on the EMA website can be found here:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Gadolinium-containing_contrast_agents/human_referral_prac_000056.jsp&mid=WC0b01ac05805c516f

We are encouraged by the EMA’s action and believe that the FDA should take a similar stance.

Patients and their doctors should report all adverse events and clinical symptoms to the FDA or the appropriate governing authority in their country.  Chronic symptoms that develop soon after MRIs with contrast could be manifestations of the harm done by gadolinium deposition in the brain, bones, and elsewhere in the body.

Open Letter to the FDA about Gadolinium-based Contrast Agents

Editorial – May 25, 2017
Sharon Williams

I am very disappointed and frustrated by the May 22, 2017, FDA Safety Announcement about gadolinium-based contrast agents (GBCAs).  I am beginning to wonder how many more people must be adversely affected by retained gadolinium before the FDA decides to take decisive action.

Personally, I don’t blame the FDA or radiologists for what happened to NSF patients.  What happened to those patients was terrible, but I want to believe that no one knew then just how unstable the linear agents are, especially when they remain in the body for longer periods of time like they might do in renally-impaired patients.  However, once the connection between NSF and GBCAs was discovered in 2006, that all began to change.  No longer could the FDA and radiology community say that they didn’t know that gadolinium might be retained from MRI contrast agents or what it might do to the human body when that occurred.

From 2006 until the end of 2013, the FDA and medical community thought that only patients with severe renal problems were at risk of retaining gadolinium.  Warnings were issued and action was taken to better screen renally-impaired patients and reports of new cases of Nephrogenic Systemic Fibrosis (NSF) dropped dramatically.  However, no one seemed to be investigating what might happen when less gadolinium was retained such as what might occur in patients with “normal” renal function or eGFRs greater than 60.

Since December of 2013 and the first paper by Kanda and his colleagues, the evidence has been mounting that clearly shows that patients with normal renal function retain gadolinium in their brains, bones, and elsewhere in their bodies. This seemed to be news to the FDA and radiology community, but it was something that patients affected by gadolinium have long been trying to tell their doctors.  I first brought it to the attention of the FDA in my letter of October 23, 2012.  In that letter, I noted that evidence of gadolinium retention in patients with normal renal function was reported by Gibby et al. in 2004 – that was 13 years ago, and it occurred after administration of both a linear and a macrocyclic GBCA.

The published literature clearly states that “gadolinium is toxic”.  The FDA has acknowledged that “all GBCAs may be associated with some gadolinium retention in the brain, and other body tissues”.  So why is it okay to keep injecting the least stable gadolinium-based contrast agents into patients when it is highly likely that those people are going to retain some unknown amount of a toxic metal?  Gadolinium is a toxic metal that has been found to be neurotoxic, to impair mitochondrial function, induce oxidative stress, and much more.  Researchers are looking for histological changes in the brain, but what about functional changes? (more…)

FDA indicates no effects found yet from retained gadolinium in the brain

On Monday, May 22, 2017, the FDA issued its second Safety Announcement about gadolinium retention in the brain. The following text is the FDA’s complete announcement.

FDA Drug Safety Communication: FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue

This is an update to the FDA Drug Safety Communication: FDA evaluating the risk of brain deposits with repeated use of gadolinium-based contrast agents for magnetic resonance imaging (MRI)issued on July 27, 2015.

Safety Announcement

[ 5-22-2017]

A U.S. Food and Drug Administration (FDA) review to date has not identified adverse health effects from gadolinium retained in the brain after the use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). All GBCAs may be associated with some gadolinium retention in the brain and other body tissues. However, because we identified no evidence to date that gadolinium retention in the brain from any of the GBCAs, including GBCAs associated with higher retention of gadolinium, is harmful, restricting GBCA use is not warranted at this time. We will continue to assess the safety of GBCAs and plan to have a public meeting to discuss this issue in the future.

Our recommendations for health care professionals and patients remain unchanged from July 2015 when we informed the public that we were investigating this potential risk with GBCAs. As is appropriate when considering the use of any medical imaging agent, health care professionals should limit GBCA use to circumstances in which additional information provided by the contrast agent is necessary, and assess the necessity of repetitive MRIs with GBCAs. Patients, parents, and caregivers should talk to their health care professionals if they have any questions or concerns about the use of GBCAs with MRIs. Retention of gadolinium affects only GBCAs, and does not apply to other types of scanning agents used for other imaging procedures, such as those that are iodine-based or radioisotopes.

GBCAs contain gadolinium, a type of heavy metal, that is linked to a carrier molecule. MRIs are a way to scan the body for problems such as cancer, infections, or bleeding. GBCAs are injected into a vein to enhance the quality of the MRI images of internal organs, blood vessels, and tissues, which helps health care professionals diagnose medical conditions. There are two types of GBCAs based on their chemical structures, linear GBCAs and macrocyclic GBCAs.

We evaluated scientific publications1-17 and adverse event reports submitted to FDA. Some human and animal studies looked at GBCA use over periods longer than a year. These publications and reports show that gadolinium is retained in organs such as the brain, bones, and skin. The publications show that linear GBCAs retain more gadolinium in the brain than macrocyclic GBCAs. However, our review did not identify adverse health effects related to this brain retention.

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. NSF is a painful skin disease characterized by thickening of the skin, which can involve the joints and cause significant limitation of motion within weeks to months. Recent publications report cases of reactions involving thickening and hardening of the skin and other tissues in patients with normal kidney function who received GBCAs and did not have NSF; some of these patients also had evidence of gadolinium retention.3, 12, 16 We are continuing to evaluate such reports to determine if these fibrotic reactions are an adverse health effect of retained gadolinium.

The manufacturer of OptiMARK (gadoversetamide), a linear GBCA, updated its label with information about gadolinium retention in various body organs such as the brain, skin, and other organs. We are reviewing the labels of other GBCAs to determine if changes are needed.

A recent review by the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) also identified no adverse health effects with gadolinium retention in the brain, but that Committee recommended suspending the marketing authorization of certain linear GBCAs because they cause a greater retention of gadolinium in the brain compared to macrocyclic GBCAs. The Committee’s recommendation is currently undergoing an appeal, which will be further reviewed by the PRAC and subsequently by the EMA’s Committee for Medicinal Products for Human Use.18

We are continuing to assess the safety of GBCAs. FDA’s National Center for Toxicological Research (NCTR) is conducting a study on brain retention of GBCAs in rats. Other research is also being conducted about how gadolinium is retained in the body. We will update the public when new information becomes available and we plan to have a public meeting to discuss this issue in the future.

We urge patients and health care professionals to report side effects involving GBCAs or other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

The list of approved GBCAs and References included with this FDA Communication can be found here: https://www.fda.gov/Drugs/DrugSafety/ucm559007.htm

The link to MedWatch can be found on the Contact FDA page.
https://www.fda.gov/AboutFDA/ContactFDA/default.htm

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