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A recent review article by Ramalho et al summarizes the literature on gadolinium-based contrast agents or GBCAs that are administered for contrast-enhanced MRIs, and it ties together information on agent stability, and animal and human studies. The article, “Gadolinium-Based Contrast Agent Accumulation and Toxicity: An Update”, also emphasizes that the low-stability agents are the ones most often associated with brain deposition of gadolinium that has been reported in the literature since 2014.
Since the article has Open Access at AJNR.org, I will not go into all of the details of it. However, there are some facts contained in the paper that I want to present here that are relevant to why GadoliniumToxicity.com exists. In 2014, Hubbs Grimm and I created this website as a way to alert people to a problem that was not yet recognized by the FDA and medical industry. That problem was gadolinium retention in patients with normal renal function. We knew the facts were in the published literature, but they just had not been seen by the right people yet. Thankfully, that has now begun to change.
Nephrogenic Systemic Fibrosis (NSF)
No review of GBCAs would be complete without some background information on NSF.
In 2006, the association between the administration of GBCAs and the development of Nephrogenic Systemic Fibrosis (NSF) in patients with severe renal disease was reported by Grobner and then by Marckmann et al. NSF predominantly involves the skin, but it is a systemic disease that may also affect other organs such as the lungs, liver, heart, and muscles. The exact pathophysiology of NSF remains unknown, but as the review states, the dissociation of gadolinium ions from their chelating ligands has been accepted as the primary etiology. That is more likely to occur in patients with renal failure than in those with normal renal function since the excretion rate is reduced in those with renal failure. The article indicates that most cases of NSF reported in the literature have been associated with the administration of nonionic, linear gadodiamide (Omniscan, GE Healthcare), nonionic, linear gadoversetamide (OptiMARK, Covidien), and with ionic, linear gadopentetate dimeglumine (Magnevist, Bayer HealthCare Pharmaceuticals).
After limiting the use of GBCAs in patients with renal failure and using more stable GBCAs, there have been no new cases of NSF reported since mid-2009. According to the paper, from 2009 to 2014, confidence in the safety of GBCAs had been largely restored. However, since 2014, numerous studies have been published that reported finding evidence of gadolinium deposition in neural tissues in patients with normal renal function. (more…)
We have some important news to share with patients with normal or near normal renal function who have developed unexplained symptoms since their exposure to gadolinium-based contrast agents (GBCAs). The disease we have been dealing with now has a name: Gadolinium Deposition Disease or GDD.
UNC Radiologist, Richard Semelka, MD, has given us permission to publish his “Initial Draft” of the Disease Description for Gadolinium Deposition Disease on our website; to our knowledge, this is the first time it has been published. Dr. Semelka said that this statement is a work in progress, and he intends to revise and expand it as he learns more about patterns of the disease. If important changes are needed, a revised Disease Description will be published.
While his research is ongoing, Dr. Semelka felt that it was important to release the Disease Description now, so that GDD is recognized as an entity by an expert, which he believes should be very important for sufferers. Dr. Semelka wants to get the initial description of the disease out into the community to start to provide relief and benefit to patients affected by retained gadolinium.
Gadolinium Deposition Disease. Disease Description.
Author: Richard C Semelka, MD. November/2015
Gadolinium Deposition Disease (GDD) is a disease process observed in subjects with normal or near normal renal function who develop persistent symptoms that arise within hours to 2 months following the administration of gadolinium based contrast agents (GBCAs). In these cases, no pre-existent disease, or subsequently developed disease of an alternate known disease process, is present to account for the symptomatology.
Patient symptoms are similar but not identical to those observed in the condition Nephrogenic Systemic Fibrosis (NSF). Typical clinical features include persistent headache and bone and joint pain. More distinctive features are comparable to those observed in NSF, but to a lesser extent; patients often experience subcutaneous soft tissue thickening that clinically appears somewhat spongey, without the hardness and redness observed in NSF. Tendons and ligaments in a comparable distribution may also appear thickened and painful. Patients may complain of a tightness of the hands and feet that resemble the feeling of being fitted with extremely tight gloves or socks. Patients may experience excruciating pain typically in a distal distribution of the arms and legs but may also be torso or generalized in location. This pain is often described as ‘cutting’ or ‘burning’.
Supporting laboratory evidence.
In the early months following development of the disease patients should exhibit elevated blood, urine or other tissue gadolinium levels. The exact levels necessary are not yet determined. Bone gadolinium deposition is likely present for many years following disease development. In the early months after disease development, it may be of value to show elevated gadolinium deposition in some fluid or tissue to establish the diagnosis.
As affected patients ourselves, we want to thank Dr. Semelka for publicly recognizing that patients with normal renal function are retaining gadolinium from administered GBCAs, and that they are being adversely affected by its toxic effects.
Sharon Williams and Hubbs Grimm
You can learn more about Dr. Semelka at: https://www.med.unc.edu/radiology/Dept-info/faculty-staff/faculty-pages/richard-semelka-m-d
Dr. Semelka co-authored a recently published study by Ramalho et al, High Signal Intensity in Globus Pallidus and Dentate Nucleus on Unenhanced T1-weighted MR Images: Evaluation of Two Linear Gadolinium-based Contrast Agents.
Editorial – I believe the FDA needs to do more to regulate the use of linear and macrocyclic gadolinium-based contrast agents administered for enhanced MRIs and MRAs.
Since January 2014, I am aware of nine studies that have reported finding evidence of gadolinium deposition within the brain tissues of patients exposed to gadolinium-based contrast agents or GBCAs. In most of those studies, the patients did not have severe renal disease, in fact, most were described as having “normal renal function” or an eGFR >60. Despite the increasing number of new studies that indicate that gadolinium is remaining in the brain, some still question whether there is any clinical significance. Speaking as someone who has been adversely affected by retained gadolinium, I believe that there is clinical significance, and I am not alone. Members of our MRI-Gadolinium-Toxicity support group have reported symptoms that are consistent with what is known about the toxic effects of gadolinium. Since we released the results of our 2014 Survey of the Chronic Effects of Retained Gadolinium from Contrast MRIs, our support group has almost tripled in size and another affected patient recently started a group on Facebook. I believe the problems related to gadolinium retention are significant, but they are not being recognized. (more…)
An Editorial – On April 8, 2015, I received the results from testing of my thyroid tissue for gadolinium. As I expected, gadolinium (Gd) was found. I do not know if the results will ever be published anywhere, but I felt that it was important that I share this information with other affected patients, as well as with any physicians and researchers who might visit our website.
Due to personal concerns, I won’t share the amount of gadolinium found in my tissue here. However, the published researcher who did the testing said, “The concentration of Gd in the tissue is significantly elevated relative to normal ‘background’ tissues”. “Based on the simultaneous analysis of other rare earth elements, it is clear that this does reflect Gd from a unique Gd-rich source consistent with Gd-based contrast agents.” Part of my thyroid gland was removed in June of 2014 – 51 months after my 5th dose of a gadolinium-based contrast agent. (more…)