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A new study by Alwasiyah et al. concluded that the current reference range of 0.7 μg/24hr for 24-hour urinary gadolinium is not applicable to patients for at least 30 days following exposure to a gadolinium-based contrast agent (GBCA). In the study, the authors “calculated an estimated average of 57 days for the urinary gadolinium to creatinine ratio to reach below the current reference range following GBCA exposure and possibly much longer (i.e., 80+ days)”. The article, “Urinary Gadolinium Levels After Contrast-Enhanced MRI in Individuals with Normal Renal Function: a Pilot Study”, was published online December 12, 2018 in the Journal of Medical Toxicology.
This was a prospective, observational pilot study to determine urine gadolinium concentrations over a 30-day period after GBCA administration in patients with normal renal function. The 13 subjects were between 18 and 65 years of age and were reported to have received a gadolinium-based contrast agent for the first time. Prior to contrast administration, spot urine samples were obtained and tested for gadolinium and creatinine. All testing was performed by Mayo Medical Laboratories in Rochester, MN. Post-MRI 24-hour urine testing was performed on day 3, 10 and 30. Eight subjects received gadobutrol (Gadavist®), four received gadopentetate dimeglumine (Magnevist®), and 1 received gadoxetate disodium (Eovist®) for their MRIs with contrast. The authors reported that all 13 subjects had 24-hour gadolinium levels higher than 0.7 μg/24hr on day 3, day 10, and day 30 after contrast administration. The authors estimated that “urinary gadolinium levels will often remain above the current reference range for >50 days”. (more…)
Study Reports Gadolinium Clearance Times for 135 Contrast MRI Cases including Agent Administered for 63 Unconfounded Cases
On December 5, 2018, Hubbs Grimm and Sharon Williams, coauthors of GadoliniumToxicity.com, released their fifth research paper on gadolinium retention from Gadolinium-based Contrast Agents (GBCAs) administered for contrast-enhanced MRIs. The paper is titled Gadolinium Clearance Times for 135 Contrast MRI Cases and includes the contrast agents for the unconfounded cases.
Drawing on the contrast MRI history and 24-hour gadolinium urine testing results that have been received from members of the MRI-Gadolinium-Toxicity Support Group, the study reports retrospectively on 135 cases with 218 urine test results, including 63 unconfounded cases with 81 test results. The participants all had normal kidney function and report having symptoms of gadolinium toxicity. The results reported are dramatic and involve all linear and macrocyclic GBCAs currently in use in the United States.
About the Gadolinium Clearance Time Report
In addition to reporting on additional cases received since our previous paper in 2017, we now report the contrast agents received with each unconfounded case. Analysis of the these cases produced trend lines over time that indicate typical gadolinium found in 24-hour urine testing for each of the agents including Dotarem, Gadavist, Magnevist, MultiHance, Omniscan, OptiMARK, and ProHance. The graphs and tables provide helpful information for both patients and medical practitioners trying to understand their test results. The analysis of clearance times for each agent is presented on a separate page.
The results show that all agents, both linear and macrocyclic, do not clear from the body in a few days as most patients are told. None of the test results in the first 2.5 months following a contrast-enhanced MRI was within the reference range used by Mayo Clinic Laboratories. It should be noted that the contrast agent and test result information presented is from people who believe they are suffering symptoms of gadolinium toxicity since their contrast-enhanced MRI. It is not known whether the clearance times presented would also apply to individuals who are not symptomatic.
The complete set of test results, without any data that would identify patients, is available to other researchers upon request.
With the evidence provided that clearance times are much longer for all of the agents than expected by medical practitioners, the authors present five recommendations for needed actions by medical professionals, other researchers, government agencies, and contrast agent manufacturers.
We want to thank members of the MRI-Gadolinium-Toxicity Support Group for their willingness to share their test results and other information with us. Our papers would not be possible without their continued support.
We urge patients, clinicians, and researchers to read the entire report and share as appropriate with your families, caregivers, and colleagues.
Hubbs Grimm and Sharon Williams
Editorial by Sharon Williams
What difference does a name make? Evidently, when you are naming a disease it can make a huge difference. The name can limit the scope of medical research, and when it comes to gadolinium, it has the potential to exclude other patient populations who have been exposed to the same toxic metal.
In 1997, when a group of patients on dialysis developed what appeared to be a new skin disorder, it was called Nephrogenic Fibrosing Dermopathy (NFD). When researchers later learned that the problem went well beyond the patients’ skin and caused a systemic disease process, the name was changed to Nephrogenic Systemic Fibrosis (NSF). The word “nephrogenic” in the name caused doctors and researchers to focus on people with severe renal disease. At the beginning, that made sense since the problem only had been seen in patients with end-stage renal disease (ESRD). Later we learned more about the cause.
In 2006, nine years after NSF/NFD was first diagnosed, the connection was made between NSF and gadolinium-based contrast agents (GBCAs) administered for MRIs. Even though impaired kidney function did not cause NSF, the focus remained on the “N” or nephrogenic part of NSF. Patients with normal kidney function were being overlooked; however, they were not unaffected by retained gadolinium from GBCAs.
On December 19, 2017, the FDA issued a new Safety Announcement related to gadolinium-based contrast agents (GBCAs) administered for MRIs. One of the actions described in the announcement was the requirement that every patient be given a Medication Guide to read before receiving a GBCA. The Medication Guides for all GBCAs are now available. However, on May 16, 2018, the FDA issued an Update to the requirement that patients be given the Medication Guides prior to their MRIs.
It appears that the FDA has determined that, “hospital inpatients are not required to receive a Medication Guide unless the patient or caregiver requests it”.
Since most people are not aware that patients are retaining gadolinium from GBCAs administered for MRIs or that gadolinium is a toxic metal, they will not know to ask for a copy of the Medication Guide or that one even exists. That will result in a vulnerable population of patients not being fully-informed about the potential risk of gadolinium deposition in their brain, bones, skin, and other tissues.
As documented in the medical literature, patients in hospitals are at greater risk of having an acute kidney injury or AKI which can impair patients’ kidney function and potentially cause them to retain more gadolinium. I believe that patients in hospitals and/or their families should be informed about that risk and they should be given a Medication Guide for the GBCA that will be administered for any inpatient imaging procedures.
The following is the FDA’s May 16, 2018 Update – (more…)