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On December 19, 2017, the FDA issued an update to its Drug Safety Communication regarding brain retention of gadolinium-based contrast agents (GBCAs) used for MRIs. Despite mounting evidence that GBCAs leave gadolinium in the brain, bones, and other tissues of all patients who undergo MRIs with contrast, the FDA has decided not to suspend the use of any GBCAs. This is in stark contrast to the actions taken by the European Medicine’s Agency and the U.K.’s Medicines and Healthcare Products Regulatory Agency. Those agencies suspended the use of the linear agents Magnevist, Omniscan, and OptiMark, while requiring changes to all GBCA product labeling. The Japanese Ministry of Health, Labour and Welfare restricted the use of non-specific linear GBCAs only to cases where there is no alternative and it also required changes to product labeling.
In its Safety Alert, the FDA acknowledged that “linear GBCAs result in more retention and retention for a longer time than macrocyclic GBCAs”. However, the FDA concluded that “the benefit of all approved GBCAs continues to outweigh any potential risks”. This action was taken despite “reports of adverse events involving multiple organ systems in patients with normal kidney function”.
In response to the issue of gadolinium retention, the FDA is requiring several actions to alert health care professionals and patients about gadolinium retention after an MRI using a GBCA. These include requiring a new patient Medication Guide for each agent, providing educational information that every patient will be asked to read before receiving a GBCA, and taking actions that can help minimize problems. The FDA is also requiring manufacturers of GBCAs to conduct human and animal studies to further assess the safety of gadolinium-based contrast agents. Product labeling for all GBCAs must be changed to include new warnings and precautions.
Each GBCA will have a patient Medication Guide with agent specific information, and content that is required for all gadolinium-based contrast agents; the Medication Guide for MultiHance and ProHance have recently been released. The Radiology Department of each institution will create educational handouts that every patient will be asked to read before signing the consent form for his or her MRI or MRA with a GBCA.
Patients must be fully-informed about potential risks. (more…)
On November 1, 2017, Chuck and Gena Norris filed a lawsuit against 11 companies involved in the manufacture and distribution of two gadolinium-based contrast agents (GBCAs). The $10 million lawsuit was filed in San Francisco County Superior Court by Todd Walburg of Cutter Law. While it is not the only lawsuit that has been filed recently against MRI contrast agent manufacturers, it is the first high-profile case.
Chuck and Gena Norris have brought much needed media attention to the issue of gadolinium retention from contrast-enhanced MRIs. We hope the media will continue to investigate the problems involving gadolinium-based contrast agents. We believe that Gena’s case is just the tip of the iceberg when it comes to gadolinium toxicity from GBCAs.
We anticipate that there will be ongoing media coverage of this story and that readers will get the most up-to-date information by doing a search of the Internet.
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 – Last December, I posted a Viewpoint titled “Gadolinium Retention – Is it all in my head?” When I wrote that, I believed I had retained gadolinium in my brain, thyroid gland, and various other parts of my body. I believed it, but I did not know it for sure. It is one thing to think it, but it causes totally different feelings when you have confirmation that you have retained a toxic metal in your body.
On April 8, 2015, I posted about the gadolinium found in my thyroid tissue that was removed 51 months after my 5th dose of a linear gadolinium-based contrast agent. In July, I learned that an analysis of my 2012 non-contrast brain MRI found evidence of gadolinium deposition in the globus pallidus; that MRI was performed exactly two years after my last dose of contrast. Because of recently published studies, I was not surprised that they detected residual gadolinium in my brain. At the time of my MRIs, except for hypertension and a past history of migraine headaches, I had no history of anything known to alter the blood-brain barrier. Then and now, I continue to have “normal” renal function with an eGFR >60, but yet, I have evidence of long-term retention of gadolinium in my body. If I only had gadolinium in my tissues and no symptoms, I might not worry about it as much, but that is not the case. (more…)