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FDA action is urgently needed on MRI contrast agent safety issues
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…)
New study of Gadolinium retention in brains of rats raises more questions than it answers
On June 22, 2015, an article in Investigative Radiology was published online ahead of print. The study by Robert et al, T1-Weighted Hypersignal in the Deep Cerebellar Nuclei After Repeated Administrations of Gadolinium-Based Contrast Agents in Healthy Rats – Difference Between Linear and Macrocyclic Agents”, describes for the first time “an animal model reproducing closely the recent clinical observations of cerebellum T1 signal hypersignal”. “It also introduces an animal model to investigate the mechanism of the brain retention observed after repeated administrations of some GBCA.”
After 20 intravenous injections of 0.6 mmol of gadolinium per kilogram (4 injections per week for 5 weeks) of gadodiamide (Omniscan) or gadoterate meglumine (Dotarem) to healthy rats, they found that repeated injections of gadodiamide are associated with “progressive and persistent T1 signal hyperintensity in the deep cerebellar nuclei (DCN), with Gd deposition in the cerebellum in contrast with the macrocyclic GBCA gadoterate meglumine for which no effect was observed”. Although repeated doses of gadoterate meglumine (Dotarem) did not cause signal increases, detectable concentrations of gadolinium were found in the cerebellum, cerebral cortex, and subcortical brain of the rats that were injected with it. (more…)
Study suggests Gadolinium Deposition in Dentate Nucleus with MultiHance – Patients had normal renal function
Another 2015 study in Radiology reports findings consistent with gadolinium deposition within the brains of patients with normal renal function (eGFR >60). The 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”, compared gadodiamide (Omniscan) and gadobenate dimeglumine (MultiHance). The findings related to multiple administrations of gadodiamide are “in agreement with other investigators, who documented signal intensity changes associated with this contrast agent despite the presence of normal renal function”. The authors also reported that, “A significant trend toward relative change in signal intensity was seen in the dentate nucleus (DN), but not in the globus pallidus (GP) after serial applications of gadobenate dimeglumine, suggesting that some gadolinium deposition also may occur with this agent”.
For the first time in the literature, the study established gadolinium accumulation related to the use of gadobenate dimeglumine, which is better known as MultiHance. Of note is the fact that there are no unconfounded cases of NSF associated with the linear ionic gadolinium-based contrast agent (GBCA), MultiHance. However, in this study, the patients in each group had received only one brand of GBCA. Group 1 was comprised of 23 patients that had received between 3 and 11 doses of Omniscan, and Group 2 included 46 patients that had received between 3 and 11 doses of MultiHance. All patients had normal liver and renal function. (more…)
June 2015 Podcast of Group Discussion on gadolinium-based contrast media
If you would like to see and hear some of the experts discuss the issues surrounding gadolinium retention from gadolinium-based contrast agents, you should check out the June 2015 Radiology Podcast moderated by Herbert Y. Kressel, MD, Editor of Radiology. It can be found here – http://pubs.rsna.org/page/radiology/podcasts. You can also view it here – https://www.youtube.com/watch?v=gmgv6EvGw0o
Guests are:
Alexander Radbruch, MD, JD, Department of Neuroradiology, University of Heidelberg Medical Center, Heidelberg, Germany
Robert J. McDonald, MD, PhD, Department of Radiology, College of Medicine, Mayo Clinic, Rochester, Mn
Emanuel Kanal, MD, Department of Radiology, University of Pittsburgh Medical Center, Pittsburgh, Pa
Michael F. Tweedle, PhD, Department of Radiology and James Comprehensive Cancer Center, Ohio State University, Columbus, Ohio
Contributor:
Tomonori Kanda, MD, PhD, Department of Radiology, Teikyo University School of Medicine, Tokyo, Japan (more…)
Gadolinium Toxicity 