The safety concerns were great during 1988-2006. The FDA however approved the first gadolinium based magnetic resonance contrast agent for clinical use in human MRI. In the last ten years, studies have revealed that prolonged exposure, elevated levels of gadolinium may ease NSF in patients with severe kidney disease. Serious health risk exist when patients with kidney disease or renal failure are injected with gadolinium. Their bodies are unable to flush all the gadolinium toxic from their body. The extended exposure to the toxin causes health problems such as, nephrogenic systemic fibrosis (NSF) and nephrogenic fibrosing demopathy (NFD). NSF and NFD lead to serious restricted joint movement wheelchair refinement and occasionally death. Nephrogenic systemic fibrosis or Nephrogenic Fibrosing Dermopathy as some know it is a complication of gadolinium based contrast agents used in imaging studies.
It is similar to scleroderma and scleromyxedema but on distinct difference, NSF is caused by the exposure to gadolinium when patients with renal insufficiently are given gadolinium contrast for a MRI. Patients with NSF most likely develop large patches on the indurated skin with fibrotic nodules and plaques. Some patients develop flexion contractures with accompanying limitation of range of motion. NSF resembles scleromxedema in that it manifests with a proliferation of dermal fibroblasts and dendritic cells, thickened collagen bundles, increased elastic fibers and mucin deposition. This disease is not more common in people with a particular race sex or age. NSF has been reported equally among all age groups and ethnic …show more content…
backgrounds. Some signs of NSF usually show up weeks to months after being administered gadolinium. Patients may feel pain, skin tightness, burning sensation, or pruritus. At a glance NSF resembles scleromxodema or eosinophilic fasciitis. The patient may also have joint contractions or skin lesions. Patients with impaired renal function cannot rid their bodies of all gadolinium, transmetallion occurs which is replacement of the gadolinium from the chelate and forming a free gadolinium ion. Free gadolinium ion may then deposit in different tissues causing inflammation and fibrosis. Patients are at an increased risk of developing NSF if the concurrent infectious, inflammatory tissue, ischemic tissue, recent trauma or surgery. Before patients have a MRI done with gadolinium contrast they should be properly screened for the possible risk of developing NSF. Patients with liver failure or renal transplant, should especially consider alternative contrast agents. There are three categories of gadolinium containing contrast media that are recognized by the ACR as having risk of nephrogenic systemic fibrosis. Group one are agents with the largest number of NSF cases, GADodiamide, Gadopentetate, dimeglumine, and Gadovesisetamide. Group two are agents that have very few conformed cases of NSF, Gadobenate dimeglumine, Gadoteridol, and Gadobutrol. Group three agents have just been added to the US market which are Gadofasveset and Gadoxetic acid. Based on these categories it would appear the agents in group two would be the preferred agent to use in patients that are at a high risk for NSF. However it should be noted the FDA does not differentiate between the groups of agents with respect to the risk of patients getting NSF. The risk should always be weighed against the benefits before using intravenous gadolinium in patients with impaired kidney function. Patients normally do not have a reaction to gadolinium unless they have health issues already.
Gadolinium based contrast agents studies revealed they were linked to brain hypersensitivity in two areas, the dentate nucleus and globus pallidus, which correlated with the number of gadolinium exams. At the present time it is not known what the higher level of hypersensitivity mean but hyper-intensity in the dentate nucleus is associated with people who have multiple sclerosis. Patients with multiple sclerosis have a higher number of enhanced MRI scans. Hyper-intensity of the globus pallidus is linked with liver
dysfunction. Until 2006 the safety concerns regarding all gadolinium based contrast agents were related to short term adverse reactions. These were divided into two very broad categories. “Debatin et al in 1991 stated that gadolinium based contrast agents reactions could be divided into allergic and non-allergic in nature which is now general referred to as physiologic reactions.” The allergic types of reactions were very similar to those the radiologic community were already familiar with. These adverse reactions include sneezing, hives, and anaphylactic reaction. The physiologic reactions were mostly symptoms of nausea and vomiting. On March 24, 2016, Dr. Kenneth Maravilla from the University of Washington concluded from his study that the gadolinium deposits in the brain, tissue, and bone tissues are very, very tiny amounts, such as monogram range.” A stud in May 2015 by a Japanese researcher confirmed previous findings that gadolinium contrast remains in the brain of people who received contrast enhanced MRI scans. This raised questions as to whether the deposits of gadolinium that remained on the brain was harmful. Gadolinium based contrast agents are also linked to life-threating skin thickening. Nephrogenic systemic fibrosis s more common with severe kidney disease. NSF causes the thickening of skin that can be so severe that is can prevent bending and extending your joints. NSF can also develop in our diaphragm, thigh muscles, lung vessels, and lower abdomen, which can be very fatal. Because of the latest results from some of the studies the manufactures of all five gadolinium based contrast agents (magnevist, Malthance, omniscon, optimark and prothlance) the US Food and Drug Administration required them to add a boxed warning and new warnings section to their labels to describe the risk of developing NSF. Since the initial release it is believed that the gadolinium based contrast agent was among the safest drugs in medical usage at the time. The vast majority of short term adverse events are less than 2.5 percent of which are minor, transient and require no treatment or intervention. This is a topic that will continue to bring much attention and activity in the future as they discover more about the true and misunderstanding of what happens when gadolinium enters the body until the exist of all traces and there clinical significance in regard to one of the most valuable classes of diagnostic tools available to modern medicine today.