The recent information disclosed about the use of Gadolinium based contrast agents and the development of Nephrogenic Systemic Fibrosis in patients with advanced cases of kidney disease or kidney failure has prompted the American College of Radiology (ACR) to revise its safety guidelines detailing how to safely perform an MRI procedure. The first public health advisory warning of the increased risk was released by the US Food and Drug Administration in December of 2006, with new information being discovered and released on a regular basis. The newly revised safety guidelines for performing an MRI has been modified to include an entire section about the risks of performing an MRI on a patient with advanced kidney disease using a Gadolinium based contrast agent and the patient’s risk of developing Nephrogenic Systemic Fibrosis.
Nephrogenic Systemic Fibrosis is a rare condition, with less than 300 confirmed cases occurring worldwide. The condition was first discovered in 1997 and was formally described in medical literature in 2000. The condition is considered progress and, so far, has only occurred in patients with moderate to advanced kidney disease and kidney failure. NSF causes the increase of deposits of collagen in the skin and connective tissue which causes these areas to harden and become thick. Over time, the connective tissue beneath the affected skin begins to calcify, causing extreme pain and discomfort to the patient suffering from the condition.
In severe cases of Nephrogenic Systemic Fibrosis, the tightening of the skin can restrict the movements of the muscles and joints, causing the joints to become deformed and the muscles to atrophy. In some cases, the restriction can be so severe that attempting movement can cause a bone to break. Nephrogenic Systemic Fibrosis can also affect the internal organs of the body, causing them to thicken and become scarred as well. In most cases, the condition progresses over a matter of months but rarely, the condition progresses rapidly with affected individuals bedridden or in need of a wheelchair within a matter of weeks. Nephrogenic Systemic Fibrosis can be fatal and there is no cure for the condition.
There are five Gadolinium based contrast agents approved by the FDA for use in MRI procedures. Of these, three have been linked to the development of Nephrogenic Systemic Fibrosis in patients with advanced kidney disease, leading officials to believe that all five may contribute to the development of Nephrogenic Systemic Fibrosis. In order to prevent new cases of the condition from occurring, the ACR has revised the MRI safety guidelines to reflect this new information. The changes are as follows:
- It is recommended that individuals with any level of kidney disease avoid using any type of Gadolinium based contrast agent when undergoing an MRI.
- Caution is urged when administering any other type of contrast agent to an individual with advanced kidney disease or kidney failure.
- If a patient with advanced kidney disease does receive a Gadolinium based contrast agent, dialysis may be used to remove the Gadolinium from the body.
- Patients with moderate kidney disease should weigh the risks of developing NSF in their case before deciding either way.
- If dialysis will be needed to remove the Gadolinium based contrast agent from the body, preparations should be made before the MRI is administered and dialysis should commence no later than 2 hours after the Gadolinium based contrast agent has been administered.
- In patients diagnosed with NSF, Gadolinium based contrast agents should be avoided at all costs.
Experts are still working on understanding why or how Gadolinium based contrast agents cause NSF. While they are not completely certain that Gadolinium based contrast agents are the cause of NSF, the facts point to a need for caution.