Gadolinium Side Effects
When undergoing an MRI scan, your doctor may use a gadolinium contrast dye to improve the quality of the results. Generally, the contrast dye is safe to use, which will pass through and exit the body naturally with time. However, there may be side effects which can possibly have severe and fatal outcomes under some circumstances.
Some minor gadolinium side effects include headaches, nausea, light headedness, and a decrease in blood pressure. These should not be a cause for concern. The sudden onsets of these symptoms are most likely just a result of increased anxiety of having the scan or being injected with the contrast dye. They should go away shortly after the scan. Be sure to take it easy if you are feeling uncomfortable and uneasy after your scan.
Other known side effects are a result of an allergic reaction to gadolinium. Complications are usually mild, such as sweating, skin rashes, itching and hives. Potentially fatal complications include irritation of the blood vessels and blood clots.
When people think of severe gadolinium side effects, nephrogenic systemic fibrosis (NSF) is what comes to mind. NSF is a fatal syndrome that results in the fibrosis of soft and connective tissue. This includes the joints, skin and internal organs. The most noticeable effect is that the skin will tighten and harden and the joints will stiffen up, making it harder and more painful to stretch and move parts of the body. It is much easier to develop in patients with a history of renal (kidney) disease and failure.
Nephrogenic systemic fibrosis is a relatively new disease. The first case was reported in 1997, with the first study being published almost 3 years later. It was not until 2006 that gadolinium based contrast agents were linked to nephrogenic systemic fibrosis. Not much is known about how exactly this syndrome emerges, and there is no known treatment option as of today.
It is imperative that patients make it known to their doctors and nurses about their history of kidney complications if there were any. If there is only evidence of slight kidney impairment, contrast dyes may still be used if deemed essential, but it is very important that the proposed guidelines for use are strictly adhered to. It is highly recommended that all patients undergoing their first MRI scan be screened for kidney disease beforehand to avoid all fatal gadolinium side effects.
Nephrogenic Systemic Fibrosis
Nephrogenic systemic fibrosis is a fatal disease that is now commonly linked to gadolinium contrast agents injected into the body, which are used to enhance the clarity of MRI scans. It is the syndrome where excessive fibrous tissue begins to grow on the eyes, skin, joints and internal organs. People with chronic severe kidney insufficiency are at most risk of developing NSF through gadolinium based agents because their kidneys cannot properly excrete the gadolinium from the body over time.
The first appearance of NSF was reported in 1997. The first publication describing NSF was in 2000. And it was not until 2006 that the link between gadolinium based contrast agents and NSF was reported in a press release by the Danish Medicines Agency. Relatively little time has passed since the emergence of nephrogenic systemic fibrosis in the medical field, and the understanding of this syndrome is still in its infancy. As of now, there is still no known treatment plan for NSF. However, research has shown that improving the function of the kidney, either by transplant or by healing processes, can stop NSF or even gradually reverse the effects.
Those stricken with NSF will encounter several painful symptoms. Most noticeably, the patient’s skin will become hardened, swollen and tightened, which becomes painful to stretch. Darkened patches of skin may also appear, as well as a burning and itching sensation of the skin. There will be significant stiffness of the joints, leading to pain and difficult to bend and extend the arms, legs, hands and feet. NSF can also affect internal soft tissue, resulting in deep pains in the ribs and a decrease in muscle strength. Additionally, the whites of the eyes can grow yellow raised spots.
It is very important that those with serious kidney problems consult their doctor on the use of contrast agents. An MRI scan can still provide good data without them, though under some circumstances, they might be deemed essential. If this is the case, be sure to discuss the likeliness of developing NSF and if it is worth the risk. MRI contrast dyes may still be used, but extra precautions must be taken and all guidelines for using gadolinium based agents should be followed exactly.
If you exhibit symptoms similar to those listed above and have recently undergone an MRI scan using a gadolinium contrast agent, call your doctor immediately. If diagnosed with NSF, a secondary course of action is to consult with a lawyer to seek compensation for possible malpractice leading to side effects of gadolinium.
How the FDA Protects Against Side Effects of Gadolinium
Since the discovery of the link between nephrogenic systemic fibrosis and gadolinium based contrast agents, the FDA have investigated the issue ever since, as well as impose regulations of manufactured contrast dyes to follow to reduce gadolinium side effects as much as possible.
The FDA has mandated that all manufacturers add a boxed warning and a new “Warnings” label to describe the risks of use. Currently, there are 5 gadolinium agents that are approved by the FDA:
- Magnevist
- MultiHance
- Omniscan
- OptiMARK
- ProHance
Contrast agents can be used for MRI and MRA scans. MRI machines (magnetic resonance imaging) are used for getting detailed images of the organs and soft tissue in the body. An MRA (magnetic resonance angiography) scan is a specialized type of MRI, which is designed to capture blood vessels and arteries instead. They are mostly used to detect diseases caused by affected blood vessels, such as aneurysms and atherosclerosis disease.
When it comes to FDA regulations, the two types of scans are completely different. The five contrast agents listed above are only approved by the FDA for MRI scans. They are not approved for MRA scans. In fact, there are NO FDA APPROVED CONTRAST AGENTS FOR MAGNETIC RESONANCE ANGIOGRAPHIES. This is important to note, as there are doctors who will still use gadolinium based contrast agents for MRAs because it improves the quality of the results.
There exist other types of contrast dyes that do not contain gadolinium. There are two that are approved by the FDA – Feridex I.V., which is iron based, and Teslascan, which is manganese based. Being as how these two are only allowed for detecting lesions of the liver, they are not viable alternatives. Only the list above is for general MRI scans, and therefore, the possibility of gadolinium side effects still exists.
To learn more about the specific regulations and guidelines imposed by the FDA regarding gadolinium based contrast agents, check out the FDA website regarding MRI contrast agents.
