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.

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.

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.

54 year old Margaret Roxbough of Glasgow, Scotland, went for an MRI exam in September 2006.  It was a standard procedure, and she was administered with the Omniscan contrast agent to improve the results of the scan.  However, neither she nor the doctor knew that she had kidney disease.  Without functional kidneys, the body was not able to expel the traces of gadolinium from her body afterwards, and allowing NSF to develop.  Although there was “horrendous pain” the next day, the doctor wrote it off as mild side effects of the MRI scan and said they should go away soon enough.

Margaret Roxbough still experiences excruciating pain.  The skin on her legs is completely raw and it is too painful to cover it with any type of clothing.

In 2004, two years prior to her scan, a woman in Denmark had died from the symptoms of nephrogenic systemic fibrosis.  In 2006, it had been noted by Henrik Thomas that all the patients diagnosed with NSF at his hospital had one thing in common – they were injected with Omniscan, the contrast dye produced by GE Healthcare.

Subsequently, Ms. Roxbough had sued GE Healthcare, and the lawsuit was recently settled.  The FDA now requires a warning label detailing the risks of NSF on Omniscan agents, as well as all FDA regulated gadolinium based contrast agents.

This could have been avoided had it been known she was suffering from renal disease prior to her MRI scan.  It is absolutely crucial that if the doctor suggests the use of a contrast dye for an MRI scan that YOU GET TESTED FOR KIDNEY DISEASE BEFORE THE PROCEDURE to avoid all side effects of gadolinium contrast dye.  If you do have a documented history of kidney complications, be sure to discuss the severity of the problems and how risky a gadolinium based contrast agent would be to your health.

Gadolinium is a rare earth lanthanide metal.  In its original form, it is a silvery white, malleable and ductile metal.  As a free ion, it is a highly toxic element to humans.  It must go through a process known as chelation before it can be utilized in practical applications.  Chelation is the process of taking a free ion and adding bonds with other organic compounds to prevent it from freely and uncontrollably reacting with other elements and compounds that could have detrimental effects.

The reason gadolinium has found its way into MRI scan applications is because of its strong paramagnetic properties.  A paramagnetic metal does not exhibit any magnetic effects in its original state.  When placed in an externally applied magnetic field, it will align its molecules parallel to the it, and in turn, create its own magnetic field.  They are easily detectable in a strong external magnetic field (such as that produced by an MRI machine), allowing the possibility for much more detailed scans.

Gadolinium based contrast dyes have been manufactured to be safe for the patient and they follow strict FDA regulations to avoid any health complications.  However, there are still gadolinium side effects that people must be completely aware of to avoid the risk of harm to themselves.