Gadolinium-Based Contrast Agents

The Cause of Nephrogenic Systemic Fibrosis (NSF)

Gadolinium-based contrast agents are drugs administered intravenously for magnetic resonance imaging (MRI), magnetic resonance angiography (MRA), and other medical scans. Contrast agents with gadolinium are the only known cause of Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD), a horrible and potentially fatal disease. Gadolinium-based contrast agents most frequently cause NSF in dialysis patients, kidney transplant recipients, and people suffering renal (kidney) failure or other impaired kidney function, as well as those with liver disease.

Gadolinium: a Rare Earth Element

Gadolinium (Gd), atomic number 64, is a silvery-white, rare earth metal. It is one of fifteen elements that comprise the lanthanoid (or lanthanide) series in the periodic table of elements. The para-magnetic properties of gadolinium mean it can help produce vivid images when used in contrast agents for magnetic resonance imaging (MRI) and other medical imaging techniques.

Gadolinium is never found in nature as a free element, just in many rare minerals. Gadolinium compounds are used in the fabrication of various optical components, as well as color TV tubes, compact discs, computer memory, and even rocket fuel.

What gadolinium does not have is any known native biological role, meaning it never naturally appears in the human body. In fact, as a free ion, gadolinium is highly toxic to human tissue.

Gadolinium-Based Contrast Agents

Because gadolinium is a solid at room temperature, and is toxic to human tissue, it must be combined with other substances to make it a liquid that can be injected into the human body. This process is called “chelation.” Chelation eliminates the toxicity of gadolinium by binding it to the chelate. The resulting product is a gadolinium based contrast agent.

Side Effects of Gadolinium-Based Contrast Agents

Gadolinium-based contrast agents are potentially dangerous because the binding of gadolinium to the chelate is temporary. If the contrast agent remains in the human body for more than twenty hours, it begins to break down, releasing toxic gadolinium into the body. This can cause the disease known as nephrogenic systemic fibrosis (NSF), also known as nephrogenic fibrosing dermopathy (NFD).

Dialysis and Kidney Patients Most at Risk From Gadolinium-Based Contrast Agents

The unstable nature of gadolinium-based contrast agents explains why people with kidney problems are most at risk. The kidney is the organ in the human body that cleans the blood, filtering out impurities. When a gadolinium-based contrast agent is injected into the body, it puts a great strain on the kidneys, which immediately begin filtering it out of the blood stream. When a person’s kidneys are not functioning properly, they are unable to remove it from the body quick enough. The contrast agent begins breaking down, releasing the toxic gadolinium from the chelate into the body. This is most likely to occur with people on dialysis, along with anyone else who has impaired renal (kidney) function when the contrast agent is injected. Because nephrogenic systemic fibrosis (NSF) is caused by the release of the gadolinium from the contrast agent into the body, dialysis patients and others with impaired kidney function are most at risk -- their kidneys are unable to remove the contrast agent from their bodies before it starts breaking down.

However, even people who previously had no kidney problems are at risk of developing NSF. Renal failure (kidney failure) is one of the known risks of gadolinium-based contrast agents. This means that any person’s kidneys could fail when injected with the contrast agent. If a person’s kidneys fail after receiving the contrast agent and are not immediately put on dialysis, they are also at risk of developing NSF because their bodies also may not remove the contrast agent before it begins breaking down. Thus, even someone who had no kidney problems before receiving the contrast agent could potentially develop NSF.

The Food and Drug Administration (FDA) Warns of the Danger From Gadolinium-Based Contrast Agents

The Food and Drug Administration (FDA) has recognized the danger to kidney patients from gadolinium-based contrast agents. The FDA ordered manufacturers to place a “black box warning” on gadolinium-based contrast agents, which is the greatest step the FDA can take short of ordering a product to be completely recalled from the market. The FDA also ordered manufacturers to send letters to health care providers to warn them of the risks of gadolinium-based contrast agents.
Links:  FDA Alert
            Dear Healthcare Professional Letter

Names and Manufacturers of Gadolinium-Based Contrast Agents

Since 1988, the FDA has approved seven gadolinium-based contrast agents for use in magnetic resonance imaging (MRI), all of which are subject to the FDA warning. These are:

          Omniscan, manufactured by GE Healthcare.

          Magnevist, manufactured by Bayer Healthcare.

          OptiMARK, manufactured by Mallinckrodt.

          MultiHance, manufactured by Bracco.

          ProHance, also manufactured by Bracco.

          Eovist, also manufactured by Bayer Helathcare, and

          Vasovist (new name Ablavar), manufactured by Lantheus (formerly Epix).

Importantly, with the exception of Vasovist, gadolinium contrast agents are only approved for use in MRIs. Nevertheless, common unapproved uses include magnetic resonance angiography (MRA), angiogram/angioplasty, CT scan, fistulogram, and venogram.

The risk of developing NSF from unapproved uses is even greater than for an MRI because unapproved uses often use significantly larger doses of the contrast agent. This places an even greater strain on the kidneys because there is more gadolinium to be removed from the body -- and consequently increases the chances of the contrast agent breaking down in the body before it is completely removed.

In theory, all brands of gadolinium-based contrast agents have the potential to cause NSF, especially for people on dialysis or with any significant level of kidney function impairment at the time the contrast was injected. This is because if not removed from the human body, gadolinium-based contrast agents will eventually break down, releasing free gadolinium into the body.

The Most Dangerous Contrast Agents: Omniscan, Magnevist, and Optimark

Three brands of gadolinium-based contrast agents are far more likely to cause NSF because they are less stable, and therefore more likely to break down in the in the human body. These more dangerous brands are Omniscan, Magnevist, and OptiMARK.

        LEARN MORE ABOUT OMNISCAN
        LEARN MORE ABOUT MAGNEVIST
        LEARN MORE ABOUT OPTIMARK

How to Determine Whether Gadolinium Was Used in Your Treatment

A gadolinium-based contrast agent is always administered intravenously (injected). If you drank the contrast agent for your treatment rather than having something injected, you did not receive a gadolinium-based contrast agent.

Gadolinium Lawsuits

Drug manufacturers are being sued because they failed to warn both doctors and patients of the harmful side effects of gadolinium-based contrast agents. The manufacturers of gadolinium-based contrast agents knew of the risks to kidney and liver patients, but did not disclose that information to doctors and patients. The manufacturers of gadolinium-based contrast agents knew that their products came with a risk of developing nephrogenic systemic fibrosis (NSF) and nephrogenic fibrosing dermopathy (NFD), but they concealed this risk. The manufacturers only warned doctors and patients after they were ordered to do so by the FDA.

Because of the manufacturers’ concealment of the dangers of their drugs and their failure to warn of the side effects, many lawsuits have been filed against the manufacturers of gadolinium-based contrast agents. People who have been exposed to these drugs and who are suffering from NSF/NFD symptoms should contact the gadolinium attorneys at DeCarli Law to learn about their rights and possible compensation.

Symptoms of Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD)

Common symptoms of NSF/NFD include:

• Swelling, thickening and tightening of the skin, especially on the legs or arms;
• Skin is hard, and feels “woody” or "leathery";
• The skin has an "orange peel" appearance;
• Hair loss on the affected area of the skin;
• Joints contract and become inflexible, especially the hands, wrists, elbows or feet, ankles, knees;
• Yellow papules in the whites of the eyes;
• Severely affected people may be unable to walk or close their hands.

Symptoms of NSF begin within a few days to several months after being injected with gadolinum.  Go HERE to read more about Nephrogenic Systemic Fibrosis (NSF).

Contact DeCarli Law for a free consultation if you or a loved one may have developed NSF or NFD after treatment with a gadolinium-based contrast agent.

We represent all individuals suffering from NSF or NFD in a gadolinium lawsuit or NSF lawsuit on a contingency basis. This means you pay no legal fees unless we win compensation in your case. For a free no obligation consultation, please call toll free at 1-800-401-4720 or fill out our short online contact form. A Gadolinium NSF lawsuit attorney will contact you to answer any of your questions.

We charge no legal fees or expenses unless you receive compensation.