Use of Gadolinium in MRIs linked to Untreatable Disorder
Gadolinium (or gadodiamide) is a clear, non-radioactive substance that doctors inject into the bloodstream when a patient is undergoing a Magnetic Resonance Imaging (MRI) procedure. Gadolinium accumulates in abnormal tissue, allowing doctors to observe a contrast between normal and abnormal tissue in the brain and body. Abnormalities, such as small tumors, are highlighted by using gadolinium.
Gadolinium is marketed under several names that have Food and Drug Administration (FDA) approval for use with MRIs, but not Magnetic Resonance Angiography (MRAs). Common brand names include:
Magnevist (manufactured by Bayer)
Omniscan (manufactured by GE Healthcare)
OptiMARK (manufactured by Mallinckrodt Inc.)
MultiHance (manufactured by Bracco Diagnostics)
ProHance (manufactured by Bracco Diagnostics)
Gadolinium-based contrast agents, such as those listed above, are manufactured by a chelating process, whereby large organic molecules form a stable complex around the gadolinium. Gadolinium in its natural state is highly toxic, but the chelating process reduces the chances of toxicity for most individuals.
Medical professionals can perform an MRI or MRA without gadolinium. However, an MRI conducted without gadolinium does not offer comparable diagnostic information to that of an MRI in which a contrast agent was used. The only other FDA approved substances that create contrast for MRIs, have only received approval for evaluating lesions of the liver. As for MRAs, gadolinium-based substances are not approved for use with this type of test; although some doctor’s assert that such agents help provide more detailed images.
How is gadolinium dangerous?
Individuals with kidneys that function normally have the ability to excrete gadolinium from the body using the kidneys. Unfortunately, patients that have poor kidney function often are unable to process gadolinium. For those patients, the use of gadolinium has been connected to a debilitating and untreatable disorder called as Nephrogenic System Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD).
NSF is a condition that causes increased formation of the connective tissue in the skin, otherwise known as fibrosis. The symptoms of fibrosis become most visible on the skin. According to the FDA, NSF victims also often experience some of the following symptoms:
Muscle weakness
Pain deep in the hip joints or ribs
Burning or itching of the skin
Swelling, hardening or tightening of the skin
Limited range of motion in the arms, hands, legs, or feet
Joint stiffness
Reddened or darkened patches of skin
Yellow spots on the whites of the eyes
Fibrosis of the eyes or internal organs
These symptoms may inflict individuals at any time following the administration of gadolinium, from a few days to more than one year after coming in contact with gadolinium. In addition, individuals could develop symptoms even from limited, one-time exposure to gadolinium.
In acute cases, patients may be unable to walk or even fully extend their joints. Patients dealing with worsening symptoms of NSF also run the risk of death. Individuals under a greater than normal risk for developing NSF are those undergoing a liver transplant, both immediately before or after the transplant, and those with chronic liver disease, who have kidney insufficiency.
Steps the FDA has taken
The FDA issued a Public Health Advisory in 2006, which identified a possible link between NSF or NFD and exposure to gadolinium-based agents used at high doses for an MRI. The FDA reported that it had learned of 25 cases of NSF or NFD in patients with kidney failure who received Omniscan and underwent an MRI. At the time, the FDA had not yet determined whether exposure to gadolinium-based agents, during an MRI test, caused NSF or NFD in patients with kidney failure.
The FDA also released a warning indicating that patients with moderate renal insufficiency were at risk for developing NSF. Since that determination, the FDA has further learned that those initial patients were actually experiencing acute renal failure at the time they were in contact with gadolinium. At this point, the FDA has not yet found evidence of NSF in patients with normal renal function or moderate renal insufficiency.
Based on its findings, in May 2007, the FDA mandated a “black box” warning to appear on the boxes of gadolinium-based contrast agents. The warning indicates that patients with advanced renal failure or kidney malfunction risk developing NSF if they receive gadolinium-based agents. Consequently, the FDA advises that such patients should not be tested using gadolinium-based contrast agents, unless it is determined that the diagnostic information that would result from its use is essential and not accessible through other means.
Settlement for some victims
According to Reuters, a number of individual claims that were been filed against Bayer, the maker of Magnevist, were settled for undisclosed terms. The first case against Bayer was filed in 2007 by the mother of a patient who died in 2004 after receiving a Magnevist injection during an MRI. More than 200 cases nationwide have been filed against Bayer, with more likely to be filed against that company and other producers of gadolinium-based products.
What should I do?
If you or a loved one needs an MRI or an MRA, and you have kidney problems, you should consider taking the following precautions:
Notify your doctor about existing kidney problems
Determine whether the test to be performed uses a gadolinium-based agent
If a gadolinium-based product will be used - consult with your doctor about whether it is necessary to use a gadolinium-based product
If you or a loved one has been in contact with a gadolinium based product, and has experienced any of the symptoms outlined above, immediately obtain medical assistance. After receiving medical attention, you should seek the advice of a knowledgeable attorney to protect your interests. The National Justice Coalition is comprised of preeminent consumer attorneys who have extensive experience in product liability matters. Contact the National Justice Coalition for a consultation regarding your particular case.
Use of Gadolinium in MRIs linked to Untreatable Disorder