Gadolinium, or gadodiamide, is a clear, non-radioactive chemical compound that is administered to a person during a magnetic resonance imaging (MRI) scan to help distinguish between new and old cancerous lesions. Usually, several scans are taken: one before the contrast agent is injected and at least one after. After it is injected into a vein, Gadolinium accumulates in the abnormal tissue that may be affecting the body or head.
Gadolinium causes these abnormal areas to become very bright (enhanced) on the MRI. Gadolinium is the most common type of contrast liquid used in conjunction with an MRI scan.
Gadolinium is a contrast material injected at the time of an MRI to provide greater contrast between normal tissue and abnormal tissue in the brain and body. Gadolinium is also helpful in finding small tumors by making them bright and easy to see.^ Back To Top
The FDA declared Gadolinium safe for use in MRI scans in 1988 to provide greater image detail when viewing the brain and connective tissues such as spinal discs, cartilage, scar tissue, soft tissue tears, tumors, etc. Gadolinium is used in pre and post surgical patients, but more commonly for post-operative imaging.^ Back To Top
Side effects most commonly associated with the administration of Gadolinium-containing contrast agents include mild headache, nausea, rash, sweating, itching, hives, and facial swelling. Most of these conditions are considered allergic in nature. These agents can also be very irritating to the veins into which injected, with superficial inflammation or irritation of blood vessels and blood clots occurring.
The Danish Medicines Agency (DMA) issued a press release on May 29, 2006, that reported patients with renal failure developing a rare, potentially life-threatening condition called Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD) after being administered Gadolinium-containing contrast agents. The DMA was concerned because all patients received a Gadolinium enhanced MRI procedure a few weeks to a few months before developing NSF/NSD.^ Back To Top
Gadolinium is contraindicated in patients who have allergic reactions to iodine.^ Back To Top
What is Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD)?
NSF/NFD is a disease that causes fibrosis of the skin and connective tissues throughout the body, and can be found in patients who have noticeably advanced renal failure. Patients develop skin thickening that may prevent bending and extending joints, resulting in decreased mobility of joints. In addition, patients may experience fibrosis that has spread to other parts of the body such as the diaphragm, muscles in the thigh and lower abdomen, and the interior areas of lung vessels. NSF/NFD is progressive and can be fatal.
What will the FDA do regarding the new information about Gadolinium administration and the development of NSF/NFD in patients?
The FDA is continuing to evaluate these reports, is undertaking discussions with experts in the field, will review results of previous and ongoing clinical trials with Gadolinium-containing contrast agents, and is working with the manufacturers to review all safety reports and adverse event reports. The FDA will assess all available information to determine if product labeling changes or other actions are necessary for Gadolinium-containing contrast agents.
Can I pursue legal action if I have suffered health complications from being administered Gadolinium?
The FDA is continuing to evaluate these reports, is undertaking discussions with experts in the field, will review results of previous and ongoing clinical trials with Gadolinium-containing contrast agents, and is working with the manufacturers to review all safety reports and adverse event reports. The FDA will assess all available information to determine if product labeling changes or other actions are necessary for Gadolinium-containing contrast agents.^ Back To Top
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