Gadolinium is a rare-earth metal used in the medical field because it is effective in X-ray, magnetic resonance imaging (MRI), computed tomography (CT), angiography, and ultrasound imaging.
The chemical helps to produce detailed images of internal organs to detect disease or abnormalities in the body. Gadolinium contrast agents were originally approved for MRI scan use in 1988, and now the most commonly used MRI medium.
But the use of products using the substance have raised concerns as the use has resulted in severe and debilitating injuries. Gadolinium-based contrast agents (GBCAs) may remain in the body and cause permanent injuries and conditions like Gadolinium Deposition Disease (GDD) and nephrogenic systemic fibrosis (NSF).
The U.S. Food and Drug Administration (FDA) recently issued a “Drug Safety Communication” warning that noted Gadolinium-based contrast agents (GBCAs) may be retained in the body, and new class warnings are required for manufacturers of contrast agents. The FDA aims to minimize the risk of contrast dye retention.
Even if Gadolinium Deposition Disease (GDD) and nephrogenic systemic fibrosis (NSF) are very rare complications, they are serious enough to warrant an investigation into the safety of the medical product. The FDA acknowledged that NSF in particular is associated with the use of GBCAs in certain patients with kidney dysfunction.
Joe Lyon is a highly-rated Cincinnati, Ohio medical device attorney actively involved in product liability litigation nationwide.
FDA Gadolinium Warnings
The FDA announced a class warning requirement and other safety measures for all companies distributing gadolinium-based contrast agents (GBCAs) for MRI imaging. Gadolinium retention has not been linked to adverse health effects in patients with normal kidney function, though other risks may exist for patients.
The FDA announced it is requiring several actions to alert health care professionals and patients about gadolinium retention after an MRI using a GBCA, including a patient Medication Guide that every patient will be asked to read before receiving a GBCA. The FDA is also requiring GBCA manufacturers to conduct further studies to assess the safety of these agents.
The U.S. Food and Drug Administration (FDA) has suggested that health care professionals consider potential retention characteristics of imaging agents when choosing a GBCA for patients at higher risk for gadolinium retention. Such patients include those requiring multiple doses, pregnant women, children, and patients with inflammatory conditions. Ohio doctors are urged to minimize repeated GBCA MRI imaging tests when possible.
Nephrogenic Systemic Fibrosis (NSF)
Nephrogenic systemic fibrosis (NSF) is a disease possibly caused by Gadolinium exposure, the first diagnosis occurring in 1997. The Centers for Disease Control and Prevention (CDC) has compiled information about 315 patients with NSF, and there are few effective treatments.
There have been no reports of NSF in patients with normal kidney function, though patients suspect you may have kidney issues, they should be screened prior to receiving any contrast dyes or imaging agents. The recommended dose should be carefully controlled and doctors should ensure that a dose has been eliminated from the body before the agent is administered again.
Nephrogenic Systemic Fibrosis (NSF) may develop shortly after injection of a contrast agent, or may take up to 18 months to fully develop. Initial signs and symptoms of Nephrogenic Systemic Fibrosis (NSF) may include:
- Pain—aching or burning sensations
- Paresthesia—tingling or prickling pain, typically in extremities or joints, or near the location where an MRI occurred
- Dermal changes—tight skin, lesions, itchy skin, hyperpigmentation, dark patches on skin
- Muscle spasms—rapid contractions and weakness
- Vision problems—worsening vision or dry eyes, yellow spots on the whites of eyes
- Cognitive symptoms
- Ear, nose and throat – tinnitus, swallowing, and voice problems
- Low body temperature
- Hair loss
- Balance issues
- Swelling of extremities
- Scarring of body organs
- Muscle weakness
What is Gadolinium Deposition Disease (GDD)?
Gadolinium Deposition Disease occurs in individuals with normal renal function who develop symptoms that arise within a few hours to two months after the administration of dangerous and toxic contrast agents.
Until recently, a diagnosis for GDD patients with near normal renal function did not exist, making the disease a relatively new theory, and thus it is unclear how many individuals suffer from Gadolinium Deposition Disease.
Symptoms are similar to NSF (seen above), but may differ in a few notable signs, such as:
- Persistent headache
- Persistent bone and joint pain
- Unclear, foggy thoughts
- Soft tissue thickening—skin may appear spongy or rubbery, without the hardness and redness observed in NSF
- Tendon and ligament pain
- Tightness in extremities
Gadolinium Contrast Dye Injury
Researchers at the Mayo Clinic have found direct evidence of gadolinium deposition in neuronal tissues in patients undergoing MRI scans with gadolinium-based contrast agents. Gadolinium exposure can affect the kidneys and lead to nephrogenic systemic fibrosis (NSF), and lawyers claim the MRI scan contrast agents have led to problems in other organ systems as well.
In May 2007, an FDA kidney specialist issued a report of an “undeniable and strong association” existing between contrast agents containing Gadolinium and NSF. Patients facing a significant risk of developing NSF include those suffering from kidney malfunction, advanced renal failure, liver transplantation patients, and people suffering from chronic liver diseases.
Toxic Contrast Dye
MRI scans are important diagnostic medical tests used to produce images of the body to detect problems such as cancer, infections or bleeding. GBCAs are the intravenous drugs that contain gadolinium, used to help improve visualization of internal organs, blood vessels and tissues.
GBCAs are injected into a vein during an MRI, and are thought to be mostly eliminated from the body through the kidneys. Studies show, however, that trace amounts of gadolinium may stay in the body long-term, making it an imperative for health care professionals in Ohio to consider the retention characteristics of each agent.
The most commonly used contrast agents, approved for use by the FDA, include the following products:
- OmniScan (gadodiamide)—GE Healthcare
- OptiMark (gadoversetamide)—Mallinckrodt/Tyco Healthcare
- Prohance (gadoteridol)—Bracco Diagnostics
- Magnevist (gadopentate dimeglumine)—Bayer/Schering AG/Berlex
- MultiHance (gadobenate dimeglumine)—Bracco Diagnostics