Gadolinium/MRI Dye
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Defective Products
Using gadolinium-based contrast agents (GBCAs) in certain patients with kidney disease could be dangerous and lead to a rare, but serious condition called nephrogenic systemic fibrosis (NSF), according to the U.S. Food and Drug Administration (FDA).
GBCAs are used to enhance images from magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA).
The FDA issued a warning in September 2010, with an update in December 2010. The agency said it was making changes to the drug label to alert physicians about the risk of nephrogenic systemic fibrosis and to ensure that the drugs are used appropriately.
The safety announcement recommends that health care professionals:
- Not use three of the GBCA drugs: Magnevist, Omniscan, and Optimark in patients with chronic severe kidney disease
- Screen patients to identify those who have severe kidney disease before doing a GBCA-enhanced MRI or MRA
- Use patients' clinical histories to screen for kidney function problems
- Do not use GBCAs in patients suspected of having or known to have reduced kidney function
- Monitor for signs and symptoms of NSF in patients receiving GBCA who are suspected to have or known to have kidney disease
- Not repeat using GBCA during a single imaging session
NSF has not occurred in patients with normal kidney function, according to the FDA.
NSF Symptoms and Treatment
The following are signs and symptoms of NSF:
- Scaling, hardening and tightening of the skin
- Red or dark patches on the skin
- Stiffness
There is no effective treatment for NSF according to the FDA warning. The disease can lead to fibrosis (thickening and scarring of tissue) of internal organs which can cause death.
Patients who have the highest risk of developing NSF after GBCA-enhanced MRIs are those who have difficulty eliminating the drug. These include patients with acute kidney injury or chronic, severe kidney disease. The risk of NSF also is increased if given in higher than recommended doses or repeat doses.
Contact an Experienced NSF Attorney
If your doctor diagnoses you with NSF after you have had an MRI or MRA using a gadolinium-based contrast agent, it is time to contact a lawyer. NSF is a potentially lethal disease with no known treatment. Your NSF lawyer can discuss you particular situation to determine if you have a legitimate case. To find out if you qualify, please contact Flood Law Group today.