MRI Dye Recall
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Gadolinium-based MRI dyes have been linked to a potentially fatal disease known as NSF , and in May 2007, the Food and Drug Administration ordered the manufacturers of these dyes to add a heightened warning to their product labeling to reflect this risk. The agency has not issued an MRI dye recall, as it is still investigating the products. However, it has reported that at least 25 patients have developed NSF after being injected with a gadolinium-based MRI dye . This is a significant number, considering that only 200 cases of NSF have been diagnosed worldwide.
If you've been diagnosed with NSF after undergoing an MRI procedure, you should consult with an attorney as soon as possible to learn about your legal options. You may be entitled to compensation.
MRI Dyes on the Market
A number of FDA approved gadolinium-based MRI dyes are currently on the market. They include:
- OptiMARK, manufactured by Mallinckrodt, Inc.
- Magnevist, by Bayer Schering Pharma
- MultiHance and ProHance, products of Bracco Diagnostics Inc.
- Omniscan, a GE Healthcare product
None of these products has yet been the subject of an MRI dye recall, despite the risk of NSF and other side effects —including severe allergic reactions and blood clots.
MRI Dyes and NSF
Nephrogenic systemic fibrosis, or NSF, is a relatively new disease; the first case was diagnosed in 1997. Nearly a decade later, the Danish Medicines Agency reported a possible link between the disease and gadolinium-based MRI dyes. Then in 2007, the FDA acknowledged the link but did not issue an MRI dye recall. Consequently, the products are still being used in patients undergoing MRIs.
Some patients who receive an MRI dye injection develop NSF, a disease characterized by fibrosis—or thickening and hardening—of connective tissues and skin. In severe cases, the fibrosis can affect internal organs, causing organ failure and death. According to the FDA, patients who face the greatest risk of developing NSF after receiving MRI dye injections are those with kidney disease or related deficiencies.
Diagnosed with NSF?
You may be entitled to reimbursement for your losses, including medical bills. Even though an MRI dye recall has not been issued, individuals may still be able to hold the product makers responsible for injuries suffered as a result of gadolinium-based MRI dyes. To find out if you are eligible to recover your losses, contact us today.
