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Gadolinium and MRIs

Gadolinium is a metallic element that serves as an active ingredient in Gadoliniumcontrasting dyes used to make magnetic resonance imaging (MRI) scans more vivid and readable. To date, gadolinium-based contrast agents (GBCAs) are the only MRI dyes that have been approved by the FDA. However, they have been found to cause a range of mild to serious side effects, the most severe of which affect patients with kidney and/or liver conditions.

Gadolinium MRI Dyes and NSF

Like many agents used in medical procedures, gadolinium can cause a variety of mild side effects that typically subside as soon as the GBCA is expelled from the patient's system.

However, gadolinium may also cause a severe condition known as nephrogenic systemic fibrosis (NSF). NSF is not only irreversible, it is also debilitating and, in some cases, fatal.

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Dangerous Drug Alert:

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Those who are most likely to develop NSF are patients who have undergone an MRI with a gadolinium-based dye and who:

  • are already experiencing kidney (renal) failure or severe renal insufficiency
  • have recently had a kidney transplant
  • suffer from cirrhosis

Once patients have been diagnosed with NSF, they will need lifelong treatment, which generally entails medications, blood therapies and/or physical therapy. Currently, nearly 200 patients worldwide have developed NSF after use of gadolinium agents.

FDA Warns about Gadolinium MRI Dyes

Given the severity of NSF, the FDA has issued three different public alerts about the risk of NSF (and other side effects) after using GBCAs. These gadolinium warnings, which were made public in 2006 and 2007, have:

  • mandated new labeling for gadolinium products
  • dictated that all gadolinium labels highlight possible risks, including NSF
  • recommended that doctors don't use GBCAs on high-risk patients, unless there is no other way of attaining essential diagnostic information

While the FDA warnings may have prevented some high-risk patients from developing NSF, the warnings come too late for those who have already developed this extremely rare and incurable disease.

Your Legal Rights

Patients diagnosed with NSF after exposure to a gadolinium-based MRI dye may be entitled to compensation for the cost of treating the disease, as well as for any other related losses.

If you have NSF and have been exposed to gadolinium, contact us today. We’ll be happy to evaluate your case and inform you of your legal options.



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Gadolinium Quick Facts

Gadolinium Quick Reference Guide
Other Names: 

Gadodiamide

Date Approved:
May 1982

Manufacturer:
GE Healthcare- Omniscan
Bayer Schering- Magnevist
Mallinckrodt- OptiMARK
Bracco Diagnostic- ProHance and Multihance

Status:
Black Box Warning

Approved Uses:
MRI Contrast agent

Off-Label Uses:
MRA Contrast agent

Serious Side Effects:
Allergic reactions
Headache and Nausea
Inflammation or irritation of blood vessels
Nephrogenic Systemic Fibrosis (NSF)
Nephrogenic Fibrosing Dermopathy (NFD)
Restricted movement of joints
Thick and hard skin
Yellow marks in whites of eye

Common Misspellings:
gadalinium
gadalineum
gadolineum
gadulinium
gadoliniom

Related Topics:
Nephrogenic Systematic Fibrosis (NSF)
Nephrogenic Fibrosing Dermopathy (NFD)
Defective Drugs