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Gadolinium-Enhanced MRIs and MRA Scans Information Sheet

Gadolinium-Enhanced MRI and MRA Scans Linked to Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD)

 

FDA ALERTS PHYSICIANS: Gadolinium-based contrast dye may cause fatal disease affecting the kidneys, skin, muscles, joints, and other internal organs.

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FDA Recommends “Black Box” Warnings

 

On May 23, 2007, the Food and Drug Administration (FDA) recommended that manufacturers of all Gadolinium-based contrast agents add “black box” warnings about the risk of patients developing nephrogenic systemic fibrosis (NSF), also known as nephrogenic fibrosing dermopathy (NFD). 

 

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Who may be injured?

 

MRI scanPatients are exposed to Gadolinium during MRI (magnetic resonance imaging) and MRA (magnetic resonance angiogram) medical procedures.  Gadolinium is used to improve the visibility of internal organs.  Recent studies show increased risk for patients with end stage renal disease (ESRD), kidney dialysis patients with chronic or acute renal insufficiency due to hepato-renal syndrome (liver/kidney disease), and patients who have had liver transplants.  Patients with kidney disease or who are on kidney dialysis are at increased risk because Gadolinium is mainly eliminated from the body through the kidneys.

 

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Symptoms of NSF/NSD

 

  • Thickening, swelling and tightening of the skin, usually starting in the legs, but also including the muscles of the thigh and lower abdomen, diaphragm, arms, hands, and lungs
  • Reddened or darkened patches on the skin
  • Burning or itching on the skin
  • Yellow raised spots on the whites of the eyes
  • Difficulty bending the joints
  • Muscle weakness
  • Deep pain in the hip bones or ribs
  • Scarring and thickening of internal organs, leading to organ failure and death

 

 

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Gadolinium MRI Contrast Product Names

 

Between 1988 and 2004 there have been five FDA-approved Gadolinium MRI contrast agents (also called GBCA), all of which could cause problems:

 

  • Onmiscan (gadodiamide)
  • MultiHance (gadobenate dimeglumine)
  • Magnevise (gadopentetate dimeglumine)
  • ProHance (gadoteridol)
  • OptiMARK (gadoversetamide)

 

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Contact Your Doctor!

 

If you or someone you know has had a Gadolinium-enhanced MRI or MRA, you should contact your doctor immediately, especially if you have kidney or liver problems.

 

The time between a patient undergoing an MRI with Gadolinium and developing NSF varies from several days to several months.  NSF can cause severe disability or even death, making it even more important to seek medical help immediately.

 


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Contact Kershaw, Cutter & Ratinoff

 

The attorneys of Kershaw, Cutter & Ratinoff, LLP, have handled hundreds of cases involving dangerous and defective medical products, such as Gadolinium.  We understand that such complex cases demand the knowledge and skill of experienced attorneys.  Our years of experience give you the advantage to prove up your case, even under the most difficult circumstances.

 

If you or someone you know has been exposed to Gadolinium, and may have developed NSF or NFD, especially if you have kidney disease, the experienced attorneys of Kershaw, Cutter and Ratinoff can help.  Please click here for a free case evaluation.

 

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Recent Headlines

 

Gadolinium MRI: Safe if I have kidney problems?

MayoClinic.com — June 11, 2007

 

FDA requests "black box" warning on gadolinium contrast packaging

Diagnostic Imaging Online

— May 31, 2007

 

FDA Orders Black Box Warning for Gadolinium-Based Contrast Agents

MedPage TodayMay 23, 2007

 

FDA Information:

Information on Gadolinium-Containing Contrast Agents

FDA Web Site 2007

 

Information for Healthcare Professionals
Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging

FDA Web Site 2007