MRI with Gadolinium Contrast

The FDA has asked manufacturers to include a now boxed warning on the product labeling for all gadolinium-based contrast agents which are used to enhance the quality of magnetic resonance imaging (MRI) or Magnetic Resonance Angrography (MRA). The FDA has learned that patients with severe kidney insufficiency who receive gadolinium-based agents are at risk for developing a debilitating, potentially fatal disease known as Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD). Patients with NSF or NFD develop thickening of the skin and connective tissues that inhibits their ability to move and may result in broken bones. Other organs are at risk of thickening as well. Symptoms of NSF or NFD are skin which thickens and becomes "woody"  and "shiny," tightening of the skin around the joints which impairs mobility, red or dark patches on the skin, yellow spots on the whites of the eyes, swelling, deep hip pain, and muscle weakness.

Presently there are five (5) gadolinium-based contrast agents being used in the United States. They are Magnevist, Omniscan, OptiMARK, Multiance and Prohance. Patients should be screened for kidney problems prior to receiving one of these imaging agents.

In 1997, the first cases of Nephrogenic Fibrosing Dermopathy (NFD) were identified when individuals with impaired kidney function developed areas of thick and hard skin which severely restricted their movement. The condition was later renamed Nephrogenic Systemic Fibrosis (NSF) as additional information was gathered and it was determined that fibrosis, or scarring, can form on other internal organs throughout the system.

In 2006, researchers found there was a direct connection between development of this rare disorder and the use of gadolinium-based contrast agents during magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) for those with kidney problems.

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Davis & Crump is now handling claims for individuals who have been diagnosed with Nephrogenic Systemic Fibrosis (NSF) or Nephronic Fibrosing Dermopathy (NFD). Davis & Crump is experienced in pharmaceutical product liability cases and settlements. If you or a loved one has suffered Nephrogenic Systemic Fibrosis (NSF) or Nephronic Fibrosing Dermopathy (NFD), please contact us at 1-800-277-0300, or send us an email at info@daviscrump.com.