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A WARNING ABOUT GADOLINIUM ENHANCED MRIs/MRAs

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FDA Caution on Gadolinium Containing Contrast Agents in Patients with Renal Failure
August 2006
FDA MedWatch Safety Alert 2006 - Gadolinium Containing Contrast Agents for MRI
December 2006
Gadolinium is a contrast dye commonly used in MRIs or MRAs for observation of internal organs, tissues or blood vessels. In the process of the MRI or MRA, the dye is injected into the body intravenously to help detect abnormal tissue. In its free or uncovered form, gadolinium is highly toxic. While MRI and MRA contrast agents containing gadolinium are designed to escape the body quickly, some people, especially those with impaired kidney function, may not be able to secrete it as quickly as necessary.

Gadolinium contrast dyes are marketed under the brand names:
  • Omniscan™ by GE Healthcare
  • OptiMARK by Mallinckrodt/Tyco Healthcare
  • Magnevist by Bayer/Schering AG/Berlex
  • ProHance by Bracco Diagnostics
  • MultiHance by Bracco Diagnostics
On May 23, 2007, the FDA required a Black Box Warning on all MRI contrast dyes containing gadolinium, particularly cautioning those with impaired kidney function, because of a possible link to the development of Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NSD). The disease starts in the skin of the arms and legs and spreads to other parts of the body and internal organs. In advanced stages of the disease, patients may require kidney transplant. NSF/NSD may eventually lead to death. The condition could begin in as little as a few days or even several months after the patient was injected with a contrast agent during an MRI or MRA.

Symptoms of NSF/NSD include:
  • Burning of the skin
  • Hardening or tightening of the skin
  • Itching
  • Muscle weakness
  • Pain deep in the hip bones or ribs
  • Red or dark patches on the skin
  • Stiffness in joints and trouble moving or straightening the arms, hands, legs, or feet
  • Swelling
  • Yellow spots on the whites of the eyes
Motley Rice is investigating cases in which patients with kidney disease experienced any of these symptoms after undergoing a gadolinium enhanced MRI. For more information, please contact Carmen Scott at cscott@motleyrice.com.
Please contact us with any questions or if you'd like to explore your legal rights.