The U.S. Food and Drug Administration (FDA) has asked manufacturers to include a new boxed warning on the product labeling of all gadolinium-based contrast agents which are used to enhance the quality of magnetic resonance imaging (MRI).

Certain patients who receive Gadolinium appear to be at an increased risk for developing a serious systemic fibrosing disease, NSF, a serious and Sometimes Fatal Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy.  The patients at risk are those with acute or chronic severe renal (kidney) insufficiency (glomerular filtration rate < 30 mL/min/1.73m2); or renal dysfunction due to the hepato-renal syndrome or in the perioperative liver transplantation period.  In the hepato-renal syndrome or in the perioperative liver transplantation period, the risk applies to any severity of renal dysfunction.

A possible association between NSF and Gadolinium was first reported in a May 29, 2006, press release from the Danish Medicines Agency (DMA) and the April 2006 report by Grobner et al in Nephrology, Dialysis and Transplantation (2006) Vol 21 (4):1104-1108 and following erratum (2006) 21(6): 1745.

Recent publications have provided additional important information implicating a role for Gadolinium in the development of NSF among some patients.  Researchers have found gadolinium in the tissue of patients with NSF (High et al, J Am Acad Dermatol 2007; 56 (1):  21-26).  Also, a retrospective study with Omniscan in about 370 patients with severe renal insufficiency estimated the risk of NSF to be 4% (Marckmann et al, J Am Soc Nephrol 2006; 17:  2359-2362).  A case-control study of the occurrence of nephrogenic fibrosing dermopathy (NFD) indicated that exposure to GADOLINIUM was independently associated with NFD (MMWR 2007; 56(07):137-141).

Together, accumulating data indicate that Gadolinium increase the risk for the development of NSF among patients with severe renal insufficiency or renal dysfunction due to the hepato-renal syndrome or in the perioperative liver transplantation period.

If you have been injured as a result of Gadolinium exposure, you should contact an attorney immediately.  For a free case evaluation, fill out the form below.  An attorney will review your Gadolinium form and may contact you to discuss your claim.