Gadolinium & Nephrogenic Systemic Fibrosis NSF

Development of Serious and Sometimes Fatal Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy.
The FDA has learned of 25 foreign cases of Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD) in patients with renal failure who underwent Magnetic Resonance Angiography (MRA) with Omniscan. Omniscan and other gadolinium-containing contrast agents are FDA approved for use in Magnetic Resonance Imaging (MRI) but not for MRA. Physicians should carefully assess the need for performing MRI with contrast in patients with advanced renal failure (those currently requiring dialysis or with a Glomerular Filtration Rate (GFR)¡Ü15cc/min) and administer the minimal needed dose of contrast agent if MRI with contrast is necessary. The FDA is further evaluating the possible link between the use of gadolinium contrast agents and development of NSF/NFD.

There are no FDA approved MRA contrast agents.

What is gadolinium and what is its use in clinical medicine?
Gadolinium is a paramagnetic metal ion. Paramagnetic ions, such as gadolinium, move differently within a magnetic field.  This trait makes gadolinium useful for magnetic resonance imaging (MRI). Gadolinium are manufactured by a chelating process, a procedure in which large organic molecules form a stable complex around the gadolinium. The chelate reduces the chances of toxicity that could result from exposure to gadolinium. This stable complex is eliminated predominantly via the kidneys.

Gadolinium are approved by FDA for use with MRI as a contrast agent to provide an improved image of body organs and tissues. Gadolinium are also used for magnetic resonance angiography (MRA), an imaging procedure used to evaluate blood vessels.  The FDA, however,  has not approved Gadolinium for use in MRA.

What is the difference between MRA and MRI?
MRA is a special type of MRI used to study blood vessels. MRA aids the detection of heart disorders, stroke, and vascular diseases.

Can an MRI and MRA be performed without gadolinium-based contrast?
Yes, MRI and MRA can be performed without contrast. MRI with Gadolinium provides additional diagnostic information as compared to MRI without contrast. Although Gadolinium are not FDA-approved for MRA, some radiologists believe that these agents help provide detailed images of blood vessels. 

Are there other approved MRI contrast agents that do not contain gadolinium?
Yes. However, the two other approved MRI contrast agents, Feridex, I.V. (an iron-containing injectable solution) and Teslascan (a manganese-containing injectable solution) are FDA-approved only for the evaluation of lesions of the liver.

Imaging contrast agents, such as iodinated contrast agents are used in Computed Tomography, plain X-ray and X-ray angiography. However, these iodinated contrast agents require X-ray imaging rather than MRI.  These agents also have serious risks such as anaphylaxis (a severe and life-threatening allergic reaction) and kidney damage.

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