Gadolinium

Gadolinium is a naturally-occurring chemical element used in compounds for a wide variety of commercial and industrial uses. In particular, gadolinium-based contrast agents used in magnetic resonance imaging (MRI) have recently come under attack for the extremely harmful effects they can have on kidney patients.

In December of 2006, the matter had become serious enough that the FDA issued an official alert warning about the "risk of nephrogenic systemic fibrosis (NSF)" caused by "all gadolinium-based contrast agents." The FDA continued with the following recommended boxed warnings:

• Exposure to GBCAs increases the risk for NSF in patients with:
– acute or chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2),or
– acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
• NSF is a debilitating and sometimes fatal disease affecting the skin, muscle, and internal organs.
• Avoid use of GBCAs unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging (MRI)
• Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests.
• When administering a GBCA, do not exceed the dose recommended in product labeling. Allow sufficient time for elimination of the GBCA prior to any readministration.

Five of the gadolinium-based contrast agents that the FDA warned about have been approved for use in the United States:

• Magnevist (gadopentetate dimeglumine)
• Omniscan (gadodiamide)
• OptiMARK (gadoversetamide)
• MultiHance (gadobenate dimeglumine)
• Prohance (gadoteridol)

Worldwide, several hundred cases of NSF have been strongly linked to these and other gadolinium-based contrast agents used in MRIs. Nephrogenic systemic fibrosis affects patients with renal failure and is a progressive and potentially fatal condition. NSF patients develop fibrosis of the skin and connective tissues throughout the body. Contractures may develop as the skin thickens and prohibits proper flexion and extension of the joints. Patients have also been reported to develop widespread fibrosis in other organs.

The signs of NSF can include:

• Burning, itching, swelling, hardening and tightening of the skin
• Red or dark patches on the skin
• Yellow spots on the whites of the eyes
• Stiffness in joints
• Trouble moving or straightening the arms, hands, legs, or feet
• Pain deep in the hip bones or ribs
• Muscle weakness.

If you believe exposure to gadolinium-based contrast agents has put you or a loved one in danger, please fill out our Case Review Contact Form to the right on this page to find out what your case is worth.