Gadolinium linked to MRI kidney failure gets New Boxed Warning

Jacksonville, FLOn May 23, 2007 the U.S. Food and Drug Administration asked manufacturers to include a new boxed warning on the product labeling of all gadolinium-based contrast agents (used in MRI and MRA scans).

Patients most at risk are those with kidney malfunction, patients just before or after liver transplantation, or patients with chronic liver disease. They have the potential to develop NSF/NFD -- nephrogenic systemic fibrosis or nephrogenic fibrosing dermopathy)-- a debilitating disease that has no cure and can be fatal. Symptoms can appear just days after having a gadolinium injection but can also take up to 18 months to develop. The FDA reports that NSF can develop following a single gadolinium injection.

Patients with NSF develop thickening of the skin and connective tissues that inhibits their ability to move and may result in broken bones. On May 17, 2006 [First Coast News] reported that two people had MRIs done at the Mayo Clinic in Jacksonville last year and both have been recently diagnosed with NSF. Desirae Leonard, 32, is now confined to a wheelchair. "She can't straighten her arms or legs. She can't hold a cup of coffee. She can't bathe herself. She can't feed or dress herself," reports First Coast News. And Korean war veteran Richard Evans, 78, can no longer get out of bed.

This chemical poses particular danger for people with kidney disease but it can also cause a number of side effects in patients without renal problems.

Gadolinium-based contrast agents are used to enhance the quality of magnetic resonance imaging (MRI). The chemical is injected into the veins of a patient to obtain a clear and detailed view of an area to detect abnormalities such as tumors and blood clots. But Gadolinium injection can cause irritation to the vein and potentially causeblood clots and many other serious side effects.

Five gadolinium-based contrast agents have been approved for use in the United States: Magnevist (gadopentetate dimeglumine), Ominiscan (gadodiamide); OptiMARK (gadoversetamide); MultiHance;(gadobenate dimeglumine);and Prohance (gadoteridol), with Omniscan being the most commonly used. The FDA has requested the five manufacturers to add a new boxed warning and a new Warnings section to their labels to describe the risk of developing NSF.

A link between NSF and gadolinium contrast agents was first reported in May 2006 by the Danish Medicines Agency (DMA), Over a four year period, 20 patients in Denmark and 5 patients in Austria developed NSF after the administration of Omniscan®. (All patients had severely impaired renal function.)

In December 2006 the FDA said that patients with "moderate renal insufficiency" are at risk for developing NSF. The agency has so far received about 128 reports of NSF.
According to First Coast News, GE Healthcare, one of the companies that manufactures the agent, sent out an alert to medical professionals in June 2006 warning of a possible link between kidney patients, the contrast agent and NSF. A lawsuit has subsequently been filed in Jacksonville against GE Healthcare claiming that the company was negligent.

If you have had any symptoms within two years of using gadolinium contrast agent, it is recommended that you get tested (a skin biopsy) immediately—early detection may slow the progression of this disease.

Know your rights: If you have been diagnosed with NSF/NFD, you may want to contact a lawyer.