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• Gadolinium and NSF
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Gadolinium is a chemical used in contrast agents for magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA). According to the U.S. Food and Drug Administration (FDA), the most common gadolinium side effect is an allergic reaction that is often mild but can occasionally be very severe and even fatal. In addition, the FDA recently warned patients and physicians about a potential side effect of gadolinium called nephrogenic systemic fibrosis (NSF), a debilitating and potentially fatal disease with no cure. NSF can develop within days after a single injection of a gadolinium-based contrast agent, or it can take up to 18 months to manifest itself.

On May 23, 2007, the U.S. Food and Drug Administration (FDA) asked the manufacturers of all gadolinium-based contrast agents (GBCAs) to include a new warning on their product labeling. A gadolinium recall has not yet been conducted, but the FDA wants the five FDA-approved GBCAs to have more severe and clear warnings about the link between gadolinium and a debilitating disease called nephrogenic systemic fibrosis (NSF), or nephrogenic fibrosing dermopathy (NFD). The GBCAs are:

• Magnevist® (gadopentetate dimeglumine), made by Bayer Schering Pharma
• Ominiscan® (gadodiamide), made by GE Healthcare
• OptiMARK® (gadoversetamide), made by Mallinckrodt, Inc.
• MultiHance® (gadobenate dimeglumine), made by Bracco Diagnostics Inc.
• Prohance® (gadoteridol), made by Bracco Diagnostics Inc.

Gadolinium and NSF

More than 170 cases of NSF have been reported worldwide since the disease was first reported in 1997. The link between NSF and GBCAs was first reported in May 2006 by the Danish Medicines Agency (DMA), which found that over a four-year period, 25 patients in Denmark and Austria developed NSF after the administration of Omniscan in a magnetic resonance imaging (MRI) procedure.

Several scientists have suggested that the sudden appearance of NSF in the last 10 years indicates that NSF is caused by a new examination method or agent—most likely gadolinium . The potential for a gadolinium recall, at least for Omniscan, cannot be ignored, but none of the gadolinium-containing contrast agents has yet been the subject of recall in the U.S. or Europe.

NSF causes fibrosis (thickening and hardening) of the skin and joints and other connective tissues, and can damage internal organs such as the brain, heart, liver, diaphragm, and spinal cord. There is no known cure, and the progression of NSF can be fatal.

Kidney or Liver Problems Add to NSF Risk

The individuals who are most at risk of developing NSF after being injected with a gadolinium-based MRI contrast agent are those with a kidney problem, because it is the kidneys that normally flush the gadolinium out of the body within a number of hours after its injection. Patients with liver malfunction are also at higher risk. In December 2006, the FDA confirmed that patients with even "moderate renal insufficiency" are at risk for developing NSF when they receive a GBCA.

The FDA also reported that NSF can develop following a single injection of a GBCA, and that symptoms can appear within days after having a GBCA injection or can take up to 18 months to manifest. The FDA has received more than 130 reports of NSF already.

Contact An Attorney

Even though a gadolinium recall has not been conducted by the FDA, patients who have been injured by a gadolinium-based contrast agent may be able to take legal action against the product's maker.

If you have developed adverse symptoms following an MRI, a gadolinium attorney can advise you — even if you don't know whether gadolinium was used or you don't recall the name of the GBCA. Contact a qualified gadolinium attorney today to discuss your case.

"Gadolinium Linked to Nephrogenic Systemic Fibrosis"

The Food and Drug Administration finalized on Friday its earlier action to strengthen the label on certain dyes used for magnetic resonance imaging, or MRI. The dyes will now carry a bold black box to warn of a potentially fatal side effect in some kid...

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