“Black Box” Label for MRI Dyes Finalized

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October 1st, 2007

"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 kidney and liver patients.

In May, the FDA announced that gadolinium-based contrast agents would receive the heightened warning after reports linked the agents to a rare and deadly disease known as nephrogenic systemic fibrosis (NSF).

The disease is characterized by a thickening of the skin, organs, and other tissues and there is currently no cure or effective course of treatment. According to one study, the risk of NSF in patients with severe kidney insufficiency who receive an injection with a gadolinium-based dye is 4 percent.

Patients scheduled to undergo an MRI should be screened for kidney problems first. The FDA said no cases of NSF have been reported in patients with normal kidney function.

(Source: Reuters online)

Diagnosed with NSF? Contact an attorney today to discuss your legal options.