Regulatory Action Regarding Gadolinium Contrast Dyes

Despite the fact that MRA procedures are not an approved use of Gadolinium Contrast Dyes, this dangerous practice continues to grow, putting countless people at risk for NSF. According to the National Kidney Foundation, some 20 million people have chronic kidney disease. Obviously, Gadolinium Contrast Dyes used off-label in MRA procedures have the potential to injure millions. For this reason, the FDA has taken steps to warn the medical community and the public about the potential for Gadolinium Contrast Dyes to cause NSF when used in MRI or MRA procedures.

In recent years, the FDA has issued several warnings regarding the correlation between NSF and Galodinium Contrast Dyes used in MRI. In June 2006, the FDA announced that it had learned of 25 cases of patients with kidney failure who received a Gadolinium Contrast Dye for an MRA prior to their diagnosis. At the time, the FDA cautioned that Gadolinium Contrast Dyes, especially at the high, unapproved doses required for MRA, should be avoided unless they are clearly necessary in patients with advanced kidney failure.

In 2007, the manufacturers of the 5 approved Gadolinium Contrast Dyes added black box warnings to the product labels about the risk of NSF in patients with kidney disease. The FDA warned that patients who are at risk for NSF should be monitored by their doctors following procedures with Gadolinium Contrast Dyes.

Despite the ever-increasing evidence that Gadolinium Contrast Dyes used in MRA and MRI procedures puts kidney patients at risk of developing NSF, these agents are still used with great frequency. The MRA-NSF injury attorneys at Parker Waichman LLP are committed to obtaining the best financial results for the victims of MRA-NSF injuries so that they are able to sustain a high quality of life in spite of their devastating NSF diagnosis.