Investigations

Gadolinium, an element used in five different FDA approved contrast agents to more clearly read an MRI or MRA, has been causally linked to Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD), in patients with kidney problems. This side effect only occurs in patients with kidney problems. The FDA has not recalled any of the five FDA approved gadolinium based contrast agents; however, the FDA required the manufacturers of these gadolinium based contrast agents to add a new black box warning on the labels for all gadolinium agents informing patients with kidney problems of the risk of NFS / NFD. 

FDA Safety Warning: First Reported Cases of Gadolinium Use linked to NSF / NFD in Patients with Kidney Problems 

In June 2006, the FDA received a report that detailed twenty-five cases in Denmark and Austria of patients with kidney problems developing NSF / NFD within three months of being injected with a high dosage of gadolinium. This report led the FDA to issue a safety alert to patients with kidney problems, announcing that gadolinium based contrast agents should not be used in high doses in patients with advance kidney problems unless it is clearly necessary. This warning was specifically for gadolinium use in patients with kidney problems during an MRA. An MRA requires the use of three times the approved dosage of gadolinium to be effective. Patients with kidney problems may have difficulty expelling such large amounts of gadolinium. The FDA will further investigate NSF / NFD to determine if it is a side effect of gadolinium in patients with kidney problems.

Second FDA Safety Warning to Patients with Kidney Problems

In December 2006, the FDA issued a second warning after it received ninety reports of NSF / NFD in patients with kidney problems who received a gadolinium based contrast agent for MRIs and MRAs. Additionally, there were about 215 reported cases of NSF / NFD in patients with kidney problems worldwide. Of those 215 patients with kidney problems, 75 cases were studied in detail and all seventy-five individuals who suffered from NSF / NFD had been injected with gadolinium for an MRI or MRA. These reports prompted the FDA to warn patients with kidney problems that even the approved dosage of gadolinium contrast used during MRIs could cause NSF / NFD.

FDA Boxed Warning for Gadolinium in Patients with Kidney Problems

In May 2007, the FDA ordered all manufacturers of gadolinium based contrast agents to include a new boxed warning, specifically addressing patients with kidney problems. The warning required Gadolinium manufacturers to state that patients with kidney problems or renal failure are at risk of developing NSF / NFD if injected with gadolinium. The FDA also announced that it will continue to investigate the connection between NSF / NFD in patients with kidney problems and gadolinium based contrast agents. It also asked all persons with kidney problems who have been diagnosed with NSF / NFD to report their symptoms to the FDA.  

Are you a Patient with Kidney Problems Injured by Gadolinium?

If you would like more information on the Gadolinium recalls or if you or a loved one has kidney problems and has been injured by Gadolinium, please contact us today.