FDA Warns Doctors About Gadolinium-Based Contrast Agents

Today FDA warned doctors about gadolinium-based contrast agents used in magnetic resonance imaging (MRI). Some of the companies that provide gadolinium-based MRI dyes to radiologists include: Magnevist, MultiHance, ProHance, Omniscan, and OptiMARK.

FDA has requested the companies above to provide new warnings to doctors about the risk of nephrogenic systemic fibrosis (NSF) with the use of GBCAs in MRIs. The new prescribing information FDA is requesting highlights and describes the risk for NSF following exposure to a GBCA in patients with acute or chronic severe renal insufficiency and patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri-operative liver transplantation period. Healthcare professionals should avoid the use of a GBCA in these patients unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance imaging.

- Read the full press release here at the FDA website -

Gadolinium Dyes and Nephrogenic Systemic Fibrosis NSF

While it is not yet known why Nephrogenic Systemic Fibrosis (NSF) has become so much more common in the last eight years, some research has suggested a link between NSF and Gadolinium used in MRIs or CT scans. One such study, conducted by Dr. T. Grobner from the Department of Nephrology, General Hospital of Wiener Neustadt, Austria noted that five out of nine patients diagnosed with NSF had received an MRI which involved the use of Gadolinium-based dyes as a contrast agent. These dyes were manufactured by GE.

Although the FDA has not yet recalled Gadodiamide for use in products, they have sent out warnings about the use of gadolinium-based contrast agents in patients with kidney disease. They have also created a page about Gadolinium-Containing Contrast agents on which they state: "The FDA is evaluating important safety information about gadolinium-containing contrast agents and a disease known as Nephrogenic Systemic Fibrosis or Nephrogenic Fibrosing Dermopathy (NSF/NFD) that occurs in patients with moderate to severe kidney disease."

We urge any patient who has received or who is about to receive an MRI or CT Scan to review the information, including PDF files and public health advisories, on the above FDA information page.

If you have any of the symptoms of Nephrogenic Systemic Fibrosis (NSF) we suggest you contact your physician immediately so you can be properly tested and diagnosed. This is a serious illness!

Patients who have developed NSF after receiving an MRI or CT Scan that involved the use of Gadodiamide or Gadolinium-containing contrast agents may obtain more information from this Gadolinium attorney's page, this Wikipedia entry, and this page by the Food and Drug Administration about Gadolinium caused NSF investigations.