Gadolinium Contrast Used in MRI / MRA Can Cause NSF & NFDAug 8, 2007 | Parker Waichman LLP, LLP
Gadolinium Contrast Agents have long been Used in Magnetic Resonance Imagining to Enhance the Quality of Images
Gadolinium contrast agents have long been used in Magnetic Resonance Imagining (MRI) to enhance the quality of images. But in some patients, Gadolinium can have a toxic affect, causing a condition known of Nephrogenic Systemic Fibrosis (NSF)
Gadolinium contrast agents are injected into the bloodstream right before an individual undergoes an MRI. The Gadolinium helps the MRI computer to differentiate between normal and abnormal tissue. In 2006, researchers discovered that the use of Gadolinium based contrast agents had a direct correlation to the development of NSF in patients with pre-existing kidney problems. Following the 2006 discovery, the Food and Drug Administration (FDA) warned healthcare professionals that Gadolinium based agents had been tied to multiple cases of NSF. Although these cases were not limited to one Gadolinium based contrast agent, three were most often associated with the onset of NSF. Those three were Ominiscan made by GE Healthcare, Magnevist marketed by Bayer Shering Pharma, and OptiMark manufactured by Mallinckrodt, Inc. At that time the FDA warned physicians to screen patients for kidney problems prior to using a Gadolinium based contrast agents during MRIs.
NSF is a disorder characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can progress to the point of causing severe stiffness in joints, and it can lead to death. It can take some time after Gadolinium exposure for NSF symptoms to appear, and the disease often progresses very slowly. A July article in the New England Journal of Medicine highlighted one instance of a patient with kidney failure who received a Gadolinium based contrast agent, and whose NSF symptoms developed over a four year period. At this time, there is no treatment or cure for NSF. However, improved kidney function does seem to slow the development of the disease. Unfortunately, for many patients with NSF, the only way to improve their kidney function is with a transplant,
FDA Requested that the Manufactures of the Five Gadolinium Based Contrast Agents Used in MRIs Include a Boxed Warning
In May 2007, the FDA requested that the manufactures of the five Gadolinium based contrast agents used in MRIs include a boxed warning on product labels highlighting the risk they posed to patients with kidney problems. The FDA warned that patients who are at risk for NSF should be monitored by their doctors, and told to report any symptoms associated with the condition immediately. The FDA has also set up a reporting program so that healthcare providers can report instances of NFS caused by Gadolinium based contrast agents.
Gadolinium based contrast agents could potentially injure millions of people. According to the National Kidney Foundation, some 20 million people have chronic kidney disease. The foundation also estimates that 20 million more are at increased risk for developing chronic kidney problems. It is vital that patients who are about to undergo an MRI speak with their healthcare providers about the risks associated with Gadolinium based contrast agents.