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Gadolinium Based Contrast Agents Used in MRIs Get New FDA Black Box Warning
Gadolinium Associated with NSF/NSD, a Rare Disorder Plaguing Kidney Patients
Sep 28, 2007 | Parker Waichman Alonso LLP
Today, the Food & Drug Administration (FDA) issued a “Dear Healthcare Professional” letter to inform practitioners of recent changes to the prescribing information for gadolinium based contrast agents used during Magnetic Resonance Imaging (MRI). The letter informs healthcare professionals that a blackbox warning, the FDA’s most serious type of warning, had been added to the product labels. The blackbox warns of the association between the use of gadolinium contrast agents and a rare disorder called Nephrogenic Systemic Fibrosis/ Nephrogenic Fibrosing Dermopathy (NSF/NSD).
NSF/NSD is a debilitating disease that affects people with pre-existing kidney disease. The first case of NSF/NSD was reported in 1997, and it wasn’t mentioned in medical literature until 2000. NSF/NSD leads to excessive formation of connective tissue in the skin and internal organs. It is 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/NSD 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/NSD symptoms to appear, and the disease often progresses very slowly. At this time, there is no treatment or cure for NSF/NSD. However, improved kidney function does seem to slow the development of the disease. Unfortunately, for many patients with NSF/NSD, the only way to improve their kidney function is with a transplant.
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/NSD in patients with pre-existing kidney problems. Following the 2006 discovery, the 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/NSD. Those three were Omniscan 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
In May 2007, the FDA requested that the manufacturers 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. People who are at risk for NSF/NSD 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/NSD caused by gadolinium based contrast agents.
According to the “Dear Healthcare Professional” letter, as of today, the FDA says it is aware of 250 cases of NSF/NSD associated with the use of gadolinium based contrast agents.
