Gadolinium MRA Contrast Dye Side Effects Information

Gadolinium MRA contrast dye was first approved by the Food & Drug Administration (FDA) for use in Magnetic Resonance Imaging (MRA) in 1988. Soon after gaining FDA approval, Gadolinium MRA contrast dye became the preferred contrast agents in MRIs administered to patients with kidney problem, as they were thought to be safer than other iodine based contrast agents. But since then, the use of Gadolinium MRA contrast dye in kidney patients has been linked to a serious Gadolinium side effect known as (Nephrogenic Systemic Fibrosis) NSF or (Nephrogenic Fibrosing Dermopathy) NSD. NSF or NFD is a rare and sometimes fatal disorder that causes thickening and hardening of the skin in patients with pre-existing kidney disease. The Gadolinium MRA Contrast dye side effect attorneys at Parker Waichman LLP are currently evaluating Gadolinium MRA Contrast dye injury cases where victims have been afflicted with NSF and NFD.

Currently, five Gadolinium MRA contrast dyes are approved for use in the United States: Omniscan, Optimark, Magnevist, Multihance and Prohance. Gadolinium is used in MRIs because its magnetic properties allow healthcare professionals to better observe lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues. When these agents are used, a baseline MRA of the patient is taken. Then the Gadolinium based MRA contrast dye is injected into the patient’s blood stream and a second MRA is done.

NSF or NFD only affects about 215 people around the world, and the first cases were only reported in 1997. NSF or NFD is marked by high blood pressure, thickening of the skin, swelling of the skin around the joints, pain deep in the hip bones, muscle weakness and hardening of soft tissues. NSF or NFD can cause patients to loose mobility and it can lead to death. There is no cure for NSF or NFD, although improving kidney function can put the disease into remission. However, often the only way to accomplish this is through a kidney transplant.

Few studies have been done on NSF or NFD, but in 2006 a breakthrough did shine some light on this devastating disease. That year, a study conducted by the Danish Medicines Agency found that of 9 NSF or NFD patients, 5 experienced the onset of symptoms after they had undergone MRIs that involved the use of Gadolinium MRA contrast dye. A few other studies soon reached similar conclusions, and by December 2006, 90 patients with moderate to end-stage kidney disease were known to have developed NSF or NFD after they had an MRA with a Gadolinium MRA contrast Dye.

In 2006, the FDA warned health care professionals about the link between Gadolinium MRA contrast dye and the occurrence of NSF or NFD. Then in 2007, the FDA requested that that the manufacturers of Gadolinium MRA contrast dye update their products’ labels to include a black box warning regarding the risk of NSF or NFD in patients with kidney problems. The FDA also started a monitoring program to track the frequency NSF or NFD related to gadolinium contrast dye.

Gadolinium is a silvery, malleable metal that is found on the periodic table. Gadolinium is a paramagnetic metal ion, which causes it to move differently than other elements within a magnetic field. As a result gadolinium lends itself to many useful applications. For example, gadolinium is used for making gadolinium yttrium garnets, which have microwave applications, and gadolinium compounds are used for making phosphors for color TV tubes. Gadolinium is also used for manufacturing compact discs and memory, and it is used in x-ray. It is also used in the nuclear power industry.

Gadolinium based contrast agents were first approved by the Food & Drug Administration (FDA) for use in Magnetic Resonance Imaging (MRA) in 1988. Currently, five gadolinium based contrast agents are approved for use in the United States: Omniscan, Optimark, Magnevist, Multihance and Prohance. Gadolinium is used in MRIs because its magnetic properties allow healthcare professionals to better observe lesions with abnormal vascularity (or those thought to cause abnormalities in the blood-brain barrier) in the brain (intracranial lesions), spine, and associated tissues. When these agents are used, a baseline MRA of the patient is taken. Then gadolinium is injected into the patient’s blood stream and a second MRA is done.

Soon after gaining FDA approval, gadolinium based contrast agents became the preferred contrast agents in MRIs administered to patients with kidney problem, as they were thought to be safer than other iodine based contrast agents. But since then, the use of gadolinium contrast agents in kidney patients has been linked to a debilitating disorder known as Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NSD).

NSF/NSD is a rare disorder that causes thickening and hardening of the skin in patients with pre-existing kidney disease. NSF/NSD only affects about 215 people around the world, and the first cases were only reported in 1997. NSF/NSD is marked by high blood pressure, thickening of the skin, swelling of the skin around the joints, pain deep in the hip bones, muscle weakness and hardening of soft tissues. NSF/NSD can cause patients to loose mobility and it can lead to death. There is no cure for NSF/NSD, although improving kidney function can put the disease into remission. However, often the only way to accomplish this is through a kidney transplant.

Few studies have been done on NSF/NSD, but in 2006 a breakthrough did shine some light on this devastating disease. That year, a study conducted by the Danish Medicines Agency found that of 9 NSF/NSD patients, 5 experienced the onset of symptoms after they had undergone MRIs that involved the use of gadolinium based contrast agents. A few other studies soon reached similar conclusions, and by December 2006, 90 patients with moderate to end-stage kidney disease were known to have developed NSF/NFD after they had an MRA with a gadolinium based contrast agent.

In 2006, the FDA warned health care professionals about the link between gadolinium contrast agents and the occurrence of NSF/NSD. Then in 2007, the FDA requested that that the manufacturers of gadolinium based contrast agents update their products’ labels to include a black box warning regarding the risk of NSF/NSD in patients with kidney problems. The FDA also started a monitoring program to track the frequency of NSF/NSD related to gadolinium contrast agents.