Gadolinium

MRI (magnetic resonance imaging) and MRA (magnetic resonance angiography) scans are invaluable diagnostic tools. An MRI uses magnets and radio wave pulses to map a patient’s body, millimeter by millimeter, creating a two- or three-dimensional model of organs and structures inside the body. A MRA is a type of MRI, but it is a specific MRI that focuses on capturing images of the blood vessels.

Before patients go for MRI and MRA scans, they are often injected with a dye used to help radiologists visualize soft tissues and distinguish the contrasting blood vessels. Gadolinium is found in the dyes used in some patients before an MRI or MRA scan. Gadolinium is a silvery-white metal whose paramagnetic properties make it useful in the imaging process.

However, gadolinium-based contrast agents have been linked to a rare, debilitating, and potentially fatal disease known as Nephrogenic Systemic Fibrosis, or NSF. NSF, also sometimes referred to as Nephrogenic Fibrosing Dermopathy (NFD), is a horrific condition in which scarring (fibrosis) or excess tissue forms in the skin and around internal organs, joints and muscles. Lawsuits have been filed as a result.

NSF symptoms include hard, itchy, swollen and shiny patches of red or darkened skin that tighten and become extremely painful. Joint flexibility is lost; joints swell and become painful; and the range of body movement is severely limited. There is deep pain in the hips and ribs. Muscles weaken. Eyes become yellowed. There may be lung, heart, and organ damage. Victims of NSF may become dependent upon a wheelchair within weeks of onset.

Patients who are most susceptible to NSF are those with compromised liver function, chronic liver disease or recent liver transplant, kidney damage or renal failure. Normally, contrast dyes are excreted in the hours following an MRI or MRA scan. In people with poorly functioning livers or kidneys, the dye is not adequately excreted, and gadolinium essentially poisons the body.

NSF was first recognized in the late 1990s and is only associated with the metallic agent gadolinium. Five gadolinium-based contrast agents have been approved for use in the United States: Magnevist (gadopentetate dimeglumine), Ominiscan (gadodiamide), OptiMARK (gadoversetamide), MultiHance (gadobenate dimeglumine), and ProHance (gadoteridol).

Since 2007, the Federal Food and Drug Administration (FDA) has required that manufacturers include a black box warning on the product labels of all gadolinium-based contrast agents. The warning must outline the risks of developing NSF in patients with certain liver and kidney conditions.

Lawsuits launched against the manufacturers of gadolinium contrast dyes allege that the manufacturers failed to research the impact of the product on people with impaired kidney or liver function. Further, the suits claim that the manufacturers did not properly warn the public about the possible adverse effects of the product.

Manufacturers named in the lawsuits include Bayer HealthCare Pharmaceuticals, Bracco Diagnostics, GE Healthcare, and Mallinckrodt.

There is no known treatment for NSF.

Bold labels are required.