Gadolinium Based Contrast Agent – Magnevist

Magnevist was the first Gadolinium based contrast agent approved for use in the United States by the US Food and Drug Administration. Introduced in 1988, the contrast agent has been used in more than 80 million applications worldwide. As the first contrast agent approved for use in enhancing MRI images, Magnevist is still considered an industry leader in its field. Magnevist is used in a wide variety of clinical applications including the imaging of the head, neck, body, and the central nervous system and is approved for use in both adults and children. The contrast agent is available in over 100 countries and is the most studied MRI contrast agent with over 14,000 medical references and citations in scientific literature.

Magnevist is manufactured by Berlex Inc. based in Wayne, New Jersey. Also known as Gadopentetate dimeglumine, it is produced as an injectable solution that is used to assist in the diagnosis of a variety of medical conditions. Magnevist enhances images taken with an MRI and highlights problem areas such as abnormal growths or tumors. The solution is injected directly into the vein prior to undergoing an MRI and the contrast agent is removed from the body by the kidneys.

Common side effects associated with the use of Magnevist includes headache, nausea, vomiting, and an altered taste in the mouth. These side effects are generally mild and occur in a small number of patients. More serious side effects include chest pain, dizziness, flushing, localized discomfort at the site of the injection, and excessive sweating. Rarely, a severe allergic reaction can occur characterized by difficulty breathing, the appearance of a skin rash or hives, and intense itching sensations. An allergic reaction to the solution requires urgent medical treatment avoid serious, life-threatening complications. Serious adverse event associated with Magnevist are considered rare.

Clinical studies conducted recently have discovered a link between Gadolinium based contrast agents such as Magnevist and the development of a severe, occasionally fatal condition called Nephrogenic Systemic Fibrosis. This condition is characterized by the appearance of darkened or reddened patches on the skin that start to thicken and tighten, causing severe discomfort and debilitating pain. As the skin tightens, it begins to impair movement and causes muscles to weaken and atrophy. In severe cases, the movements become so restricted that attempting movement can break bones. Many patient suffering from Nephrogenic Systemic Fibrosis become confined to a wheelchair or become bedridden.

There is no cure available for Nephrogenic Systemic Fibrosis. Many of the treatment options recommended for the relief of the symptoms are ineffective. The disorder only occurs in patients with moderate to advanced kidney disease and those with kidney failure that have received an injection of a Gadolinium based contrast agent prior to undergoing an MRI. Nephrogenic Systemic Fibrosis is considered a rare condition with less than 300 cases confirmed worldwide. Although it is not confirmed that Gadolinium based contrast agents are responsible for the development of Nephrogenic Systemic Fibrosis, the association is strong enough to warrant a public health advisory issued by the US Food and Drug Administration warning of the increased risk.