New Warnings Issued on Use of Gadolinium-Based Contrast Agents

Officials are requiring that gadolinium-based contrast agents (GBCAs) carry new warnings on their labels about the risk of a rare and potentially fatal disorder known as nephrogenic systemic fibrosis (NSF), if the drug is administered to certain patients with kidney disease.

Three of the GBCAs--Magnevist, Omniscan, and Optimark--will be described as inappropriate for use among patients with acute kidney injury or chronic severe kidney disease. All GBCA labels will emphasize the need to screen patients to detect these types of kidney dysfunction before administration. GBCAs are intravenous drugs approved by the U.S. Food and Drug administration (FDA; Silver Spring, MD, USA) for use with magnetic resonance imaging (MRI) or MR angiography to help detect abnormalities of body organs, blood vessels, and other tissues.

NSF is a condition involving the formation of excess fibrous connective tissue in the skin, joints, eyes, and internal organs. Symptoms of NSF can include scaling, hardening, and tightening of the skin, red or dark patches on the skin, and stiffness. NSF may lead to death, especially if it involves body organs.

The FDA's review of the safety of the most widely used GBCAs determined that Magnevist, Omniscan, and Optimark are linked with a greater risk than other GBCAs for NSF in specific patients with kidney disease. Data suggest that NSF may follow the administration of any GBCA and the FDA continues to evaluate the safety of each GBCA to better estimate its NSF risks. "The FDA is requiring these labeling changes to enhance the safe use of gadolinium-based contrast agents, including avoidance of certain agents among patients at highest risk for nephrogenic systemic fibrosis,” said Rafel Rieves, M.D., director of the Division of Medical Imaging Products in the FDA's Center for Drug Evaluation and Research.

To further enhance the safe use of the imaging agents, the FDA recommends that health care professionals to estimate kidney function through laboratory testing for patients at risk for chronically reduced kidney function; to avoid use of GBCAs in patients suspected or known to have impaired drug elimination unless the imaging is essential and not available without contrast; to monitor for signs and symptoms of NSF if a GBCA is administered to a patient with acute kidney injury or chronic, severe kidney disease; and to administer a GBCA only once during an imaging session.

Magnevist is marketed by Bayer Healthcare (Leverkusen, Germany), Omniscan by GE Healthcare (Chalfont St. Giles, UK), and Optimark by Covidien (Mansfield, MA, USA).

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