GBCAs to include warning on NSF risk

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

GBCAs are intravenous drugs approved by FDA for use with magnetic resonance imaging or magnetic resonance 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 can include scaling, hardening and tightening of the skin, red or dark patches on the skin, and stiffness. NSF may be fatal, especially if it involves body organs.

Three GBCAs-gadopentetate dimeglumine (Magnevist, Bayer Healthcare) injection; gadodiamide (Omniscan, GE Healthcare) injection; and gadoversetamide (Optimark, Covidien) injection-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, according to FDA. Data suggest that NSF may follow the administration of any GBCA, and FDA continues to assess the safety of each GBCA to better estimate its NSF risks.

To further enhance the safe use of the imaging agents, FDA recommends that healthcare practitioners:

* Estimate kidney function through laboratory testing for patients at risk for chronically reduced kidney function. * Avoid use of GBCAs in patients suspected or known to have impaired drug elimination unless the imaging is essential and not available without contrast.

* Monitor for signs and symptoms of NSF if a GBCA is administered to a patient with acute kidney injury or chronic, severe kidney disease.

* Administer a GBCA only once during an imaging session.