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New Warnings for Imaging Agent
by admin on: January 4th, 2012

September 2010 – the U.S Food and Drug Administration (FDA) has issued a statement saying that gadolinium-based contrasting agents (GBCAs) must display new warnings on their labels. These new warnings state that use of these products carries a risk of nephrogenic systemic fibrosis (NSF), which is a rare condition that is potentially fatal. The data, while not totally conclusive, is strong enough to indicate that NSF may result following the administration of any GBCAs. The FDA has previously approved a total of five GBSCAs; however, three GBCAs in particular ??? Magnevist, Omniscan and Optimark ??? have been determined to be inappropriate for patients that have been diagnosed with either chronic kidney disease or acute kidney injury.

While the cause of NSF remains unknown, this condition results in the formation of excess fibrous tissue. This excess tissue can affect the eyes, internal organs, joints, and skin. Some examples of reported symptoms of NSF include a hardening and tightening of skin, the appearance of dark or red patches, and scaling skin. Generally speaking, NSF starts affecting the body by attacking the lower extremities. Over time, NSF can result in fibrosis developing in the diaphragm as well as some of the muscles in the thighs and lower abdomen. The effects of fibrosis may also affect the vessels in the lung. To date, there is no treatment for NSF.

On the FDA website, gadolinium is described as being a paramagnetic ion, which have a tendency to move differently when exposed to magnetic fields. Because of this characteristic, gadolinium is useful for providing images of body, organs, and tissues made with magnetic resonance imaging ??? more commonly referred to as MRI. In addition, GBCAs are also useful for a special type of MRI called magnetic resonance angiography (MRA) which is an imaging process that allows evaluation of particular blood vessels.

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