"Black Box" warning for Gadolinium Agents

Scott Kappes

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Last Friday the FDA completed the decision made a few months back to add a "black box" warning to all FDA approved gadolinium containing contrast agents, by issuing a "Dear Healthcare Professional" letter. These contrast agents are commonly used in conjunction with magnetic resonance imaging (MRI) to greatly enhance the image produced by the procedure. These contrast agents however have been linked to a rare life threatening skin disease called nephrogenic systemic fibrosis (NSF).

The letter sent out to healthcare professionals and posted to the FDA website on Friday tells of the dangers associated with certain patients and the use of these agents. Patients with moderate to severe kidney failure and certain liver conditions are at risk for developing the debilitating disease. NSF is characterized by the thickening of the skin, tissue, and internal organs and can lead to increased difficulty in movement and even death.

A study claims that the risk of developing this disease after being injected with gadolinium-based agents is 4 percent in patients with severe renal failure. There have been no reports of this disease being linked to patients with normal or moderate kidney function. There has been little success treating the condition and there is no cure. Hopefully the new warning will shield potential patients from this dangerous disease.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.