The request on Tuesday by the FDA to have manufacturers include a new boxed warning on the label of these products is due to the potentially fatal disease (nephrogenic systemic fibrosis [NSF]) that this contrast agent can cause in the patient with severe kidney insufficiency.
Kidney transplant patients (both before and after transplantation) and chronic liver disease patients who are experiencing kidney insufficiencies are also at risk of developing NSF if they receive this contrast agent with an MRI.
"[The] FDA has been carefully monitoring potential safety signals related to these contrast agents after receiving reports about the risk of this potentially life-threatening disease," said Steven Galson, M.D., M.P.H., director of the FDA's Center for Drug Evaluation and Research.
Although the FDA made their initial announcement notifying the healthcare industry and the public about these risks in June 2006, the request for "boxed warning labels" is now being requested of manufacturers to further prevent potential safety issues.
Dr. Galson states, "This latest action demonstrates FDA's continuing vigilance about ensuring the safety of drug products once they enter the marketplace."
