Gadolinium Lawyer

The U.S. Food and Drug Administration (FDA) have asked manufacturers of all gadolinium-based contrast agents to include a new boxed warning on the product labeling. These agents are used to enhance the quality of magnetic resonance imaging (MRI).The warning states that patients with severe kidney insufficiency are at risk for developing a debilitating, and a potentially fatal disease known as nephrogenic systemic fibrosis (NSF) if they receive gadolinium-based agents. In addition, the warning would also state that another group of patients at risk for developing NSF as those patients with chronic liver disease and patients just before or just after liver transplantation. “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 FDA’s Center for Drug Evaluation and Research. “This latest action demonstrates FDA’s continuing vigilance about ensuring the safety of drug products once they enter the marketplace.” Patients with NSF develop thickening of the connective tissues and skin and that inhibits their ability to move and may result in broken bones. Other organs are also at risk of thickening. The cause of NSF is not known and there is no consistently effective treatment for this condition.

To learn more, contact the Gadolinium lawyers at Williams Kherkher by calling 1.800.220.9341.