May 23, 2007—Gadolinium-based contrast agents now must carry a black box warning due to the risk of a potentially fatal disease.
Patients with kidney disease or chronic liver disease risk developing nephrogenic systemic fibrosis. This disease is characterized by the thickening of skin and connective tissues, inhibiting a person's ability to move. Nephrogenic systemic fibrosis can be fatal.
The FDA first warned medical providers of a link between gadolinium-based agents and nephrogenic systemic fibrosis in June 2006. The warning was updated in December 2006.
The agency stated it was aware of at least 128 reports of nephrogenic systemic fibrosis in patients who were administered a gadolinium-based contrast agent. |