MRI Gadolinium agents get strong “black box” warning
Gadolinium products used in MRIs will now carry the U.S. Food and Drug Administration's strongest, "black box" warning. The FDA's decision Friday Sep 28th finalizes its announcement made in May that it would add the labeling warning to the MRI contrast agents. The warning notes that gadolinium increases risk of a potentially fatal side effect in patients with kidney and liver conditions such as renal failure. The skin disease called nephrogenic systemic fibrosis, or NSF, can occur in some patients, the companies said in a joint letter to health-care professionals, posted on the FDA's Web site on Friday. The imaging agents are made by Bayer AG's Bayer Schering Pharma, General Electric Co's GE Healthcare, Tyco International Ltd.'s Mallinckrodt unit, and Bracco Diagnostics Inc. Agency officials first alerted doctors to the potential risk in 2006, following reports that patients who received the injectable agents developed NSF. Although the risk of NSF from any one agent is unknown, the letter cited a study that found an estimated risk in patients with severe renal insufficiency at 4 percent. Patients should be screened for kidney problems before use of such agents, the letter said, further adding that the recommended dose should not be exceeded.
