The major manufacturers of gadolinium-based MRI contrast agents have sent a letter to healthcare professionals alerting them to the possible relationship between the agents and nephrogenic systemic fibrosis (NSF).
The letter was required by the U.S. Food and Drug Administration (FDA) as part of its "black box" warning on gadolinium contrast, issued in May 2007. The letter was dated September 12, 2007, and was signed by regulatory executives with GE Healthcare of Chalfont St. Giles, U.K.; Bayer HealthCare Pharmaceuticals of Montville, NJ; Bracco Diagnostics of Princeton, NJ; and Mallinckrodt of Hazelwood, MO.
The letter informs healthcare professionals of revisions to the prescribing information for Magnevist (Bayer), MultiHance (Bracco), Omniscan (GE), OptiMark (Mallinckrodt), and ProHance (Bracco) products; specifically, that postmarketing reports indicate that the products increase the risk of developing NSF in patients with acute or chronic severe renal insufficiency, and patients with renal dysfunction due to hepatorenal syndrome or in the perioperative liver transplantation period.
The letter said that the FDA has received reports of more than 250 cases of NSF developing after administration of gadolinium-based contrast agents. The packaging insert for all gadolinium-based contrast agents has been revised to include a boxed warning, and an update to the "warnings" section of the packaging, the letter states.
By AuntMinnie.com staff writers
October 1, 2007
Related Reading
MR experts take issue with FDA gadolinium warning, September 18, 2007
Noncontrast MR: The solution to the NSF problem? July 26, 2007
FDA asks for 'black box' warning for gadolinium contrast, May 23, 2007
Gadolinium: A 'necessary factor' in the development of NSF? March 27, 2007
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