The advisory notes that there have been 109 cases worldwide of patients contracting nephrogenic systemic fibrosis/nephrogenic fibrosing dermopathy (NSF/NFD) following gadolinium administration. While no cases of NSF/NFD have occurred in Canada, the agency said that seven gadolinium-based agents are sold in the country: Omniscan (GE Healthcare, Chalfont St. Giles, U.K.), Magnevist (Bayer Schering Pharma, Berlin), Optimark (Mallinckrodt, Hazelwood, MO), Gadovist (Bayer Schering Pharma), ProHance (Bracco Diagnostics, Princeton, NJ), MultiHance (Bracco), and Vasovist (Epix Pharmaceuticals, Cambridge, MA).
Health Canada will be working with the marketing authorization holders of the agents to update their product information. The agency recommends that patients with serious kidney disease "consult their healthcare professionals regarding their individual needs in order to minimize the risk of developing NSF/NFD following an imaging procedure."
Healthcare providers can report product-related adverse reactions to Health Canada by telephone at 1-866-234-2345, or on the agency's Web site at www.medeffect.gc.ca.
By AuntMinnie.com staff writers
March 15, 2007
Scottish study shows potential gadolinium-NSF link, March 9, 2007
Gadolinium-based contrast may cause nephrogenic systemic fibrosis, March 6, 2007
ACR releases new MR safety guidelines, March 1, 2007
FDA learns of more cases of gadolinium-related disease, December 26, 2006
Link between gadolinium exposure and skin disease strengthened, November 22, 2006
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