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Association of Omniscan™ (Gadodiamide) and Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD) - GE Healthcare Canada

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Contact: Marketed Health Products Directorate (MHPD)

Public Communication
Health Canada Endorsed Important Safety Information on Omniscan™

March 12, 2007

Subject: Association of Nephrogenic Systemic Fibrosis /Nephrogenic Fibrosing Dermopathy (NSF/NFD) with the use of gadodiamide (Omniscan)

GE Healthcare, in consultation with Health Canada, wishes to highlight important safety information pertaining to gadodiamide (Omniscan™), a gadolinium-based contrast agent used during magnetic resonance imaging (MR). MR Imaging is a test that uses a magnetic field and pulses of radio wave energy to make pictures of organs in order to detect the presence of disease.

During the past five years, GE Healthcare has received 96 reports of a rare disease called Nephrogenic Systemic Fibrosis /Nephrogenic Fibrosing Dermopathy (NSF/NFD) following gadodiamide use. These cases have been reported in the United States, Europe and Asia.

NSF/NFD is a rare condition which has only been observed so far in patients with kidney disease. While most affected patients have advanced kidney disease, some patients with less severe renal disease have recently been reported. At present, there is no evidence that other patient groups are at risk of developing the condition. Due to NSF/NFD the skin becomes thickened, coarse and hard, which sometimes makes bending of the joints difficult. NSF/NFD may spread to other organs and even cause death.

GE Healthcare is concerned by the association between gadodiamide use and NSF/NFD and urges caution in using Omniscan™ in patients with kidney diseases. GE Healthcare is closely following reported cases and working with reporting hospitals and experts in the field to conduct a thorough investigation.

Patients with kidney disease who may be undergoing a MR Imaging diagnostic procedure should discuss with their health care professionals the benefits and risk associated with use of a gadolinium contrast agent. Those who have already had an MR imaging procedure and who have any of the following symptoms should seek medical attention as soon as possible:

• Swelling, hardening and tightening of the skin
• Reddened or darkened patches on the skin
• Burning or itching of the skin
• Yellow spots on the whites of the eyes
• Stiffness in the joints, problems moving or straightening arms, hands, legs or feet
• Pain deep in the hip bone or ribs
• Weakness of the muscles

GE Healthcare and Health Canada will work jointly to update the Canadian prescribing information for Omniscan™ in order to include this new information. GE Healthcare has provided this information to relevant health care professionals across Canada.

This advisory and letters issued to health care professionals can be accessed at Health Canada's website. For more information about Omniscan™, patients should consult their health care professional.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious NSF/NFD or other serious or unexpected adverse reactions should be reported to the appropriate manufacturer or Health Canada. Serious or unexpected adverse events in patients receiving Omniscan™ should be reported to GE Healthcare or Health Canada at the following addresses:

Sincerely,

original signed by

J. Sardi
Director General
GE Healthcare Canada