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

Starting date:

March 12, 2007

Posting date:

March 13, 2007

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000571

• Related AWRs

This is duplicated text of a letter from GE Healthcare Canada.
Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

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.

• There are ninety six cases of NSF/NFD reported worldwide following the injection of gadodiamide (Omniscan™).
• NSF/NFD is a rare but serious condition which has only been observed in patients with kidney disease.
• There are no Canadian cases of NSF/NFD reported at this time.

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:

GE Healthcare Canada Inc.
2300 Meadowvale Blvd
Mississauga, Ontario, L5N 5P9
Tel: 1-800-367-2773 or Fax: (905) 847-5849

Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
Health Canada
Address Locator: 0701C
Ottawa, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
cadrmp@hc-sc.gc.ca

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: MHPD_DPSC@hc-sc.gc.ca
Tel: (613) 954-6522
Fax: (613) 952-7738

Sincerely,

original signed by

J. Sardi
Director General
GE Healthcare Canada

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