Recalls and alerts more than 4 years old are automatically archived. While this information can still be accessed in the database, it has not been altered or updated since it was archived. Web pages that are archived on the Web are not subject to the Government of Canada Web Standards. As per the Communications Policy of the Government of Canada, you can request alternate formats by contacting us.

Archived – Health Canada advises Canadians of safety issues related to gadolinium-containing contrast agents used in magnetic resonance imaging (MRI)

Starting date:
March 13, 2007
Posting date:
March 13, 2007
Type of communication:
Advisory
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public
Identification number:
RA-110001873

Health Canada is advising consumers of a notice sent to Canadian hospitals advising relevant health care professionals of safety concerns related to contrast agents containing gadolinium. These contrast agents have been linked to a rare and potentially fatal skin disease that sometimes affects other organs.

A contrast agent is a liquid that is injected into the body to make certain tissues more visible during imaging procedures. Contrast agents containing gadolinium are most often used during magnetic resonance imaging (MRI). The disease linked to gadolinium-containing contrast agents is called Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD).

To date, 109 cases of NSF/NFD associated with gadolinium-containing contrast agents have been reported worldwide. There are no reported cases of NSF/NFD in Canada. So far, NSF/NFD has only been observed in patients with serious kidney disease. The seven gadolinium-containing contrast agents authorized for sale in Canada are Omniscan, Magnevist, Optimark, Gadovist, ProHance, MultiHance, and Vasovist.

NSF/NFD may develop over a period of a few days to several weeks. The most visible effect is lesions on the skin. Affected skin becomes thickened with a woody texture, restricting joint movement and resulting in the shortening or distortion of muscle tissue. Internal organs such as the heart may also be affected. A skin biopsy is necessary to accurately diagnose this disease.

Health Canada will be working with the marketing authorization holders of the gadolinium-containing contrast agents authorized for sale in Canada to update the product information for these agents.

Health Canada recommends that patients with serious kidney disease consult their health care professionals regarding their individual needs in order to minimize the risk of developing NSF/NFD following an imaging procedure.

Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. To report a suspected adverse reaction to these or any other health products, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:

Telephone: 1-866-234-2345
Facsimile: 1-866-678-6789

CADRMP
Marketed Health Products Directorate
Tunney's Pasture, AL 0701C
email: cadrmp@hc-sc.gc.ca

The CADRMP adverse reaction reporting form, including a version that can be completed and submitted online, is located on the MedEffect portal of the Health Canada Web site.


Media enquiries

Alastair Sinclair
Health Canada
(613) 957-1803

Public enquiries

(613) 957-2991
1-866 225-0709