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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:
- Medical Device
- Source of recall:
- Health Canada
- Product Safety
- General Public
- Identification number:
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:
Marketed Health Products Directorate
Tunney's Pasture, AL 0701C
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.
- Date modified: