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



    OTTAWA, March 13 /CNW Telbec/ - 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
(www.medeffect.gc.ca) portal of the Health Canada Web site.

    Egalement disponible en français




For further information:

For further information: Media Inquiries: Alastair Sinclair, Health
Canada, (613) 957-1803; Public Inquiries: (613) 957-2991, 1-866-225-0709


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