Health Canada

Health Canada

November 14, 2013 15:59 ET

Updated Safety Information for Gadolinium-Based Contrast Agents

OTTAWA, ONTARIO--(Marketwired - Nov. 14, 2013) - Health Canada is informing Canadians that certain gadolinium-based contrast agents may have a higher risk than others for a rare but serious skin disease in patients with kidney problems.

Gadolinium-based contrast agents (GBCAs) are administered by injection and are used to enhance images from magnetic resonance imaging (MRI) scans. Gadolinium is eliminated from the body through the kidneys. The use of GBCAs has been linked to a rare and potentially fatal skin disease, Nephrogenic Systemic Fibrosis, in patients with various types of kidney problems. Health Canada has communicated on the risk of this skin disease in the past and the labelling information of GBCAs contains clear warnings related to the potential for this disease in patients with kidney problems.

Nephrogenic Systemic Fibrosis (NSF) 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, which can be fatal.

While NSF is a known risk for all gadolinium-based contrast agents, current evidence suggests that the degree of this risk may vary depending on the agent used. Specifically, Magnevist, Omniscan and OptiMARK have been linked with a higher risk of NSF relative to other GBCAs (Ablavar, Gadovist, MultiHance, Primovist and ProHance). Evidence also suggests that, regardless of the GBCA used, the risk of NSF may be increased by factors such as dose, how often it is given, and for how long.

Based on these observations, labels for Magnevist, Omniscan and OptiMARK have been updated to warn that these agents are not to be used in patients with severe kidney problems or in newborns under four weeks old, as their kidneys are not yet sufficiently developed. The other GBCAs should be used with extreme caution in these patients - i.e., their use should be avoided unless the diagnostic information they provide is absolutely essential.

Health Canada has worked with the Canadian companies who manufacture GBCAs to update prescribing information. Health Canada has sent a Notice to Hospitals to inform healthcare professionals of the new restrictions for patient selection and instructions for use of gadolinium-based contrast agents.

What you should do

  • Patients with kidney disease should talk to their healthcare professional about any questions or concerns, including the availability of lower-risk options and whether the use of a gadolinium-based contrast agent is essential with their MRI scan.
  • Seek medical attention right away after receiving a gadolinium-based contrast agent if you have any of these symptoms, which may be a sign of Nephrogenic Systemic Fibrosis :
    • burning, itching, swelling, hardening, or tightening of the skin, or reddened or darkened skin patches
    • yellow spots on the whites of the eyes
    • joint stiffness or problems moving or straightening arms, hands, legs or feet
    • muscle weakness
    • pain deep in the hip bone or ribs

Report health or safety concerns

To report a side effect to a health product to Health Canada:

- Call toll-free at 1-866-234-2345

- Visit MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax

Related Advisories, Warnings and Recalls

- November 14, 2013 - Update on Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy (NSF/NFD) associated with the Use of Gadolinium-Containing Contrast Agents - Notice to Hospitals

- January 12, 2010 - OPTIMARK (gadoversetamide injection) - Association with Nephrogenic Systemic Fibrosis (NSF) in Patients with Renal Impairment - For the Public -For Health Professionals

- October 2007 Canadian Adverse Reaction Newsletter: Gadolinium-containing agents: update on nephrogenic systemic fibrosis

- March 13, 2007 - Notice to Hospitals - Association of gadolinium-containing contrast agents and Nephrogenic Systemic Fibrosis /Nephrogenic Fibrosing Dermopathy (NSF/NFD)

- March 13, 2007 - Health Canada advises Canadians of safety issues related to gadolinium-containing contrast agents used in magnetic resonance imaging (MRI)

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