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Health Canada Health products

Risk of anaphylactic reaction associated with glatiramer acetate, used to treat multiple sclerosis

Issued August 21, 2025
Issue
Health Canada is warning patients that they may experience anaphylactic reactions after receiving glatiramer acetate, which is used to treat relapsing-remitting multiple sclerosis. These anaphylactic reactions can be fatal and may occur at any point during treatment, from as soon as the first dose to months or even years after starting therapy. Anaphylactic reaction symptoms generally appear within one hour of injection and may include: Sudden shortness of breath, wheezing, or difficulty breathing Swelling of the eyelids, face, lips, mouth, tongue, or throat Uncontrolled shaking Fainting or dizziness Trouble swallowing or speaking Widespread rash, hives Collapse Health Canada confirmed this new safety risk following a review of all available data, including 11 Canadian cases of anaphylactic reactions from Copaxone and three additional cases from other glatiramer acetate products. While there have been no fatal cases reported in Canada, some cases required treatment with epinephrine and other appropriate medical interventions. There have been fatal cases reported internationally. Health Canada has informed healthcare professionals , including neurologists, emergency room physicians and staff, nurses, and pharmacists about this new safety risk. The manufacturer for Copaxone has updated its Canadian product labelling to include this risk, and Health Canada is working with the manufacturers of other glatiramer acetate products — including Glatect and Mylan glatiramer acetate injection — to update their respective labelling.
Hazard description
Product safety - New safety information
What to do
If you experience anaphylactic reaction symptoms, stop taking glatiramer acetate and seek immediate medical help by calling 9-1-1. Do not restart taking glatiramer acetate if you have experienced anaphylaxis unless your healthcare provider has identified another clear cause for the anaphylaxis. Report any health product-related side effects to Health Canada.
Product
Product name
Glatiramer acetate
Reference
ID
RA-77939