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

OTTAWA, ON, Aug. 21, 2025 /CNW/ -

Summary

• Product: Glatiramer acetate
• Issue: Health products – 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. Report any health product-related side effects to Health Canada. Do not restart taking glatiramer acetate unless your healthcare provider has identified another clear cause for the anaphylaxis.

Affected products

Product	Dose
Copaxone (glatiramer acetate)	20 mg/mL	single-use pre-filled syringe
Copaxone (glatiramer acetate)	40 mg/mL	single-use pre-filled syringe
Copaxone (glatiramer acetate)	40 mg/mL	single-use pre-filled pens
Glatect (glatiramer acetate)	20 mg/mL	single-use pre-filled syringe
Mylan glatiramer acetate injection	20 mg/mL	single-use pre-filled syringe

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.

What you should 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.

What healthcare professionals should do

• Inform patients and/or caregivers of the signs and symptoms of anaphylactic reactions, which may overlap with those of an immediate post-injection reaction.
• Instruct patients to seek immediate emergency medical care in the event of an anaphylactic reaction.
• Instruct patients to discontinue treatment with glatiramer acetate if they have an anaphylactic reaction.
• Do not restart the medicine unless there is another clear reason the patient experienced an anaphylactic reaction.

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SOURCE Health Canada (HC)

Media Enquiries: Health Canada, [phone], [email protected]; Public Enquiries: [phone], 866 225-0709, [email protected]