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Health Canada Issues Anaphylaxis Warning for MS Drug
The federal agency noted more than a dozen allergic reactions to glatiramer acetate.

September 3, 2025 by Laurie Watanabe

Health Canada has issued a public advisory about glatiramer acetate, used to treat relapsing-remitting multiple sclerosis (MS).

The agency warned on Aug. 21 that patients taking glatiramer acetate could experience anaphylactic reactions, which “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.”

Health Canada said it knows about 11 cases of anaphylactic reactions from Copaxone, a brand name for glatiramer acetate, plus three more cases from other glatiramer acetate products. Some cases “required treatment with epinephrine and other appropriate medical interventions,” but none of the Canadian cases were fatal.

The glatiramer acetate products involved are 20 mg/mL or 40 mg/ML of the medication, packaged in single-use, pre-filled syringes.

Health Canada is the federal institution “responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible, and works to reduce health risks.”

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