Home/Recalls/CANADA-77939
Health CanadaGeneral Alert

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

Published: August 21, 2025Recall ID: 77939Category: generalCountry: Canada

Reason for Recall / Hazard

Product safety - New safety information

Product Description & Identification

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 doInform 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.

Affected Products

Glatiramer acetate

Additional Source Details

FieldValue
N I D77939
U R Lhttps://recalls-rappels.canada.ca/en/alert-recall/risk-anaphylactic-reaction-associated-glatiramer-acetate-used-treat-multiple-sclerosis
IssueProduct safety - New safety information
TitleRisk of anaphylactic reaction associated with glatiramer acetate, used to treat multiple sclerosis
ProductGlatiramer acetate
Archived0
CategoryDrugs
Last updated2025-08-21
OrganizationCommunications and Public Affairs Branch
What you should doIf 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 doInform 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.

Overview

  • Recalling FirmCommunications and Public Affairs Branch
Official Agency Alert