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Copaxone (glatiramer acetate), Glatect (glatiramer acetate), Mylan glatiramer...

# Major Recall Alert: Copaxone (Glatiramer Acetate), Glatect, and Mylan Glatiramer Acetate Injection Recalled Due to Risk of Fatal Anaphylactic Reactions

Health Canada has issued a critical safety alert regarding glatiramer acetate products used to treat relapsing-remitting multiple sclerosis (RRMS). This includes **Copaxone**, **Glatect**, and **Mylan glatiramer acetate injection**, following confirmed reports of potentially fatal anaphylactic reactions.

Anaphylaxis can occur at any point during treatment – from the very first dose to several years into therapy. Patients who rely on these medications must stay informed about the symptoms and their risks. Read on for full details about the recall and what steps you should take to stay safe.

## Why This Recall is Important

Glatiramer acetate products, including Copaxone and its generics, are widely prescribed to manage relapsing-remitting multiple sclerosis. However, a new review by Health Canada uncovered **serious safety concerns**, including:

- 11 Canadian cases of severe **anaphylactic reactions** tied to Copaxone.
- 3 additional cases linked to other glatiramer acetate products from other manufacturers.
- Several international incidents, including fatal cases.

Although no fatalities have been reported in Canada yet, treatment with emergency interventions (such as epinephrine) was required in some of the reported cases. To protect the health of Canadians, Health Canada is ensuring all manufacturers update their product labelling to reflect this new risk.

### What is Anaphylaxis?

Anaphylaxis is a life-threatening allergic reaction that can occur suddenly – usually within an hour of receiving an injection. Key symptoms include:

- **Sudden difficulty breathing**: wheezing, shortness of breath, or choking.
- **Swelling**: particularly of the eyelids, lips, tongue, face, or throat.
- **Uncontrolled shaking or fainting**: fatigue or dizziness.
- **Trouble speaking or swallowing**: accompanied by a choking sensation.
- **Skin symptoms**: widespread rash, hives, or redness.
- **Collapse**: losing consciousness.

If you experience any of the above symptoms after receiving glatiramer acetate injections, seek immediate medical attention.

## Details of the Recall

- **Products Affected**:
- **Copaxone (glatiramer acetate)**
- **Glatect (glatiramer acetate)**
- **Mylan glatiramer acetate injection**

- **Reason**: Increased risk of severe anaphylactic reactions that could be life-threatening.

- **Announcement Date**: October 2023.

- **Action Taken**:
- Manufacturers are updating product labelling to include anaphylaxis as a known safety risk.
- Healthcare professionals, including neurologists, nurses, and pharmacists, have been informed of these risks to ensure early recognition and treatment.

For further details, visit the official recall page from Health Canada: [Anaphylactic Reaction Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/risk-anaphylactic-reaction-associated-glatiramer-acetate-used-treat-multiple-sclerosis).

## What You Should Do

Health Canada is urging patients and healthcare providers to take the following precautions:

- **For Patients**:
- Be aware of the symptoms of anaphylactic reactions.
- Always have a treatment plan in place with your healthcare provider.
- Seek emergency care immediately if symptoms of anaphylaxis occur.

- **For Healthcare Professionals**:
- Monitor patients closely after administering glatiramer acetate injections.
- Educate patients on the risks and warning signs.
- Be prepared to administer emergency interventions, including epinephrine if needed.

If you have concerns about continuing treatment, consult your prescribing doctor before making any changes.

## Stay Safe – Get Instant Recall Alerts

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For official updates on the Copaxone recall, visit Health Canada: [Health Canada Recall Notice](https://recalls-rappels.canada.ca/en/alert-recall/risk-anaphylactic-reaction-associated-glatiramer-acetate-used-treat-multiple-sclerosis)

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