Bottom Line, at the Top
No, Copaxone is not being discontinued but now carries a stronger safety warning. Patients should continue treatment as prescribed while staying informed and vigilant about potential side effects. If you have concerns, discuss them with your doctor.
When and What: Copaxone FDA Boxed Warning Edition
As you may have already heard; On January 22, 2025, the U.S. Food and Drug Administration (FDA) issued a safety update concerning glatiramer acetate, a medication primarily marketed under the brand name Copaxone and its generic counterpart, Glatopa.
What This Means for Patients
- Copaxone remains an FDA-approved treatment for relapsing forms of multiple sclerosis (MS).
- Patients can still use the medication but should be aware of the warning and monitor for signs of anaphylaxis (such as wheezing, swelling, or difficulty breathing).
- If you are currently on Copaxone, do not stop treatment without first consulting your doctor.
- Patients who experience a severe allergic reaction should seek emergency medical attention and discontinue use until further guidance from a healthcare professional.
The FDA’s Boxed Warning
A boxed warning is the FDA’s most prominent caution. It is used for highlighting the risk of a rare but serious allergic reaction known as anaphylaxis associated with this drug.
Why: The Reason Copaxone and Glatopa Have a New FDA Boxed Warning
The FDA’s decision to implement a Boxed Warning stems from the identification of 82 worldwide cases of anaphylaxis linked to glatiramer acetate use between December 1996 and May 2024. Notably, 19 of these cases occurred more than a year after the initiation of treatment. The majority of anaphylactic reactions manifested within one hour following injection, with symptoms ranging from wheezing and difficulty breathing to swelling of the face, lips, or throat, and hives. In severe instances, these reactions progressed to life-threatening conditions, including severe rash or shock, necessitating emergency medical intervention. Tragically, six fatalities have been reported in connection with these reactions.
What: Anaphylaxis Explained
Anaphylaxis may be more commonly referred to as an allergic reaction. It is the process the body goes through after exposure to something the typical immune system wouldn’t reject. To put it into context; When someone who is allergic to peanuts is exposed to the nut or its byproducts, they experience anaphylaxis as swelling of the throat and/or closure of airways. This is just one of many symptoms of anaphylaxis.
How: What Makes Copaxone Cause Anaphylaxis?
Copaxone (glatiramer acetate, Glatopa) is an immune-modulating drug used to treat multiple sclerosis (MS). While its exact mechanism is not fully understood, it works by altering immune system activity to reduce MS relapses. However, in some individuals, the immune system mistakenly identifies Copaxone as a harmful substance, triggering an extreme allergic response—anaphylaxis.
Potential Causes of Anaphylaxis with Copaxone
- Immune Sensitization:
- Over time, the immune system may develop hypersensitivity to Copaxone or its inactive ingredients.
- This can lead to a sudden allergic reaction after an injection, even if previous doses were well tolerated.
- Injection-Related Immune Response:
- Since Copaxone is injected subcutaneously (under the skin), the immune system may perceive it as a foreign invader, leading to a systemic allergic reaction.
- Protein Structure of the Drug:
- Copaxone is a mixture of synthetic peptides that resemble myelin basic protein, a component of nerve insulation.
- Some individuals may develop antibodies against the drug, triggering anaphylaxis.
- Pre-existing Allergies or Sensitivities:
- Patients with a history of severe allergic reactions or multiple drug allergies may be at a higher risk of developing anaphylaxis from Copaxone.
How to Respond to Anaphylaxis:
- Seek immediate emergency medical help (Call 911).
- Use an epinephrine auto-injector (EpiPen) if available and prescribed by a doctor.
- Stop using Copaxone and consult a healthcare provider before resuming treatment.
Distinguishing Anaphylaxis from Immediate Post-Injection Reactions
It’s important to differentiate between anaphylaxis and a more common, less severe response known as the immediate post-injection reaction. The latter can occur shortly after injection and typically resolves on its own within 15 to 30 minutes without specific treatment. Symptoms may include flushing, chest pain, palpitations, anxiety, shortness of breath, rash, or hives. While these reactions are generally transient and self-limiting, anaphylaxis is rare but more severe, with symptoms that worsen over time and require immediate medical attention.
While anaphylaxis from Copaxone is rare, it is a serious and potentially fatal reaction. Patients should be aware of the symptoms and seek immediate medical attention if they experience signs of anaphylaxis after injection. To ask questions with a Registered Pharmacist or seek additional Copaxone info, see our Copaxone page here.
