Copaxone and its generic counterpart, Glatopa, have been associated with severe allergic reactions, even in patients who have been using the medication for months without any prior issues.
Key Highlights:
- The FDA has issued a warning that the multiple sclerosis (MS) medications Copaxone and its generic version, Glatopa (glatiramer acetate), may cause rare but life-threatening allergic reactions.
- These injectable treatments have been linked to anaphylactic shock, a severe reaction that can impair or completely stop breathing.
- Patients experiencing symptoms such as wheezing, difficulty breathing, or swelling of the face, lips, or throat should seek immediate medical attention.
The U.S. Food and Drug Administration (FDA) has issued a strong warning regarding the multiple sclerosis (MS) drug Copaxone (glatiramer acetate) and its generic equivalent, Glatopa, due to rare but potentially life-threatening allergic reactions. The agency has added a “black box” warning, its most severe alert, to these medications to highlight the risk of anaphylaxis, a severe allergic reaction that can be fatal if not treated promptly.
According to the FDA, since Copaxone’s initial approval in 1996, 82 cases of anaphylaxis linked to the drug have been reported globally. These reactions were severe enough to require emergency medical intervention or hospitalization, and tragically, six individuals have died. While these numbers may seem small compared to the estimated 32,000 U.S. patients taking the drug annually, the FDA stresses that anaphylaxis can occur unpredictably, even after long-term use without prior adverse effects.
Jeffrey Cohen, MD, a neurologist at the Mellen Center for Multiple Sclerosis at the Cleveland Clinic, underscored the seriousness of this risk. “Anaphylaxis associated with glatiramer acetate is a very rare but potentially life-threatening adverse effect, and anaphylaxis can occur at any time after initiating therapy,” he explained.
How Do You Know if You’re Having a Severe Allergic Reaction?
For individuals taking Copaxone or Glatopa, recognizing the early signs of anaphylaxis is crucial. If a patient experiences symptoms such as wheezing, difficulty breathing, swelling of the face, lips, or throat, or hives, they should seek emergency medical care immediately by calling 911 or heading to the nearest hospital.
Most of the reported anaphylactic reactions occurred within one hour of injection, according to the FDA. However, in some cases, symptoms developed later, making it essential for patients to remain vigilant even after the initial administration.
Additionally, the FDA warns that early symptoms of anaphylaxis may resemble common, short-lived side effects that many patients experience shortly after injecting Copaxone or Glatopa. These include:
- Flushing or sudden warmth
- Chest pain
- Rapid heartbeat
- Anxiety
- Shortness of breath or tightness in the throat
- Skin reactions such as rash, hives, or itching
While these side effects typically resolve within 15 to 30 minutes, the agency advises that if symptoms persist or worsen, patients should seek emergency medical attention to rule out a severe allergic reaction.
Severe Allergic Reactions Can Occur at Any Point During Treatment
One of the most concerning aspects of this warning is that anaphylaxis can develop at any time, even in patients who have been taking the drug for months or years without previous issues.
The FDA identified 19 patients who suffered anaphylaxis after more than a year of using the medication, demonstrating that long-term use does not eliminate the risk. Conversely, one patient tragically suffered anaphylactic shock and died after just a single dose, emphasizing that the reaction is unpredictable.
Patients who experience any signs of anaphylaxis should discontinue the medication immediately and never take it again, as repeat exposure could lead to a more severe or fatal reaction. For those with milder side effects, stopping treatment temporarily and consulting a healthcare provider is strongly advised before resuming injections.
What Should Patients Do?
The FDA’s latest warning reinforces the importance of monitoring post-injection symptoms carefully. While Copaxone and Glatopa remain widely prescribed and effective treatments for MS, patients should be aware of the risks and act swiftly at any sign of an allergic reaction.
If a patient experiences difficulty breathing, swelling, or other potential signs of anaphylaxis, immediate medical intervention is critical. Those who have had a severe reaction in the past should avoid glatiramer acetate altogether and discuss alternative treatment options with their doctor.
While the risk of anaphylaxis is rare, this updated guidance aims to ensure that patients, caregivers, and healthcare providers remain vigilant to prevent avoidable medical emergencies.