FDA Adds Boxed Warning to Glatiramer Acetate Over Risk of Rare, Serious Allergic Reaction

The FDA added a boxed warning about the risk of anaphylaxis with use of glatiramer acetate (Copaxone; Teva Neuroscience Inc) and it's generic, Glatopa (Sandoz Inc), a treatment for patients with multiple sclerosis (MS). This allergic reaction can happen at any time during treatment, underscoring the critical need for comprehensive, effective symptom monitoring.

Syringes with glatiramer acetate, Copaxone | Image Credit: © Andrew Barker - stock.adobe.com

The addition of the boxed warning was prompted by an FDA investigation that found 82 global cases of anaphylaxis associated with glatiramer acetate treatment that occurred from December 1996 through May 2024. However, the FDA notes this number may not reflect the total number of cases. Of these cases, 51 patients were hospitalized, 13 required intensive care, and 6 died. Most patients reported experiencing anaphylaxis after 1 hour of taking the medication.¹

Glatiramer acetate is an injectable immunomodulator used to decrease the number of relapses in patients with MS by lessening the immune system’s abnormal attack on nerves in the brain and spinal cord. It was originally approved by the FDA in 1996 for reduction of the frequency of relapses in patients with relapsing-remitting MS. According to the agency, approximately 240,000 glatiramer acetate prescriptions were dispensed in 2023, of which 32,000 patients received a dispensed prescription from US outpatient retail and mail order pharmacies.^1,2

Anaphylaxis is a rare, but serious life-threatening allergic reaction that causes the immune system to send the body into shock, resulting in decreased blood pressure and narrowing of the airways. It can be triggered by allergies to certain foods, insects, or materials, as well as medications. Patients should be treated immediately with an injection of epinephrine followed by a visit to the emergency room.^1,2

Symptoms of anaphylaxis include flushing, chest pain, palpitations, anxiety, shortness of breath, rash, or hives; however, its crucial to note that early symptoms can be similar to immediate post-injection reactions, a common reaction to glatiramer acetate. These reactions typically resolve within 15 to 30 minutes after administration compared with anaphylaxis, which may occur with the first dose, or after doses administered months or years after starting treatment.¹

The FDA also added new recommendations for patients and health care professionals about how to recognize the symptoms of anaphylaxis and seek medical attention promptly. Symptoms of anaphylaxis typically appear within 1 hour of injection and include wheezing or difficulty breathing, swelling of the face, lips, or throat, and hives. These symptoms can quickly progress to more serious symptoms, including severe rash or shock. Patients who experience anaphylaxis on glatiramer acetate should not resume treatment and speak with their health care provider about alternative options.¹

Health care professionals are urged to educate patients on the potential risks of glatiramer acetate and the importance of immediate medical attention if symptoms of anaphylaxis occur. Providers may also consider ensuring that patients have access to an epinephrine auto-injector as a precautionary measure.¹

The FDA continues to monitor the safety of glatiramer acetate and urges health care professionals and patients to report any adverse events to the FDA MedWatch program. These reports help the agency track potential risks and develop guidance to improve patient safety.¹

As MS treatments continue to evolve, ensuring patient safety through enhanced monitoring and education remains a priority. Patients are encouraged to maintain open communication with their health care teams and report any concerns promptly to address risks and explore alternative therapies when needed.

REFERENCES

1. FDA adds Boxed Warning about a rare but serious allergic reaction called anaphylaxis with the multiple sclerosis medicine glatiramer acetate (Copaxone, Glatopa). FDA. January 22, 2025. Accessed January 22, 2025. https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-about-rare-serious-allergic-reaction-called-anaphylaxis-multiple-sclerosis?utm_medium=email&utm_source=govdelivery

2. Anaphylaxis. Mayo Clinic. October 2, 2021. Accessed January 22, 2025. https://www.mayoclinic.org/diseases-conditions/anaphylaxis/symptoms-causes/syc-20351468