FDA Adds Boxed Warning to Teva’s Copaxone and Generic Glatopa Due to Anaphylaxis Risk

FDA Action:
The FDA has added a Boxed Warning to the prescribing information of glatiramer acetate (Copaxone and Glatopa) due to the risk of anaphylaxis, a rare but potentially life-threatening allergic reaction23.

Anaphylaxis Risk:
Anaphylaxis can occur at any time during treatment with glatiramer acetate, including immediately after the first dose or after doses administered months or years after starting the medicine34.

Symptoms and Severity:
Symptoms of anaphylaxis 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, which is a life-threatening condition34.

Case Data:
The FDA reviewed 82 serious cases of anaphylaxis worldwide associated with glatiramer acetate use between December 1996 and May 2024. Of these, 51 patients were hospitalized, 13 required intensive care, and six died35.

Immediate Action Required:
Patients experiencing symptoms of anaphylaxis should stop taking glatiramer acetate and seek immediate medical attention by going to an emergency room or calling 91134.

Differentiation from Immediate Post-Injection Reaction:
Anaphylaxis symptoms can overlap with those of immediate post-injection reactions, which are common and temporary. However, anaphylaxis symptoms are typically more severe, worsen over time, and require urgent medical attention34.

Treatment and Precautions:
The FDA advises healthcare providers to monitor for symptoms of anaphylaxis and to be aware that anaphylaxis can occur at any time during treatment. Patients should not restart glatiramer acetate if they have experienced anaphylaxis unless another clear cause is identified34.

Sources:

2. https://practicalneurology.com/news/anaphylaxis-boxed-warning-added-to-ms-medication-label

3. https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-about-rare-serious-allergic-reaction-called-anaphylaxis-multiple-sclerosis

4. https://www.fda.gov/safety/medical-product-safety-information/copaxone-glatopa-glatiramer-acetate-drug-safety-communication-fda-adds-boxed-warning-about-rare

5. https://www.managedhealthcareexecutive.com/view/fda-adds-boxed-warning-to-ms-drug-copaxone