Anaphylaxis Boxed Warning Added to MS Medication Label

The Food and Drug Administration (FDA) has added a Boxed Warning to the prescribing information of glatiramer acetate, a medication for multiple sclerosis (MS) sold under the brand name Copaxone (glatiramer acetate injection; Teva, Tel Aviv-Yafo, Israel) and the generic name Glatopa (glatiramer acetate injection; Sandoz, Basel, Switzerland). The Boxed Warning is for the risk of anaphylaxis, a rare but potentially life-threatening allergic reaction which may occur any time during treatment, including immediately after the first dose or after months to years of use. The FDA is also updating the Warnings and Precautions section of glatiramer acetate’s prescribing information.

The new warnings were added based on the FDA’s identification of 82 cases of people experiencing serious anaphylaxis while using glatiramer acetate worldwide between December 1996 and May 2024. The FDA notes that these data only include cases submitted to the FDA and reported to the medical literature, meaning additional cases of anaphylaxis during glatiramer acetate treatment are likely.

Of these 82 cases of anaphylaxis:

• 51 patients were hospitalized
• 13 patients required intensive care
• 19 cases occurred ≥1 year after treatment initiation
• 6 patients died due to anaphylaxis
• Most patients experienced anaphylaxis within 1 hour of treatment

The FDA advises health care providers (HCPs) to be aware of the risk of anaphylaxis and monitor for symptoms of an anaphylactic event, which may overlap with common immediate post-injection reactions, but are typically more severe, worsen, or last longer, and require urgent medical attention.

The FDA’s Drug Safety Communication includes the following recommendations for HCPs:

• Educate patients on the signs and symptoms of anaphylaxis and advise patients to seek immediate medical attention by reporting to the emergency department or by contacting emergency services
• Do not restart treatment with glatiramer acetate for patients who have experienced anaphylaxis without identifying a clear alternative etiology.
• Encourage patients to read the Medication Guide that is included with their prescription.
• Report adverse events that occur after treatment with glatiramer acetate or other medications to the FDA MedWatch program.