FDA Issues Boxed Warning for Anaphylaxis Risk with Multiple Sclerosis Drugs Copaxone and Glatopa

FDA Action:
The FDA has added a boxed warning to the prescribing information for glatiramer acetate (Copaxone and Glatopa) due to the risk of anaphylaxis, a rare but serious allergic reaction23.

Anaphylaxis Cases:
82 global cases of anaphylaxis associated with glatiramer acetate have been identified, with symptoms typically appearing within one hour of injection. Six of these cases resulted in fatalities13.

Symptoms Overlap:
Initial symptoms of anaphylaxis can overlap with immediate post-injection reactions, which are common and temporary. However, anaphylaxis symptoms are more severe, worsen over time, and require treatment23.

Patient Guidance:
Patients are advised to seek immediate medical attention if they experience symptoms of anaphylaxis, such as wheezing, difficulty breathing, facial swelling, or hives23.

Drug Background:
Glatiramer acetate is used to treat relapsing forms of multiple sclerosis by lessening the immune system’s abnormal attack on nerves in the brain and spinal cord23.

Prescription Data:
In 2023, an estimated 240,000 glatiramer acetate prescriptions were dispensed, and approximately 32,000 patients received a dispensed prescription from U.S. outpatient retail and mail order pharmacies23.

Regulatory Context:
The FDA’s decision follows a similar notification from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in October 2024, which also outlined the risk of anaphylactic reactions1.

Sources:

1. https://www.pharmaceutical-technology.com/news/fda-adds-boxed-warning-to-multiple-sclerosis-drugs-after-anaphylaxis-cases/

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

3. https://www.ajmc.com/view/fda-warns-of-severe-allergic-reactions-with-certain-multiple-sclerosis-drugs