Skip to main content

Drug Safety Communication: Copaxone, Glatopa (glatiramer acetate) - FDA Adds Boxed Warning About a Rare but Serious Allergic Reaction Called Anaphylaxis

Audience: Patient, Caregiver, Health Care Professional, Pharmacy, Neurology

ISSUE: The FDA is warning about the risk of a rare but serious allergic reaction with the medicine glatiramer acetate (Copaxone, Glatopa), which is used to treat patients with multiple sclerosis (MS). This serious allergic reaction, called anaphylaxis, can occur at any time while on treatment, after the first dose or after doses administered months or years after starting the medicine. For most patients who experienced anaphylaxis with glatiramer acetate use, the symptoms appeared within one hour of injection. In some cases, anaphylaxis resulted in hospitalization and death.

The initial symptoms of anaphylaxis can overlap with those of a common reaction called immediate post-injection reaction that is temporary and can start soon after a shot is given. While immediate post-injection reaction is common, anaphylaxis is rare and its symptoms are typically more severe, worsen over time, and require treatment. Patients experiencing a reaction after the medicine is administered should seek immediate medical attention if the symptoms are more than mild, get worse over time, or do not go away within a brief time. FDA is adding a new Boxed Warning about this risk to the glatiramer acetate prescribing information and patient Medication Guide.

For more information about this alert, click on the red button "Read Alert" below.

BACKGROUND: Glatiramer acetate is an FDA-approved medicine to treat patients with relapsing forms of MS. Glatiramer acetate is available as an injectable medicine administered daily or three times per week, depending on dosage, under the brand name Copaxone, branded generic name Glatopa, and as other generic glatiramer acetate products.

RECOMMENDATIONS:

Patients and Caregivers

Health Care Professionals

Health care professionals, patients and caregivers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Content current as of: January 22, 2025

Source: FDA

More news resources

Subscribe to our newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.