MS Drug Associated with Rare Cases of Anaphylaxis, FDA Warns
The U.S. Food and Drug Administration (FDA) is warning of rare, life-threatening allergic reactions associated with the injectable multiple sclerosis drug glatiramer acetate (Copaxone, Glatopa). Since its approval in December 1996, 82 patients worldwide have required emergency care or hospitalization for anaphylaxis after injection with the medication, including 6 patients who died.
The FDA will add a new boxed warning about the risk of anaphylaxis to glatiramer acetate prescribing information and the patient medication guide.
“These warnings include information that anaphylaxis can occur at any time, from as early as after the first dose or after doses administered years after starting the medicine,” the FDA explained in a statement on its website. “We are also adding new recommendations for patients and health care professionals about the critical importance of quickly recognizing and treating symptoms of anaphylaxis.”
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Most reported anaphylaxis reactions occurred within 1 hour of injection, according to the FDA. Initial symptoms can overlap with the more common immediate post-injection reaction, which can start after a patient receives an injection and is temporary, resolving within 15 to 30 minutes. Symptoms of anaphylaxis tend to be more severe, worsen over time, and require emergency treatment. They include wheezing or difficulty breathing; swelling of the face, lips, or throat; hives; and severe rash.
“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,” the FDA advised.
An FDA investigation identified 82 cases of anaphylaxis associated with glatiramer acetate in the FDA Adverse Event Reporting System and medical literature through May 2024. Among the patients, 51 were hospitalized, 13 received care in the intensive care unit, and 6 died. The time from starting glatiramer acetate to anaphylaxis onset ranged from 1 day to 72 months.
The FDA said more patients have likely experienced anaphylaxis associated with use of the drug, since those identified consisted entirely of reported cases. To provide context, however, it added that since glatiramer acetate’s launch, there have been more than 3 million patient-years of exposure to the medication.
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