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# New Copaxone Boxed Warning
- URL: https://www.fdaweb.com/new-copaxone-boxed-warning/
- Published: 2025-01-22T12:00:00.000Z
- Updated: 2026-09-14T14:51:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158523

FDA says it is adding a Boxed Warning for anaphylaxis, a rare but serious allergic reaction, to the labeling for Teva’s multiple sclerosis drug Copaxone (glatiramer acetate) and Glatopa, Sandoz’ generic version. An agency [statement](https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-about-rare-serious-allergic-reaction-called-anaphylaxis-multiple-sclerosis?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the reaction can occur at any time while on treatment. “For most patients who experienced anaphylaxis with glatiramer acetate use,” FDA says, “the symptoms appeared within one hour of injection. In some cases, anaphylaxis resulted in hospitalization and death.”

The statement says the information in the Boxed Warning is also being added to the Warnings and Precautions section of the labeling. Patients are being advised to stop taking the drug and seek immediate medical attention if symptoms of anaphylaxis occur.

FDA says it reviewed 82 serious cases of anaphylaxis worldwide associated with glatiramer acetate in its FDA Adverse Event Reporting System database and medical literature since the product was approved in 12/1996 through 5/2024\. Of the 82 patients, it says, 51 were hospitalized for anaphylaxis, including 13 who required care in an intensive care unit and six who died. The notice says it is likely there have been additional cases that were not reported to FDA or cited in the literature.