Anaphylaxis is a serious allergic reaction that might occur due to glatiramer acetate, a drug used to treat the relapsing forms of multiple sclerosis (MS). The US Food and Drug Administration (FDA) recently issued a warning about this rare risk. This drug, sold under the brand name Copaxone and its generic versions, such as Glatopa, reduces the abnormal attack of the immune system on the nerves in the brain and spinal cord, thereby reducing the frequency of MS relapses.
The FDA has now added a Boxed Warning for glatiramer acetate. This warning calls attention to the fact that anaphylaxis may happen at any point while receiving therapy, from just after the initial dosage to several years later. A similar update has also been added to the Warnings and Precautions section of the prescribing guidelines.
Anaphylaxis resulting from glatiramer acetate use is extremely rare but has serious consequences, such as hospitalization and death. The FDA identified 82 cases of anaphylaxis worldwide between December 1996 and May 2024; six were fatal. Significantly, 19 of these cases occurred more than one year after patients began treatment.
Symptoms of anaphylaxis, which often happen within an hour after the injection, include rash, shortness of breath, hives, palpitations, chest pain, anxiety, and flushing. These symptoms may overlap with a more common immediate post-injection reaction experienced by some patients. Although post-injection reactions are usually mild, self-limiting, and resolve within 30 minutes, anaphylaxis symptoms are more severe, worsening over time and requiring urgent medical intervention.
The FDA highlights that patients should be educated on the symptoms of anaphylaxis and instructs the patients about emergency situations. It is recommended that patients seek medical assistance right away if their symptoms intensify or do not improve. Additionally, the FDA advises that a patient who has experienced anaphylaxis during treatment with glatiramer acetate should not resume the medication unless another cause for the reaction is identified.
Healthcare professionals must remain vigilant for anaphylaxis, even in patients who have been on the medication for years. Early recognition and prompt treatment can prevent serious outcomes. Glatiramer acetate was first approved by the FDA in 1996 and is given in the form of injection daily or three times a week, depending on the dose. In 2023, approximately 240,000 prescriptions for glatiramer acetate were dispensed, reaching an estimated 32,000 patients through U.S. outpatient retail and mail-order pharmacies.
Although anaphylaxis remains rare in comparison to the wide use of the medication, the review by the FDA points out the necessity of increased awareness among patients as well as among healthcare providers. According to the agency, any drug has side effects, and individuals may respond differently due to medical conditions, genetic factors, and other treatments.
The updated warnings from the FDA are set to alert both patients and healthcare providers about this rare but serious risk of anaphylaxis from glatiramer acetate. They are also asked to continually discuss their concerns with healthcare professionals and observe themselves for symptoms that require urgent care. By adopting this proactive approach, the FDA underlines its commitment to patient safety without compromising the availability of a treatment as important as this for MS.
References: Food and Drug Administration. FDA adds Boxed Warning about a rare but serious allergic reaction called anaphylaxis with the multiple sclerosis medicine glatiramer acetate (Copaxone, Glatopa). Published January 22, 2025. Accessed January 24, 2025. https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-about-rare-serious-allergic-reaction-called-anaphylaxis-multiple-sclerosis
