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FDA warns of severe allergic reactions to certain multiple sclerosis drugs

FDA warns of severe allergic reactions to certain multiple sclerosis drugs

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Today, the FDA announced that rare but life-threatening allergic reactions associated with certain multiple sclerosis (MS) drugs, including glatiramer acetate (Copaxone, Teva) and its generic version, Glatopa, sold by Sandoz. issued a warning about the risk of anaphylaxis. .1

Today, the FDA issued a warning about the risk of anaphylaxis, a rare but life-threatening allergic reaction, associated with certain multiple sclerosis (MS) drugs. |Image credit: Tada Image – Stock.adobe.com

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Regulators added the most prominent safety warning, a boxed warning, to emphasize that anaphylaxis can occur at any point during treatment, from the first dose to years after starting the medication. I am doing it. Patients with symptoms such as wheezing, swelling, and difficulty breathing are advised to seek immediate medical attention.

“This serious allergic reaction, called anaphylaxis, can occur at any time during treatment, after the first dose, or after the drug is given months or years after starting,” the FDA says. stated in the announcement of concerns regarding sexuality. “Most patients who experience anaphylaxis from glatiramer acetate use develop symptoms within an hour after the injection. In some cases, patients have been hospitalized with anaphylaxis and even died.”

Copaxone was first approved by the FDA in 1996, and Glatopa was approved in 2015.3 Both are used to treat MS patients by reducing the immune system's abnormal attacks on nerves in the brain and spinal cord, which can help reduce the number of MS relapses. According to Symphony Health Metis, an estimated 240,000 glatiramer acetate prescriptions were filled in 2023, and an estimated 32,000 patients received filled prescriptions from outpatient retail pharmacies and mail order pharmacies in the United States.

The FDA's decision follows the identification of 82 global cases of anaphylaxis associated with glatiramer acetate from December 1996 to May 2024.1 In 19 of these cases, the response occurred more than 1 year after starting treatment. Symptoms usually appeared within an hour after administration and included wheezing, difficulty breathing, facial swelling, and hives. In severe cases, these reactions progress to life-threatening conditions such as shock. Six of the reported incidents resulted in death.

Glatiramer acetate is approved to treat relapsing forms of MS, a chronic disease that affects the central nervous system. The drug is administered by injection, and the FDA warns patients to seek immediate medical attention if they develop symptoms of an allergic reaction, especially if they persist or worsen over time. There is.

The FDA advises health care providers to inform patients of the potential risks and monitor them for signs of anaphylaxis, especially after the first dose. Teva and Sandoz have not yet responded to requests for comment on the latest safety measures.

This latest warning highlights the importance of vigilance when monitoring side effects associated with MS treatment drugs, as timely intervention is critical to managing severe allergic reactions.

“Early symptoms of anaphylaxis may overlap with those of a common reaction called an immediate injection reaction, which is temporary and begins shortly after an injection,” the FDA writes.2 “While reactions immediately after an injection are common, anaphylaxis is rare and the symptoms are usually more severe, worsen over time, and require treatment. Patients who develop a reaction after receiving a drug If your symptoms are more than mild, worsen over time, or don't go away in a short period of time, you should seek immediate medical attention.

References

1. The FDA warns of serious allergic reactions to some multiple sclerosis drugs. Reuters. January 22, 2025. https://www.reuters.com/business/healthcare-pharmaceuticals/fda-warns-serious-allergic-reactions-with-multiple-slerosis-drugs-2025-01-22/.

2. The FDA has added a boxed warning about a rare but serious allergic reaction called anaphylaxis with the multiple sclerosis drug glatiramer acetate (Copaxone, Glatopa). F.D.A. Drug safety communication. January 22, 20352. https://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-about-rare-serious-allergic-reaction-so-called anaphylaxis-multiple sclerosis.

3. FDA adds boxed warning to MS drug Copaxone. Formulary Watch. January 22, 2025. https://www.manatedhealthcareexecutive.com/view/fda-adds-boxed-warning-to-ms-drug-copaxone.

Sources

1/ https://Google.com/

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

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