News Briefs: FDA Warns About Anaphylaxis Risk With Glatiramer Acetate
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Feb 13, 2025
The FDA warned that glatiramer acetate can cause anaphylaxis at any time while undergoing treatment with the multiple sclerosis drug, the agency said in a Drug Safety Communication on Jan. 22. While the reaction is rare, it has resulted in hospitalization and death, said the agency, which identified 82 cases worldwide that occurred from December 1996 through May 2024. Of those, 19 occurred more than a year after starting treatment, and six died. Most experienced anaphylaxis within one hour of taking the drug, which is available as Teva Neuroscience, Inc.’s Copaxone and Sandoz Inc.’s Glatopa, as well as multiple generics. The FDA is adding the risk to a new boxed warning on the drugs’ labels, as well as updating the Warning and Precautions section. Patients should seek immediate medical attention by going to an emergency room or calling 911, the agency recommended, and providers should educate patients on the signs of anaphylaxis. The medication should not be restarted unless a clear alternative reason for the response is identified. It recommends that patients and health care providers report any side effects of the drug to the FDA’s MedWatch.
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