FDA adds Boxed Warning about a rare but serious allergic reaction called anaphylaxis with the multiple sclerosis medicine glatiramer acetate (Copaxone, Glatopa)
Patients should stop taking glatiramer acetate and seek immediate medical attention by going to an emergency room or calling 911 if you experience symptoms of an anaphylactic reaction. Symptoms generally appear within one hour of injection and include wheezing or difficulty breathing, swelling of the face, lips, or throat, and hives. These symptoms can quickly progress to more serious symptoms, including severe rash or shock, which is a life-threatening condition. Anaphylaxis can occur at any point during glatiramer acetate treatment, including years after starting treatment. You should not restart glatiramer acetate if you have experienced anaphylaxis unless another clear cause for anaphylaxis is identified. Talk to your health care professional if you have any questions or concerns about glatiramer acetate.
Patients should be aware that the early symptoms of anaphylaxis can be similar to a temporary reaction that sometimes happens right after or within minutes after an injection of the medicine into the skin.This immediate post-injection reaction goes away on its own, usually within 15-30 minutes, with no specific treatment. This reaction can occur with the first dose, or after doses administered months or even years after starting the medicine. This immediate post-injection reaction may involve symptoms such as flushing, chest pain, palpitations, anxiety, shortness of breath, rash, or hives. Call the health care professional who prescribed the medicine if you have any of these immediate post-injection reaction symptoms. Do not continue taking more injections until your prescriber tells you to do so. Seek immediate medical attention by going to an emergency room or calling 911 if any of these symptoms worsen or do not go away.
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