The FDA is alerting the public to the risk of anaphylaxis, a rare but serious allergic reaction, associated with glatiramer acetate (Copaxone, Glatopa), a drug used to treat multiple sclerosis (MS). Anaphylaxis can occur at any time during treatment, even after doses administered months or years after starting the medicine, and has sometimes resulted in hospitalization and death. Symptoms typically appear within one hour of injection.
To communicate this risk, the FDA is adding a Boxed Warning to the prescribing information and patient Medication Guide. Patients should stop taking glatiramer acetate and seek immediate medical attention if they experience symptoms of anaphylaxis such as wheezing, difficulty breathing, swelling of the face, lips, or throat, or hives. While early symptoms of anaphylaxis can be similar to a temporary post-injection reaction, they are typically more severe and worsen over time. If symptoms are more than mild, worsen, or do not go away quickly, patients should seek immediate medical attention
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