Other safety alerts
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| The United States: FDA adds Boxed Warning about a rare but serious allergic reaction called anaphylaxis with the multiple sclerosis medicine glatiramer acetate (Copaxone, Glatopa) |
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The United States Food and Drug Administration (FDA) is warning about the risk of a rare but serious allergic reaction with the medicine glatiramer acetate (Copaxone, Glatopa), which is used to treat patients with multiple sclerosis (MS). This serious allergic reaction, called anaphylaxis, can occur at any time while on treatment, after the first dose or after doses administered months or years after starting the medicine. For most patients who experienced anaphylaxis with glatiramer acetate use, the symptoms appeared within one hour of injection. In some cases, anaphylaxis resulted in hospitalization and death.
The initial symptoms of anaphylaxis can overlap with those of a common reaction called immediate post-injection reaction that is temporary and can start soon after a shot is given. While immediate post-injection reaction is common, anaphylaxis is rare and its symptoms are typically more severe, worsen over time, and require treatment. Patients experiencing a reaction after the medicine is administered should seek immediate medical attention if the symptoms are more than mild, get worse over time, or do not go away within a brief time.
FDA is adding the risk of anaphylaxis to a new Boxed Warning and to the Warnings and Precautions section of the glatiramer acetate prescribing information. These warnings include information that anaphylaxis can occur at any time, from as early as after the first dose or after doses administered years after starting the medicine. FDA is also adding new recommendations for patients and health care professionals about the critical importance of quickly recognizing and treating symptoms of anaphylaxis. The updated prescribing information also instructs patients to stop taking the medicine and seek immediate medical attention by going to an emergency room if symptoms of anaphylaxis occur.
Glatiramer acetate is an FDA-approved medicine to treat patients with relapsing forms of MS. It works by lessening the immune system’s abnormal attack on nerves in the brain and spinal cord. This medicine helps decrease the number of MS relapses. In USA, glatiramer acetate is available as an injectable medicine administered daily or three times per week, depending on dosage, under the brand name Copaxone, branded generic name Glatopa, and as other generic glatiramer acetate products.
Health care professionals should be aware that fatal anaphylaxis has occurred with glatiramer acetate, including years after treatment has been initiated and that the symptoms of these rare anaphylactic events may overlap with those of common immediate post-injection reactions. Symptoms such as flushing, chest pain, palpitations, anxiety, shortness of breath, rash, or hives typically occur within minutes after an injection and are generally transient, self-limited, and resolve without specific treatment within 30 minutes. Those associated with anaphylaxis are typically more severe, worsen, or last longer, requiring urgent medical attention.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/fda-adds-boxed-warning-about-rare-serious-allergic-reaction-called-anaphylaxis-multiple-sclerosis
In Hong Kong, there is no registered pharmaceutical product containing glatiramer acetate. Related news was previously issued by European Medicines Agency, and was posted on the Drug Office website on 13 Jul 2024.
Ends/ Thursday, January 23, 2025
Issued at HKT 12:45
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