The U.S. Food and Drug Administration (FDA) has issued a 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).
According to the US Federal agency, 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,” it stated.
The USFDA has added boxed warning about the reaction.
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. We are adding a new Boxed Warning about this risk to the glatiramer acetate prescribing information and patient Medication Guide. We are adding the risk of anaphylaxis to a new Boxed Warning, FDA’s most prominent 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 stated.
The agency also added 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 or calling 911 if symptoms of anaphylaxis occur,” it added.
What is Glatiramer acetate?
The US agency maintains that Glatiramer acetate is an 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. 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. The first glatiramer acetate product, Copaxone, was approved in 1996,” it added.
What should the patients do?
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, FDA warned.
According to the federal agency, 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,” it stated.
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,” it added.
The FDA has identified 82 worldwide cases of anaphylaxis associated with glatiramer acetate occurring from December 1996 through May 2024, including 19 cases that reported anaphylaxis more than one year after starting the medicine.
“The 82 worldwide cases include only reports submitted to FDA and found in the medical literature so there are likely additional cases about which we are unaware. While anaphylaxis in these cases appears to be rare compared to how often the medicine is used (see Facts about Glatiramer Acetate), these 82 patients reported serious outcomes that required emergency room visits or hospitalizations for medical treatment, and six died. A majority of the 82 patients experienced anaphylaxis within one hour of taking the medicine,” it added.
To help FDA track safety issues with medicines, we urge patients and health care professionals to report side effects involving glatiramer acetate or other medicines to the FDA MedWatch program using the information in the “Contact FDA” box at the bottom of this page, it added.
