HQ Team
January 22, 2025: The US drug regulator has issued its most prominent warning on the use of certain drugs to treat multiple sclerosis, saying it may cause hospitalisation and death due to a ârare but seriousâ allergic reaction.
âThis 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,â according to a statement from the Food and Drug Administration (FDA).
The medicine glatiramer acetate is used to treat patients with multiple sclerosis, and companies that manufacture under their brands include Israelâs Teva Pharmaceutical Industries Ltd., (Copaxone) and Switzerlandâs Sandoz AG (Glatopa).
The initial symptoms of anaphylaxis can overlap with those of a common reaction called immediate post-injection reaction which is temporary and can start soon after a shot is given.Â
Boxed Warning
While the immediate post-injection reaction is common, anaphylaxis is rare, and its symptoms are typically more severe, worsen over time, and require treatment.Â
The FDA added a new Boxed Warning about this risk to the glatiramer acetate prescribing information and patient Medication Guide.
The US regulator reviewed 82 serious cases of anaphylaxis worldwide associated with glatiramer acetate in the FAERS database and medical literature since the product was approved in December 1996 through May 2024.
Of the 82 patients, 51 were hospitalised for anaphylaxis, including 13 who required care in the intensive care unit, and six died. âOne patient case described shock and sudden death after the first dose, and the duration of treatment was not reported for three patients.â
Symptoms within an hour
The median time to onset of anaphylaxis from starting glatiramer acetate was five months, ranging from one day to 72 months in the FDA-reviewed patient cases.
In a majority of patients who experienced anaphylaxis with glatiramer acetate use, the symptoms appeared within one hour of injection.
Symptoms 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, according to the FDA.
Immune system
Glatiramer acetate is an FDA-approved medicine to treat patients with relapsing forms of multiple sclerosis.
It works by lessening the immune systemâs abnormal attack on nerves in the brain and spinal cord.Â
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.
