Patients taking multiple sclerosis (MS) medication have been alerted to rare cases of anaphylaxis, with the US Food & Drug Administration having now added a boxed warning about the drug glatiramer acetate (Copaxone, Glatopa).
The alert indicates that anaphylaxis can occur at any time, from as early as after the first dose or after doses administered years after starting treatment.
It also adds new recommendations for patients and healthcare professionals about the critical importance of quickly identifying and treating symptoms of anaphylaxis.
Medpage Today reports that glatiramer acetate is an injectable drug that was approved in 1996 to treat relapsing forms of MS. It’s available as both branded and generic products.
The boxed warning was based on 82 serious cases of anaphylaxis associated with glatiramer acetate between December 1996 and May 2024, said the FDA. Of these, 19 cases reported anaphylaxis more than one year after starting treatment. The median time to onset of anaphylaxis from starting glatiramer acetate was five months (range one day-72 months).
Of the 82 patients, 51 were admitted to hospital, including 13 who required care in the ICU. Six of them died.
Most of the 82 patients experienced anaphylaxis within an hour of taking the medication. One case entailed shock and sudden death after the first dose.
Patients were treated with epinephrine or adrenaline in 32 cases, corticosteroids in 21 cases, mechanical ventilation in five cases, and cardiopulmonary resuscitation in one case.
Symptoms of an anaphylactic reaction generally appear within one hour of injection and include wheezing or difficulty breathing; swelling of the face, lips, or throat; and hives, the FDA noted. They can quickly progress to more serious symptoms, including severe rash or shock.
Early symptoms of anaphylaxis can be similar to post-injection reactions, which are generally transient, self-limited, and resolve within 30 minutes, the agency pointed out. Those associated with anaphylaxis are typically more severe, worsen, or last longer, and require urgent medical attention.
The 82 cases included only reports submitted through the FDA Adverse Event Reporting System (FAERS) database and those found in the medical literature, “so there may be additional cases about which we are unaware”, the agency said.
In July last year, the European Medicines Agency’s safety committee also warned about anaphylactic reactions that it said might occur months up to years after starting treatment.
Medpage Today article – FDA Warns About Anaphylaxis Risk With MS Drug (Open access)
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