The US Food and Drug Administration (FDA) is adding the risk of anaphylaxis to a new boxed warning of glatiramer acetate, a medicine for multiple sclerosis (MS).
The agency issued the warning about the rare but serious risk of allergic reaction to the medicine, known under the brand names Copaxone and Glatopa, via a drug safety communication on 22 January. The products already have warnings of immediate post-injection reaction, chest pain, localised fat loss, and immune response modification, as per the drugs’ labels.
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Teva Pharmaceutical’s Copaxone was approved by the FDA in 1996 to treat relapsing forms of MS, an autoimmune disorder that affects the central nervous system. Glatopa, a generic version of Teva’s product, was approved by the FDA this year and marketed by Sandoz. The drugs have demonstrated a 34% drop in the number of relapses compared to placebo.
The FDA adjusted the risk of the medicine after identifying 82 cases worldwide across the last 28 years. The agency said that although rare compared to how often the medicine is used, the serious allergic reactions meant emergency room visits or hospitalisations were required in all patients in the dataset. A majority of the 82 patients experienced anaphylaxis within one hour of taking the medicine and six died.
The FDA’s alert follows a similar notification from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in October 2024, which outlined the risk of anaphylactic reactions. The UK regulator said that allergy-related events could occur shortly after administration or take months or years after treatment initiation.
A multiple sclerosis patient from Castlebar in Ireland died shortly after administering herself with Copaxone in June 2024, according to local newspaper Mayo Live. A post-mortem concluded she died of anaphylactic shock and a ‘suspected adverse reaction report was submitted to Ireland’s Health Products Regulatory Authority (HPRA).
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By GlobalDataIdentifying anaphylaxis associated with glatiramer acetate can be challenging because its initial symptoms are similar to immediate post-injection reaction, a temporary and common side effect. The FDA recommended healthcare professionals to educate patients on the signs and symptoms of post-injection reactions and told patients to immediately stop taking glatiramer acetate in the event of breathing difficulties, face or throat swelling, or rash appearance.
Neither Teva nor Sandoz has publicly commented about the new boxed warning.
Teva faced difficulties with the European Commission with Copaxone in November 2024. The agency fined Teva €462.6m ($481m) after concluding that the company artificially extended the therapy’s patent protection and disseminated misleading information about rival products.
