USA – The U.S. Food and Drug Administration (FDA) has issued a new boxed warning for glatiramer acetate, a treatment for multiple sclerosis (MS), highlighting the risk of anaphylaxis—a rare but severe allergic reaction.
The warning, announced on January 22 via a drug safety communication, applies to the branded medications Copaxone (by Teva Pharmaceuticals) and its generic version, Glatopa (marketed by Sandoz).
These drugs already carry warnings about post-injection reactions, chest pain, localized fat loss, and immune response modification.
Teva’s Copaxone was approved by the FDA in 1996 to manage relapsing forms of MS, a chronic autoimmune condition affecting the central nervous system.
Glatopa, a generic equivalent, received FDA approval in 2024. Clinical studies have shown the treatment reduces relapse rates in MS patients by 34% compared to placebo.
The FDA’s decision to enhance the warning stems from an analysis of 82 anaphylaxis cases reported globally over the last 28 years.
While rare in proportion to the widespread use of glatiramer acetate, the cases were significant enough to prompt concern.
According to the FDA, all affected patients required emergency care or hospitalization, with most experiencing anaphylaxis within an hour of administration. Tragically, six patients died due to the reaction.
The alert mirrors a similar warning issued in October 2024 by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), which also highlighted the risk of anaphylactic reactions.
The MHRA noted that these events could occur shortly after injection or even months or years into treatment.
In a reported case from Castlebar, Ireland, a woman died from anaphylactic shock in June 2024 after administering Copaxone.
A post-mortem examination confirmed the reaction as the cause of death, and a report was submitted to Ireland’s Health Products Regulatory Authority (HPRA).
One of the challenges in identifying anaphylaxis linked to glatiramer acetate lies in its similarity to immediate post-injection reactions, which are common and generally mild.
The FDA urged healthcare providers to educate patients about the symptoms of severe allergic reactions, including breathing difficulties, swelling of the face or throat, and the appearance of rashes.
Patients experiencing these symptoms should discontinue the medication immediately and seek medical attention.
Teva Pharmaceuticals and Sandoz have yet to comment publicly on the updated warning.
This latest development follows additional challenges for Teva, including a €462.6 million (US $481 million) fine imposed by the European Commission in November 2024.
The commission concluded that Teva artificially extended patent protections for Copaxone and disseminated misleading information about competing products.