Anaphylactic reactions are a serious concern for patients with multiple sclerosis (MS) who are treated with glatiramer acetate, as warned by the European Medicines Agency (EMA). Healthcare professionals in the European Union will be issued advice regarding the risk of these reactions, which could occur even years after the initiation of treatment.
Glatiramer acetate is a disease-modifying therapy (DMT) for relapsing MS that is administered via injection. The drug has been used for over 20 years and has maintained a good safety profile. Common side effects include vasodilation, arthralgia, anxiety, hypertonia, palpitations, and lipoatrophy.
Anaphylactic Reactions Risk with Glatiramer Acetate Reviewed by EMA’s PRAC
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) reviewed evidence from an EU-wide analysis of all available data on anaphylactic reactions associated with glatiramer acetate during a meeting held on July 8-11. Based on this review, the committee concluded that the drug poses a risk for anaphylactic reactions, which may occur shortly after administration or even months or years later.
PRAC noted cases involving glatiramer acetate that resulted in fatal outcomes. The committee emphasized that initial symptoms of anaphylactic reactions could overlap with postinjection reactions, posing a risk for delay in identifying an anaphylactic reaction.
PRAC has approved a direct healthcare professional communication (DHPC) to inform healthcare providers about this risk. Patients and caregivers should be made aware of the signs and symptoms of an anaphylactic reaction and the need to seek emergency care if one occurs. In the event of such a reaction, treatment with glatiramer acetate must be discontinued, according to PRAC.
Anaphylactic Reactions to Glatiramer Acetate Documented in Medical Literature for Years
Anaphylactic reactions associated with the use of glatiramer acetate have been noted in medical literature for some years. A letter published in the journal European Neurology in 2011 by members of the department of neurology at Albert Ludwigs University Freiburg, Freiburg im Bresigau, Germany, detailed six cases of anaphylactoid or anaphylactic reactions in patients undergoing treatment with glatiramer acetate. In one of these cases, a grade 1 anaphylactic reaction occurred three months after the treatment was initiated.
The increasing recognition of these risks underscores the importance of ongoing vigilance and prompt response to potential anaphylactic reactions in patients treated with glatiramer acetate. Healthcare professionals must be equipped with the knowledge and resources to identify and manage these reactions to ensure patient safety.
As the use of glatiramer acetate continues in the management of MS, it is crucial that both patients and healthcare providers remain informed about the potential risks and the necessary steps to mitigate them. The EMA’s decision to issue this warning and the forthcoming DHPC aim to enhance awareness and preparedness in the clinical community, ultimately aiming to prevent adverse outcomes and ensure the well-being of patients with MS.
The PRAC’s findings and recommendations highlight the necessity for comprehensive patient education and the availability of emergency care options. This proactive approach by the EMA reflects a commitment to patient safety and the continuous improvement of therapeutic protocols in the treatment of multiple sclerosis.
Resource: Med Scape, July 12, 2024
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