SOn the recommendation of the European Pharmacovigilance Committee (PRAC), the French and European health authorities warn against the risk of anaphylactic reactions associated with glatiramer acetate. [1]a drug indicated in the treatment of certain forms of multiple sclerosis (MS).
In France, this alert concerns the following specialties:
The summaries of product characteristics (SPCs) and the leaflets for these specialties will be updated to mention this risk and the course of action to be taken.
Treatment with glatiramer acetate should be discontinued if an anaphylactic reaction occurs.
All patients are concerned
To date, no evidence has been identified that would allow the identification of factors or populations at risk of developing this adverse effect.
Anaphylactic reactions associated with glatiramer acetate are uncommon (≥ 1/1,000 and
They can occur in all patients, including after several months or years of regularly administered and well-tolerated treatment.
Data indicate a rapid onset of anaphylactic reactions, immediately after administration.
Inform patients and caregivers about the risk and what to do
Patients treated with glatiramer acetate and their caregivers should be informed of the signs and symptoms suggestive of serious allergy.
“The initial symptoms of anaphylactic reactions may be confused for some with those of postinjection reactions, potentially delaying the identification of an anaphylactic reaction.”warn the laboratories in a letter addressed to health professionals [2]As a reminder, the signs of immediate post-injection reactions described in the SPC are vasodilation, chest pain, dyspnea, palpitations or tachycardia.
If signs suggestive of an anaphylactic reaction to glatiramer occur, immediate emergency medical attention is recommended.
