Other safety alerts
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| European Union: Glatiramer acetate: anaphylactic reactions may occur months up to years after treatment initiation |
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European Medicines Agency (EMA) announces that following an EU-wide review of all available data concerning anaphylactic reactions with glatiramer acetate, a medicine authorised for the treatment of relapsing forms of multiple sclerosis, the Pharmacovigilance Risk Assessment Committee (PRAC) concluded that the medicine is associated with anaphylactic reactions, which may occur shortly following administration of glatiramer acetate even after months up to years after initiation of treatment. Cases with a fatal outcome have been reported. Initial symptoms of anaphylactic reactions may overlap with symptoms of post-injection reaction and could potentially lead to a delay in the identification of an anaphylactic reaction.
The PRAC has agreed a direct healthcare professional communication (DHPC) to inform healthcare professionals about this risk and to recommend that patients and/or caregivers be advised of the signs and symptoms and to seek emergency care in the event of an anaphylactic reaction. If such a reaction occurs, treatment with glatiramer acetate must be discontinued.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-july-2024
In Hong Kong, there is no pharmaceutical product containing glatiramer acetate registered.
Ends/ Saturday, Jul 13, 2024
Issued at HKT 13:00
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