Other safety alerts
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| Canada: Summary Safety Review: Ilaris (canakinumab): Assessing the potential risk of drug reaction with eosinophilia and systemic symptoms |
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Health Canada announces that it reviewed the potential risk of drug reaction with eosinophilia and systemic symptoms (DRESS) with the use of Ilaris (canakinumab). The safety review was triggered by a labelling update by the European Medicines Agency and Health Canada’s subsequent review of routine safety reports from the manufacturer of Ilaris.
Ilaris is a prescription drug belonging to a class of drugs called interleukin-1 (IL-1) inhibitors. It is authorized for sale in Canada for the treatment of various inflammatory conditions, including Still’s disease, a rare type of inflammatory arthritis occurring in children as systemic juvenile idiopathic arthritis (sJIA) and in adults as adult-onset Still’s disease.
Health Canada reviewed the available information provided by the manufacturer, and from searches of the Canada Vigilance database and the scientific literature. Health Canada reviewed 27 cases (1 Canadian and 26 international) of DRESS in patients taking Ilaris. Of those 27 cases, 4 were found to be possibly linked to the use of Ilaris, 5 (1 Canadian) were unlikely to be linked and 18 could not be assessed due to missing information. The 4 possible cases were reported in pediatric patients, 3 of whom were being treated for sJIA. One death was reported among the 4 possible cases. It is unclear whether DRESS was a contributing factor to the death.
Health Canada’s review of the available information concluded that there is a possible link between the use of Ilaris and the risk of DRESS. Health Canada is working with the manufacturer to update the Canadian product monograph for Ilaris with a warning about reported cases of DRESS, predominantly in patients with sJIA. Health Canada will also inform healthcare professionals about this update through a Health Product InfoWatch communication.
Please refer to the following website in Health Canada for details:
http://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1732291653402
In Hong Kong, there is one registered pharmaceutical product containing canakinumab, namely Ilaris Solution For Injection 150mg/ml (HK-65635). The product is registered by Novartis Pharmaceuticals (HK) Limited. It is a prescription-only medicine. So far, the Department of Health (DH) has not received any case of adverse drug reaction with regard to canakinumab. In light of the above Health Canada’s announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Friday, Dec 20, 2024
Issued at HKT 17:30
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