Other safety alerts
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| Canada: Summary Safety Review: Isotretinoin: Assessing the potential risk of sacroiliitis |
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Health Canada announces that it reviewed the potential risk of sacroiliitis associated with the use of isotretinoin. The safety review was triggered by a labelling update by the European Medicines Agency.
Isotretinoin is a prescription drug authorized for sale in Canada for the treatment of severe forms of acne in patients 12 years of age and older that should be used when the acne fails to respond to other treatments.
Health Canada reviewed the available information provided by manufacturers, as well as from searches of the Canada Vigilance database, international databases and the scientific literature. Health Canada reviewed 24 international cases of sacroiliitis in patients taking isotretinoin. Of those 24 cases, 23 were found to be possibly linked to the use of isotretinoin and 1 was unlikely to be linked. The average age was 20 years in cases where the age was provided. No deaths were reported among the 24 cases reviewed.
Health Canada also reviewed 18 articles published in the scientific literature. While the studies supported a link between the risk of sacroiliitis and the use of isotretinoin, they did not identify a clear biological mechanism to explain how isotretinoin use could lead to sacroiliitis. In both the cases reviewed and the scientific literature, sacroiliitis improved after discontinuation of isotretinoin and appropriate treatment.
Health Canada’s review of the available information found a possible link between isotretinoin and the risk of sacroiliitis. Health Canada is working with the manufacturers to update the Canadian product monograph for isotretinoin-containing products to include the risk of sacroiliitis. 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/SSR1739474283557
In Hong Kong, there are 13 registered pharmaceutical products containing isotretinoin. All products are prescription-only medicines. So far, with regard to isotretinoin, the Department of Health (DH) has received 2 cases of adverse drug reaction, but these cases were not related to sacroiliitis. 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, Mar 28, 2025
Issued at HKT 17:45
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