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| Canada: Summary Safety Review: Rocuronium: Assessing the potential risk of mydriasis (English only) |
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Health Canada announces that it reviewed the potential risk of mydriasis with the use of rocuronium. The safety review was triggered by international case reports published in the literature concerning this risk.
Mydriasis is a condition in which the pupil is not responsive to external light stimulation and remains large (dilated) for a prolonged period. Rocuronium is a prescription drug that belongs to a group of drugs referred to as muscle relaxants. Rocuronium is authorized for sale in Canada to relax muscles during an operation as part of the general anesthesia and to facilitate mechanical ventilation in patients requiring intensive care.
Health Canada reviewed information provided by manufacturers, from foreign regulatory agencies, and from searches of the Canada Vigilance database and published literature. At the time of the review, Health Canada had not received any Canadian reports of mydriasis related to the use of rocuronium. Health Canada reviewed 9 international cases of mydriasis in patients administered rocuronium. Of the 9 cases assessed, 3 were found to be probably linked to the use of rocuronium, 2 were found to be possibly linked, 1 was unlikely to be linked and 3 could not be assessed.
Three cases (2 probable and 1 possible) involved adult patients with serious infection requiring mechanical ventilation. All 3 cases resolved following discontinuation of rocuronium. Two cases (1 probable and 1 possible) involved newborn infants undergoing surgery. One newborn infant experiencing prolonged general muscle relaxation received medication to reverse the mydriasis. The remaining case resolved following discontinuation of rocuronium.
Health Canada's review of the available information found a link between the use of rocuronium and the risk of mydriasis in mechanically ventilated adult patients with systemic infection, and in newborn infants undergoing surgery. Mydriasis is expected to reverse when rocuronium is discontinued. Health Canada will work with the manufacturers to update the Canadian product monograph for rocuronium-containing products to include the risk of mydriasis.
Please refer to the following website in Health Canada for details:
http://hpr-rps.hres.ca/../summary-safety-review-detail.php?lang=en&linkID=SSR00292
In Hong Kong, there are 7 registered pharmaceutical products containing rocuronium. All products are prescription-only medicines. So far, the Department of Health has not received any case of adverse drug reaction related to rocuronium. 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, Feb 10, 2023
Issued at HKT 15:00
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