This review is intended primarily for healthcare professionals. It provides a brief summary of key medicinal product safety information published in March 2023 by the Ministry of Health of Canada (Health Canada). The published information is not exhaustive.
New safety information on medicinal products
Medicinal products containing rocuronium – Assessment of the potential risk of mydriasis
This safety review assessed the risk of developing mydriasis associated with the use of medicinal products containing rocuronium. A review of the available information conducted by Health Canada found an association between the use of rocuronium and the risk of developing mydriasis in adult patients on mechanical ventilation with systemic infection, as well as in newborn infants who had undergone surgery. Mydriasis is expected to decrease after rocuronium is discontinued. Health Canada is working with registration certificate holders to update the instructions for medical use of medicinal products containing rocuronium to include information on the risk of mydriasis.
Key messages:
- Rocuronium is authorized for medical use in Canada for skeletal muscle relaxation during surgical operations as part of general anesthesia and for respiratory support (artificial lung ventilation) in patients who require intensive care.
- Health Canada has examined the potential risk of mydriasis with the use of rocuronium. The safety review was initiated by international literature reports of cases relating to this risk.
- A review of the available information conducted by Health Canada identified an association between the use of rocuronium and the risk of developing mydriasis in adult patients with systemic infection who are on mechanical ventilation, as well as in newborns who have undergone surgery. Mydriasis is expected to decrease after rocuronium is discontinued.
- Health Canada will work with registration certificate holders to update the instructions for medical use of medicinal products containing rocuronium in order to include information on the risk of mydriasis. Health Canada will also inform healthcare professionals about this update.
Overview:
- Health Canada reviewed the potential risk of developing mydriasis with the use of rocuronium (rocuronium). The safety review was initiated by international literature reports of cases related to this risk.
- Mydriasis is a condition in which the pupil does not respond to external light stimulation and remains large (dilated) for a long period. Mydriasis may be a sign that a serious disease is present that requires urgent care. It may also occur in response to the use of certain medicinal products.
The original text of this publication can be found at the link:
