Summary Safety Review - Rocuronium - Assessing the Potential Risk of Mydriasis

Review decision

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.


Issued: 2023-02-09

Product

Rocuronium-containing products

Potential Safety Issue

Fixed dilated pupils (mydriasis)

Key Messages

  • Rocuronium is authorized for sale in Canada to relax muscles during an operation as part of the general anesthesia and to facilitate assisted breathing (mechanical ventilation) in patients requiring intensive care.

  • Health Canada 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.

  • 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 product safety information in the Canadian product monograph (CPM) for rocuronium-containing products to include the risk of mydriasis. Health Canada will also inform healthcare professionals about this update through a Health Product InfoWatch communication.

Overview

Health Canada 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 risk1,2.

Mydriasis is a condition in which the pupil is not responsive to external light stimulation and remains large (dilated) for a prolonged period. Mydriasis may be a sign that the patient is experiencing a serious medical condition that requires urgent attention. It may also occur in response to the use of certain drugs.

Use in Canada

  • 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.

  • Rocuronium has been marketed in Canada since 1995. It is currently available as a 10 mg / mL solution for injection. Various generic rocuronium products are available in Canada.

  • Rocuronium is administered by a healthcare professional and is usually used in a hospital setting.

Safety Review Findings

  • Health Canada reviewed information provided by manufacturers, from foreign regulatory agencies, and from searches of the Canada Vigilance databasea 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 also reviewed articles published in the scientific literature, which explain how rocuronium may lead to mydriasis.

Conclusions and actions

  • 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 CPM for rocuronium-containing products to include the risk of mydriasis.

  • Health Canada will also inform healthcare professionals about this update through a Health product InfoWatch communication.

  • Health Canada encourages consumers and healthcare professionals to report any side effects related to the use of rocuronium and other health products to the Canada Vigilance Program.

  • Health Canada will continue to monitor safety information involving rocuronium, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action should new health risks be identified.

Additional information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international information, and what is known about the use of rocuronium both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

References

  1. Rodrigues, E., da Costa G., Braga D., Pinto J., Lessa M. (2021). Rocuronium-Induced Dilated Nonreactive Pupils in a Patient With Coronavirus Disease 2019: A Case Report. A&A Practice 15(7):p e01491.

  2. Zakynthinos G., Tsolaki V., Bardaka F., Makris D. (2021). Fixed dilated pupils in Covid-19 ARDS patients under rocuronium, reversed after discontinuation. Journal of Critical Care, Volume 65, 259-260.

Footnotes

  1. Canadian reports can be accessed through the Canada Vigilance Online Database.

Report a problem or mistake on this page
Please select all that apply:
Date modified: