Importation of US-Labelled Vecuronium Bromide for Injection due to Shortage of Neuromuscular Blocker Products
- Starting date:
- April 29, 2020
- Type of communication:
- Dear Healthcare Professional Letter
- Subcategory:
- Drugs
- Source of recall:
- Health Canada
- Issue:
- Important Safety Information, Labelling and Packaging
- Audience:
- Healthcare Professionals, Hospitals
- Identification number:
- RA-72901
Last updated: 2020-04-29
Audiences
Healthcare professionals including pharmacists, anesthesiologists, critical care physicians, emergency physicians and those involved with administering anesthesia or intubating patients.
Key messages
- There is an unprecedented demand and shortage of Neuromuscular Blocker (NMB) products in Canada as a result of the COVID-19 pandemic.
- Vecuronium Bromide Injection is a non-depolarizing NMB agent of intermediate duration that is not currently authorized for use in Canada. However, given the medical necessity of NMBs Health Canada has added US-labelled Vecuronium Bromide for Injection 10mg in a fliptop vial (1 mg/mL when reconstituted to 10 mL) to the List of Drugs for Exceptional Importation and Sale.
- Healthcare professionals should be aware of the potential risk of errors resulting from inadvertent selection and administration of NMBs, resulting in serious harm to patients.
- Proper selection of intended product must be confirmed to avoid confusion with other injectable solutions.
Issue
There is an unprecedented demand and shortage of neuromuscular blocker (NMB) products in Canada as a result of the COVID-19 pandemic. Given the medical necessity of NMBs, Health Canada has added US-labelled Vecuronium Bromide for Injection 10mg in a fliptop vial (1 mg/mL when reconstituted to 10 mL) to the List of Drugs for Exceptional Importation and Sale.
Vecuronium Bromide, USP is a non-depolarizing NMB agent that is not authorized for use in Canada; however, Health Canada has permitted the exceptional importation and sale of this US-labelled product to mitigate shortages of NMB products in Canada.
Products affected
Vecuronium Bromide Injection (US-labelled)
10 mg in a fliptop vial (1 mg/mL when reconstituted to 10 mL)
Background information
Vecuronium bromide is indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
For information on appropriate use of vecuronium bromide including dosage and administration, please refer to the US Vecuronium Bromide Prescribing Information.
Who is affected
Information for healthcare professionals
This drug should be administered by appropriately trained healthcare professionals familiar with its actions, characteristics, and hazards.
Health Canada is aware of domestic and international reports of NMB mix-ups causing serious harm including death; some of these errors are related to differences in the labelling and packaging of these products.
Please see Appendix A for images of US-Labelled Vecuronium Bromide Injection.
Proper selection of intended product must be confirmed to avoid confusion with other injectable solutions.
For complete product information, please refer to the US Vecuronium Bromide Prescribing Information.
Action taken by Health Canada
The Minister of Health signed the Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in relation to COVID-19. Drugs included on the List of Drugs for Exceptional Importation and Sale referenced in the Interim Order are eligible for the exceptional importation and sale provisions provided for in the Interim Order. Health Canada has added Vecuronium Bromide for Injection to this list, which permits the importation and sale of US-labelled Vecuronium Bromide for Injection.
Health Canada has worked with Pfizer Canada ULC to prepare this alert for Vecuronium Bromide. Health Canada is communicating this important safety information to healthcare professionals and Canadians via the Recalls and Safety Alerts Database on the Healthy Canadians Web Site. This communication update will be further distributed through the MedEffect⢠e-Notice email notification system, as well as through social media channels, including LinkedIn and Twitter.
Report health or safety concerns
Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Any case of serious or unexpected side effects in patients receiving Vecuronium Bromide for Injection should be reported to Pfizer Canada ULC or Health Canada.
Pfizer Canada ULC
17,300 Trans-Canada Highway
Kirkland, QC
H9J 2M5
Telephone: 1-866-723-7111
Fax: 1-855-242-5652
You can report any suspected adverse reactions associated with the use of health products to Health Canada by:
- Calling toll-free at 1-866-234-2345; or
- Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
For other health product inquiries related to this communication, contact Health Canada at:
Marketed Health Product Directorate
E-mail: hc.mhpd-dpsc.sc@canada.ca
Telephone: 613-954-6522
Fax: 613-952-7738
Sincerely,
Original Signed by
Vratislav Hadrava M.D., Ph.D.
Vice President & Medical Director
Pfizer Canada UL
Images
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