Health Product InfoWatch - August 2021

Contents

• Health products mentioned in this issue
• Coronavirus disease (COVID-19)
• Drug and vaccine authorizations and communications for COVID-19
• Product monograph updates for COVID-19 vaccines
  • AstraZeneca COVID-19 Vaccine and COVISHIELD
  • Janssen COVID-19 Vaccine
  • Pfizer-BioNTech COVID-19 Vaccine
• Monthly recap
• Scope
  • Reporting Adverse Reactions
• Helpful links
• Suggestions?
• Copyright

Health products mentioned in this issue

Pharmaceuticals and biologics

AstraZeneca COVID-19 Vaccine
Casirivimab and Imdevimab
COVID-19 Vaccine Moderna
COVISHIELD
Janssen COVID-19 Vaccine
Pfizer-BioNTech COVID-19 Vaccine

Medical devices
CPAP and BiLevel PAP machines and mechanical ventilators
Face masks that contain graphene

Natural and non-prescription health products
Hand sanitizers that may pose health risks
Martin Clinic Liquid Vitamin D
Neutrogena Beach Defense and Ultra Sheer aerosol spray sunscreens

Other
Unauthorized health products

Coronavirus disease (COVID-19)

For the most up-to-date information on COVID-19, please visit the Government of Canada Coronavirus disease (COVID-19) website Canada.ca/coronavirus, which includes a dedicated section for healthcare professionals, and for the health product industry.

The COVID-19 vaccines and treatments portal provides information for consumers, healthcare professionals and researchers on vaccines and treatments authorized for COVID-19, as well as those currently under review.

For information about adverse events following immunization that individuals have reported after receiving a COVID-19 vaccine in Canada, new safety signals or other safety updates, please visit the COVID-19 vaccine safety in Canada webpage. This page is updated weekly.

Drug and vaccine authorizations and communications for COVID-19

Recent communications related to authorized COVID-19 vaccines and treatments are highlighted in this section.

Casirivimab and Imdevimab

Casirivimab and imdevimab, to be administered together, were authorized for the treatment of mild to moderate coronavirus disease 2019 (COVID-19), confirmed by direct SARS-CoV-2 viral testing, in adults and adolescents (12 years of age and older weighing at least 40 kg) who are at high risk for progressing to hospitalization and/or death. To provide earlier access to the product in the context of the global pandemic, Hoffmann-La Roche will distribute one standard global pandemic packaging with English-only labelling.

Health Professional Risk Communication - Casirivimab and Imdevimab

COVID-19 Vaccine Moderna

Further to the Health Canada communication issued on June 14, 2021 (and updated on June 24, 2021), ModernaTx, Inc. is providing one additional lot (016F21A) of US-labelled vaccine supplies with English-only vial and carton labels in order to expedite the distribution of the vaccine in Canada.

Health Professional Risk Communication - COVID-19 Vaccine Moderna

Product monograph updates for COVID-19 vaccines

The following safety labelling updates, which were recently made to the Canadian product monograph, have been selected for your awareness. Canadian product monographs for authorized vaccines and treatments for COVID-19 can be accessed through the COVID-19 vaccines and treatments portal or Health Canada's Drug Product Database.

AstraZeneca COVID-19 Vaccine and COVISHIELD

The Warnings and Precautions, Adverse Reactions (Post-Market Adverse Reactions), and Patient Medication Information sections of the Canadian product monograph for the AstraZeneca COVID-19 Vaccine and COVISHIELD have been updated with the risk of Guillain-Barré Syndrome.

Key messages for healthcare professionals: ^{Footnote 1Footnote 2}

References

Janssen COVID-19 Vaccine

The Warnings and Precautions, Adverse Reactions (Post-Market Adverse Reactions), and Patient Medication Information sections of the Canadian product monograph for Janssen COVID-19 Vaccine have been updated with the risk of Capillary Leak Syndrome, Guillain-Barré Syndrome and Thrombosis with Thrombocytopenia Syndrome. The Contraindications section has also been updated with the risk of Capillary Leak Syndrome.

Key messages for healthcare professionals: ^{Footnote 1}

Reference

Pfizer-BioNTech COVID-19 Vaccine

The Adverse Reactions (Post-Market Adverse Reactions) and Patient Medication Information sections of the Canadian product monograph for the Pfizer-BioNTech COVID-19 Vaccine has been updated to include the risk of facial paralysis / Bell's Palsy. Health Canada has also communicated this information to Canadians.

Key messages for healthcare professionals: ^{Footnote 1}

Advisory - Pfizer-BioNTech COVID-19 Vaccine

Reference

Monthly recap of health product safety information

The following is a list of health product advisories, type I recalls and summaries of completed safety reviews published in July 2021 by Health Canada.

For health product advisories related to COVID-19 vaccines and treatments, please see the Drug and vaccine authorizations and communications for COVID-19 section.

Certain hand sanitizers that may pose health risks

Health Canada advised Canadians that certain hand sanitizers were recalled because they either contained ingredients that were not permitted by Health Canada, were not properly labelled, were unauthorized, or were missing important information.

Advisory - Certain hand sanitizers that may pose health risks

CPAP and BiLevel PAP machines and mechanical ventilators

Philips Respironics has recalled several models of its Continuous Positive Airway Pressure (CPAP) machines, BiLevel Positive Airway Pressure (BiLevel PAP) machines and mechanical ventilators in Canada and internationally. The devices include a foam component that reduces sounds from the device. This foam may degrade into particles which may be inhaled or swallowed by users, or release volatile organic compounds that may be inhaled.

Advisory - CPAP and BiLevel PAP machines and mechanical ventilators

Face masks that contain graphene

Health Canada assessed four models of face masks manufactured by Shandong Shengquan New Materials Co. Ltd. labelled to contain biomass graphene and found no health risks of concern. As a result, sale of these masks can resume in Canada. No other graphene face masks are currently permitted for sale in Canada. If additional graphene masks are permitted for sale, Health Canada will update Canadians.

Advisory - Face masks that contain graphene

Martin Clinic Liquid Vitamin D

All lots of Martin Clinic Liquid Vitamin D were recalled due to incorrect dosing instructions on the label that could lead to taking too much vitamin D. The label is also missing important warnings, including that the product is not for use by children under 12 years of age, and to consult a healthcare professional if taking blood thinners. The product is sold by Martin Clinic and Nutrition Centre online, and at their clinic and supplement store, which is located in Sudbury, Ontario.

Advisory - Martin Clinic Liquid Vitamin D

Neutrogena Beach Defense and Ultra Sheer aerosol spray sunscreens

All lots of Neutrogena Beach Defense and Ultra Sheer children and adult sunscreens, in aerosol spray format, were recalled after testing detected elevated levels of benzene. Frequent and long-term exposure (e.g., through the skin and by inhalation) to elevated levels of benzene may pose serious health risks.

Advisory - Neutrogena Beach Defense and Ultra Sheer aerosol spray sunscreens

Unauthorized health products

Health Canada advised Canadians about various unauthorized health products being sold at retail locations across Canada or online that may pose serious health risks.

Advisory - Multiple unauthorized drugs from Tokyo Beauty in Burnaby, B.C.

Advisory - Various unauthorized health products

Scope

This monthly publication is intended primarily for healthcare professionals and includes information on pharmaceuticals, biologics, medical devices and natural health products. It provides a summary of key health product safety information published in the previous month by Health Canada, as well as a selection of new health product safety information meant to raise awareness. New information contained in this issue is not comprehensive but rather represents a selection of clinically relevant items warranting enhanced dissemination.

Reporting Adverse Reactions

Canada Vigilance Program

Telephone: 1-866-234-2345

Fax or mail: Form available on MedEffect Canada

For more information on how to report an adverse reaction, visit the Adverse Reaction and Medical Device Problem Reporting page.

Helpful links

• MedEffect^TM Canada
• Recalls and Safety Alerts Database
• New Safety and Effectiveness Reviews
• Canada Vigilance Adverse Reaction Online Database
• Drug Product Database
• Medical Devices Active Licence Listing
• Licensed Natural Health Products Database
• The Drug and Health Product Register
• Drug Shortages Canada
• Stop Illegal Marketing of Drugs and Devices
• List of drugs for exceptional importation and sale
• Drug and vaccine authorizations for COVID-19: List of authorized drugs, vaccines and expanded indications
• Reported side effects following COVID-19 vaccination in Canada

Suggestions?

Your comments are important to us. Let us know what you think by reaching us at HC.infowatch-infovigilance.SC@canada.ca

Health Canada
Marketed Health Products Directorate
Address Locator 1906C
Ottawa ON K1A 0K9
Telephone: 613-954-6522
Fax: 613-952-7738

Copyright

^©2021 Her Majesty the Queen in Right of Canada. This publication may be reproduced without permission provided the source is fully acknowledged. The use of this publication for advertising purposes is prohibited. Health Canada does not assume liability for the accuracy or authenticity of the information submitted in case reports.

Adverse reactions (ARs) to health products are considered to be suspicions, as a definite causal association often cannot be determined. Spontaneous reports of ARs cannot be used to estimate the incidence of ARs because ARs remain underreported and patient exposure is unknown.

Due to time constraints relating to the production of this publication, information published may not reflect the most current information.