Health Product InfoWatch – August 2022

Contents

• Health products mentioned in this issue
• Coronavirus disease (COVID-19)
• Monthly recap of health product safety information
• New health product safety information
  • Product monograph updates:
    • Mifegymiso (mifepristone and misoprostol)
    • Direct-acting antivirals containing a protease inhibitor
  • Notice of market authorization with conditions:
    • Lynparza (olaparib)
• Scope
• Reporting Adverse Reactions
• Helpful links
• Suggestions?
• Copyright

Health products mentioned in this issue

Pharmaceuticals and biologics

Apo-Acyclovir
Cholinesterase inhibitors
Imvamune Vaccine
Lynparza (olaparib)
Maviret (glecaprevir, pibrentasvir)
Mifegymiso (mifepristone and misoprostol)
Vosevi (sofosbuvir, velpatasvir, voxilaprevir)
Zepatier (elbasvir, grazoprevir)

Medical devices

CPAP and BiLevel PAP machines and mechanical ventilators

Natural and non-prescription health products

Hand sanitizers that may pose health risks
Magnesium citrate oral solution saline laxatives

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.

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.

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 2022 by Health Canada.

Apo-Acyclovir

Apotex Inc. recalled 4 additional lots of Apo-Acyclovir (acyclovir) tablets, in 200 mg and 800 mg strengths, due to the presence of a nitrosamine impurity (N-nitrosodimethylamine [NDMA]) above or close to the acceptable level.

Advisory: Apo-Acyclovir

Cholinesterase inhibitors

This safety review evaluated the risk of QT interval prolongation and torsade de pointes with the use of cholinesterase inhibitors (donepezil-, rivastigmine- and galantamine-containing products). Health Canada's review of the available information supported a link. Health Canada will work with the manufacturers of all cholinesterase inhibitors to strengthen the information in the Canadian product monographs about the risk of QT interval prolongation and torsade de pointes.

Summary Safety Review: Cholinesterase inhibitors

CPAP and BiLevel PAP machines and mechanical ventilators

Health Canada provided an update on the progress of Philips Respironics' (Philips) recall of several models of CPAP and BiLevel PAP machines and mechanical ventilators in Canada. The Department is closely monitoring the company's progress in resolving the safety issue and implementing a repair and replacement program for affected devices in Canada. Health Canada's safety recommendations have not changed from its July 2021 advisory.

Advisory: CPAP and BiLevel PAP machines and mechanical ventilators

Hand sanitizers that may pose health risks

Health Canada advised Canadians that certain hand sanitizers were recalled due to various safety-related issues, including the presence of ingredients that were not permitted by Health Canada, improper labelling, unauthorized products, and missing safety information.

Advisory: Hand sanitizers that may pose health risks

Imvamune Vaccine

The Imvamune Vaccine expiry date depends on storage temperature. The product monograph indicates: "Store frozen at -20°C ± 5°C or -50°C ± 10°C or -80°C ± 10°C" and does not provide additional information on shelf life if the vaccine is moved between different storage temperatures. Data was submitted to Health Canada characterizing shelf life for alternative storage conditions for Imvamune. Healthcare professionals are advised that Imvamune Vaccine storage conditions and shelf life have been updated to reflect that Imvamune Vaccine vials can be stored at -20°C for up to 3 months following long term storage at -80°C. The initially assigned expiry date for storage at -80°C will become invalid.

Health Product Risk Communication: Imvamune Vaccine

Magnesium citrate oral solution saline laxatives

Health Canada advised that all lots of Equate (lemon flavour), Life Brand (lemon and cherry flavours) and Personnelle (lemon flavour) Magnesium citrate oral solution saline laxatives are being recalled due to the possibility of microbial contamination.

Advisory: Magnesium citrate oral solution saline laxatives

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: Unauthorized products may pose serious health risks
Advisory: Buying health products online? Know the risks

New health product safety information

The following topics have been selected to raise awareness and encourage reporting of adverse reactions.

Product monograph updates

The following safety labelling updates, which were recently made to the Canadian product monographs, have been selected for your awareness. A complete list of safety labelling updates for pharmaceuticals is available on Health Canada's Product monograph brand safety updates page. Canadian product monographs can be accessed through Health Canada's Drug Product Database.

Mifegymiso (mifepristone and misoprostol)

The Serious Warnings and Precautions Box, Warnings and Precautions, Adverse Reactions, and Patient Medication Information sections of the Canadian product monograph for Mifegymiso have been updated with the risk of serious/severe skin reactions, including toxic epidermal necrolysis and acute generalised exanthematous pustulosis.

Maviret (glecaprevir, pibrentasvir), Vosevi (sofosbuvir, velpatasvir, voxilaprevir), and Zepatier (elbasvir, grazoprevir)

The Warnings and Precautions, Adverse Reactions (Post-Market Adverse Reactions) and Patient Medication Information sections of the Canadian product monographs for Maviret, Vosevi, and Zepatier have been updated with the risk of hepatic decompensation and hepatic failure.

Notice of market authorization with conditions

A Notice of Compliance with Conditions (NOC/c) is a form of market authorization with conditions granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada. Communicating a NOC/c is intended to raise awareness on the details of the drug and the type of authorization granted.

Healthcare professionals are encouraged to report to Health Canada any adverse reactions suspected of being associated with marketed health products, including drugs authorized under the NOC/c policy.

The content of these notices reflects current information at the time of publication. Conditions associated with the NOC/c will remain until they have been fulfilled and authorized by Health Canada. For the most up-to-date information, consult Health Canada's NOC database.

Lynparza (olaparib): Authorization with conditions

Health Canada has issued a Notice of Compliance, under the NOC/c policy for a new indication for Lynparza (olaparib), tablets, 100 mg and 150 mg, oral. The new indication for Lynparza is for adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Patients must have confirmation of germline BRCA mutation before Lynparza treatment is initiated. Patients should be advised of the conditional market authorization for this indication.

For the complete prescribing information and information available for patients/caregivers, please consult the Lynparza Canadian product monograph. The product monograph can be accessed through Health Canada's Drug Product Database, the AstraZeneca Canada Inc. website or by contacting AstraZeneca Canada Inc. at 1-800-668-6000. Contact the company for a copy of any references, attachments or enclosures.

*Lynparza's updated product monograph with this NOC/c indication is dated August 2022.

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:

infowatch-infovigilance@hc-sc.gc.ca

Health Product InfoWatch Editorial Team
Marketed Health Products Directorate
Health Canada
Address Locator 1906C
Ottawa ON K1A 0K9
Telephone: 613-954-6522
Teletypewriter: 1-800-465-7735 (Service Canada)

Copyright

© 2022 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.