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Health Product InfoWatch: September 2022

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Organization: Health Products and Food Branch
Marketed Health Products Directorate
Health Product InfoWatch Editorial Team

Date published: September 2022
ISSN: 2368-8025
Cat.: H167-1E-PDF
Pub.: 210715

Contents

Health products mentioned in this issue

Pharmaceuticals and biologics

Other

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.

Drug and vaccine authorizations and communications for COVID-19

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

Comirnaty (Pfizer-BioNTech COVID-19 Vaccine)

On September 9, 2022, Health Canada authorized a new presentation of Comirnaty (COVID-19 Vaccine, mRNA), 3 mcg/0.2 mL (DIN 02530325), for use in children aged 6 months to less than 5 years. This new presentation has a MAROON vial cap and MAROON label border. It requires dilution with 2.2 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use.

In addition, as an extraordinary measure to provide access to vaccine supplies in the context of the global pandemic, Pfizer and BioNTech are continuing to provide vaccine supplies with vials and cartons labelled with the name Pfizer-BioNTech COVID-19 Vaccine. This label is presented in English only and is missing some important Canadian-specific information normally found on Health Canada approved labels.

Health Product Risk Communication: Comirnaty (Pfizer-BioNTech COVID-19 Vaccine)

On August 19, 2022, Health Canada authorized a booster dose of Comirnaty for children aged 5 through <12 years of age. A booster dose of Comirnaty (0.2 mL) may be administered intramuscularly at least 6 months after completion of the primary series in individuals 5 through ˂12 years of age.

Authorization with terms and conditions: Comirnaty (Pfizer-BioNTech COVID-19 Vaccine)

Spikevax Bivalent (elasomeran/imelasomeran) COVID-19 Vaccine

On September 1, 2022, Health Canada authorized Spikevax Bivalent (elasomeran/imelasomeran), which targets the original SARS-CoV-2 virus from 2019 and the Omicron (BA.1) variant, for use as a booster dose in individuals 18 years of age or older.

In order to provide rapid access to Spikevax Bivalent, Moderna is distributing product vials and cartons labelled in English only with the brand name “Spikevax 0 (Zero) / O (Omicron)” for a period of time. Important Canadian-specific information is absent from these labels. The bivalent Spikevax 0 (Zero) / O (Omicron), 0.10 mg/mL, 2.5 mL shares the same coloured vial cap (royal blue) to monovalent Spikevax 0.10 mg/mL, 2.5 mL.

Health Product Risk Communication: Spikevax Bivalent (elasomeran/imelasomeran) COVID-19 Vaccine
Authorization with terms and conditions: Spikevax Bivalent (elasomeran/imelasomeran) COVID-19 Vaccine

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 August 2022 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.

Draximage MDP

One lot of Draximage MDP has been recalled because it may contain particulate matter.

Type 1 drug recall: Draximage MDP

Imbruvica (ibrutinib)

Serious and fatal events of cardiac arrhythmia or cardiac failure have occurred in patients treated with Imbruvica. Patients with significant cardiac co-morbidities may be at greater risk for developing these events, including sudden fatal cardiac events. Responding to data from new clinical trials and the ongoing monitoring of product safety, the Canadian product monograph for Imbruvica has been updated to include stronger warnings about these cardiac-related events and new dose modification guidelines.

Health Product Risk Communication: Imbruvica (ibrutinib)

Jamp-Atorvastatin

Jamp Pharma Corporation recalled one lot of Jamp-Atorvastatin 40 mg tablets due to possible contamination with latex pieces during manufacturing. A piece of latex was found in one tablet from the affected lot.

Advisory: Jamp-Atorvastatin

Jamp-Atorvastatin Calcium

Jamp Pharma Corporation recalled one lot of Jamp-Atorvastatin Calcium after one bottle labelled to contain 10 mg tablets of Jamp-Atorvastatin Calcium was found to contain 40 mg tablets of Jamp-Atorvastatin Calcium. Product from the affected lot was sold to pharmacies between May 2022 and August 2022.

Advisory: Jamp-Atorvastatin Calcium

Nexavar (sorafenib)

This safety review evaluated the risk of thrombotic microangiopathy with the use of Nexavar (sorafenib). Health Canada's review concluded that there may be a link. Health Canada will work with the manufacturer to update the Canadian product monograph for Nexavar to include this risk.

Summary Safety Review: Nexavar (sorafenib)

Normosol-R

One lot of Normosol-R solution bags has been recalled, as the bags in the affected lot may be leaking.

Type 1 drug recall: Normosol-R

pms-Hydromorphone

Pharmascience Inc. recalled one lot of pms-Hydromorphone, 2 mg tablets, as the bottles may contain hydromorphone tablets of a different strength (8 mg). Products from the affected lot were sold between May 2022 and August 2022.

Advisory: pms-Hydromorphone

Sodium chloride 23.4% injection

Several lots of Sodium chloride 23.4% injection (Omega Laboratories Limited) have been recalled, as the affected lots may contain glass particles.

Type 1 drug recall: Sodium chloride 23.4% injection

Taro-Zoledronic acid injection

Taro Pharmaceuticals Inc. recalled all lots of Taro-Zoledronic acid injection 5mg/100mL because they may contain particulate matter.

Advisory: Taro-Zoledronic acid injection

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: Counterfeit COVID-19 antigen rapid test kits found in Ontario
Advisory: Counterfeit Viagra and Cialis erectile dysfunction drugs seized from Grace Daily Mart in Scarborough, Ontario
Advisory: Unauthorized health products seized from Productos Latinos El Aguila in Leamington, Ontario
Advisory: Unauthorized products may pose serious health risks

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

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 His Majesty the King 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.

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