Summary of key health product safety information from Health Canada InfoWatch newsletter

by Global Pharmacovigilance Team
March 29, 2021
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Summary of key health product safety information from Health Canada InfoWatch newsletter

This is a monthly publication and is intended primarily for healthcare professionals and includes information on pharmaceuticals, biologics, medical devices, and natural health products.

Health Canada Infowatch newsletter 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.

Table of Contents

Summary of key health product safety information from Health Canada InfoWatch newsletter

AstraZeneca COVID-19 Vaccine: Authorization with terms and conditions

Health Canada has authorized with terms and conditions, under the Interim Order, AstraZeneca COVID-19 Vaccine (ChAdOx1-S [recombinant]), solution for intramuscular injection, multiple dose vial (contains 8 doses of 0.5 mL and 10 doses of 0.5 mL) for use in relation to COVID-19.

AstraZeneca COVID-19 Vaccine is indicated for active immunization of individuals 18 years of age and over for the prevention of coronavirus disease 2019 (COVID-19).

For More information @Click here

AstraZeneca COVID-19 Vaccine: Statement

Health Canada confirmed that the benefits of the AstraZeneca COVID-19 Vaccine in protecting Canadians from COVID-19 continue to outweigh the risks.

Health Canada has assessed the available data on the reported events and has determined that the AstraZeneca vaccine has not been associated with an increase in the overall risk of blood clots.

For More information @Click here

COVISHIELD COVID-19 Vaccine: Authorization with terms and conditions

Health Canada has authorized with terms and conditions, under the Interim Order, COVISHIELD COVID-19 Vaccine (ChAdOx1-S [recombinant]), solution for intramuscular injection, multiple dose vial (contains 10 doses of 0.5 mL) for use in relation to COVID-19.

COVISHIELD is indicated for active immunization of individuals 18 years of age and over for the prevention of coronavirus disease 2019 (COVID-19).

For More information @Click here

Janssen COVID-19 Vaccine: Authorization with terms and conditions

Health Canada has authorized with terms and conditions, under the Interim Order, Janssen COVID-19 Vaccine, SARS-CoV-2 Vaccine [Ad26.COV2.S, recombinant], suspension for intramuscular injection, multiple dose vial (contains 5 doses of 0.5 mL) for use in relation to COVID-19.

Janssen COVID-19 Vaccine is indicated for active immunization for the prevention of coronavirus disease-2019 (COVID-19) caused by SARS-CoV-2 virus in individuals 18 years of age and older.

For More information @Click here

Pfizer-BioNTech COVID-19 Vaccine: Update

The Pfizer-BioNTech COVID-19 Vaccine product monograph has been updated to reflect alternative and more flexible storage and/or transportation conditions of the frozen vials and transportation conditions of the thawed undiluted vials.

Unintentional exposure of young children to adult acetaminophen tablets may pose serious health risks

Product: Adult acetaminophen easy-to-swallow tablets.

Issue: There have been multiple incidents of acetaminophen poisoning in young children due to unintentional exposure to adult acetaminophen easy-to-swallow tablets. Acetaminophen overdose poses a high risk of liver damage.

What to do: Parents and caregivers are encouraged to select child-resistant packaging and to make sure that the cap is properly closed after each use. These products should be stored in a locked box, container or cabinet, out of the sight and reach of children. If you think your child has taken adult acetaminophen tablets, call your provincial poison control centre right away. Report any health product adverse events to Health Canada.

For more information @click here

Summary Safety Review – Ceftriaxone-containing products – Health Canada

Ceftriaxone is a prescription antibiotic drug authorized for sale in Canada to treat a wide range of bacterial infections in many different parts of the body or to prevent infections during surgery.
Health Canada reviewed the potential risk of encephalopathy, a disease that affects the brain leading to changes in the way the brain works. This review was triggered by a study published in the Journal of the Neurological Sciences.
Health Canada’s review of the available information concluded that there is a possible link between the use of ceftriaxone and the risk of encephalopathy.
Health Canada will work with the manufacturers of ceftriaxone-containing products to update the Canadian product safety information to include the risk of encephalopathy.

For more information @clcik here

Recall of certain hand sanitizers that may pose health risks

Product: Hand sanitizers that may pose health risks.

Issue: Certain hand sanitizers are being recalled because they do not meet Health Canada’s requirements.

What to do: Stop using the identified product lots below. Consult your health care professional if you have used any of these products and have health concerns. Report any health product adverse events or complaints to Health Canada. See the additional information on buying health products safely in the links below.

For more information @ Click here

COVID-19 Vaccine Moderna: Updated English-only Global Vial and Carton Labels and Post-Market Adverse Reaction Information

The COVID-19 Vaccine Moderna (mRNA-1273 SARS-CoV-2 vaccine) Product Monograph (PM) has been updated with post-market adverse reaction information identified during pharmacovigilance activities. Anaphylaxis has been reported following COVID-19 Vaccine Moderna administration outside of clinical trials. This new information does not change the benefit-risk profile of this product.
The COVID-19 Vaccine Moderna PM and global English-only vial and carton labels are also being updated with new product labelling information, including brand name change. These product labelling updates are administrative in nature (see table under Information for healthcare professionals section and Appendix A).
There are no changes to the product and COVID-19 Vaccine Moderna remains the same in all aspects as initially authorized by Health Canada (i.e., formulation, strength, route of administration, storage and handling) and should be used in Canada for the same indication and per the same vaccination schedule.
The updated PM, which is available in French and English on Health Canada’s Drug Product Database, the federal government’s covid-vaccine.canada.ca website or at www.ModernaCovid19Global.com should be used for complete product information. Updated vial and carton labels with English-only labelling (see Appendix A) are also available on the federal government’s covid-vaccine.canada.ca website.

For more info @ Click here

Unauthorized hand sanitizers and hard surface disinfectants sold by Protegel Quebec Inc. and Hangel Canada Inc. may pose health risks

Product: Unauthorized hand sanitizers and hard surface disinfectants by Protegel Quebec Inc. and Hangel Canada Inc.

Issue: Health Canada is warning Canadians that Protegel Quebec Inc. and Hangel Canada Inc. are selling unauthorized hand sanitizers and hard surface disinfectants online that may pose health risks.

What to do: Stop using these products immediately. Consult your health care professional if you have used this product and have any concerns. Keep all hand sanitizers out of the reach of children. If swallowed, call a poison control centre or get medical help right away. Report any health product adverse events or complaints to Health Canada.

For more info @ Click here

Pfizer-BioNTech COVID-19 Vaccine: Updated Dosage and Administration and Post-Market Adverse Reaction Information

The Pfizer-BioNTech COVID-19 Vaccine Product Monograph (PM) and vial and carton labels are being updated to reflect an increase in the number of doses that can be extracted from each vial, from 5 doses per vial to 6 doses. This global label update to 6 doses has been implemented to minimize vaccine wastage and facilitate access to the vaccine supply during the pandemic.
It is possible to extract a 6th dose of 0.3 mL of the diluted vaccine using low dead-volume syringes and/or needles. In order to ensure consistent withdrawal of 6 doses of 0.3 mL, it is important to minimize volume loss during dose extractions.
If standard syringes and needles are used, there may not be sufficient volume to extract a 6th dose. Excess vaccine from multiple vials should not be pooled to create extra doses.
The PM has also been updated with post-market adverse reaction information identified during pharmacovigilance activities. Severe allergic reactions, including anaphylaxis, have been reported during mass vaccination outside of clinical trials. This new information does not change the benefit-risk profile of this product.
The updated PM, which is available in French and English on Health Canada’s Drug Product Database, the federal government’s covid-vaccine.canada.ca website or at pfizer.ca and CVDvaccine.ca, should be used for complete product information. Updated vial and carton labels with English-only labelling are also available on the federal government’s covid-vaccine.canada.ca website or at CVDvaccine.ca.

For more info @Click here

Ranitidine products recalled because of a nitrosamine impurity

Who are affected: Consumers and patients who are taking a ranitidine drug. Click here for More information

Summary Safety Review – Tecentriq (atezolizumab) – Assessing the Potential Risk of Autoimmune Hemolytic Anemia

Tecentriq (atezolizumab) is a prescription drug authorized for sale in Canada, to be used alone or in combination with other drugs, for the treatment of certain types of lung and liver cancer. It is also authorized with conditions on the manufacturer to treat certain types of breast and bladder cancer.
Health Canada reviewed the potential risk of autoimmune hemolytic anemia (AIHA) with the use of Tecentriq. This review was triggered by safety information from clinical trials and from scientific literature suggesting a link between the use of Tecentriq and AIHA.
Health Canada’s review concluded that there may be a link between the use of Tecentriq and the risk of AIHA.
Health Canada is working with the manufacturer of Tecentriq to update the Canadian product safety information to include a warning for the risk of AIHA.

For More information @ Click here

Health Product InfoWatch – March 2021

Full new letter@ Summary of key health product safety information from Health Canada InfoWatch newsletter

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