Health Product InfoWatch: February 2024
Health Products and Food Branch
Marketed Health Products Directorate
Health Product InfoWatch Editorial Team
ISSN: 2368-8025
Cat.: H167-1E-PDF
Pub.: 230000
Contents
- Health products mentioned in this issue
- Monthly recap of health product safety information
- New health product safety information
- Scope
- Reporting Adverse Reactions
- Helpful links
- Suggestions?
Health products mentioned in this issue
Pharmaceuticals and biologics
Natural and non-prescription health products
Other
Monthly recap of health product safety information
The following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in January 2024 by Health Canada.
Colistin (colistimethate sodium)
This safety review evaluated the risk of pseudo-Bartter syndrome associated with colistin (colistimethate sodium)-containing products. Health Canada’s review of the available information found a link. Health Canada is working with the manufacturers to update the Canadian product monograph for colistin (colistimethate sodium)-containing products with a warning about reported cases of pseudo-Bartter syndrome.
Summary Safety Review: Colistin (colistimethate sodium)
Pediatrix Acetaminophen Oral Solution for children
Teva Canada Ltd. recalled one lot of Pediatrix Acetaminophen Oral Solution after routine product testing found a higher than acceptable amount of acetaminophen in the affected lot (approximately 185mg/5mL rather than the approved and labelled 160mg/5mL).
Advisory: Pediatrix Acetaminophen Oral Solution for children
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 sexual enhancement products
New health product safety information
The following topics have been included to raise awareness and encourage reporting of adverse reactions.
Product monograph update
The following safety labelling update, which was recently made to the Canadian product monograph, has been included 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.
Allergenic Extract Pollens and Allergenic Extract Non Pollens (allergenic extracts for diagnostic use only)
The Warnings and Precautions and Patient Medication Information sections of the Canadian product monograph for Allergenic Extract Pollens and Allergenic Extract Non Pollens marketed by ALK-Abelló Pharmaceuticals, Inc. have been updated with the risk of anaphylaxis following false negative food allergen skin test results.
Key messages for healthcare professionals:Footnote 1
- There have been post-market reports of false negative skin test results, associated with anaphylaxis from subsequent exposure to the allergen.
- Based on the patient’s clinical history, and if there is a high index of suspicion, healthcare providers should confirm negative skin testing with serologic testing by measuring specific serum IgE or with a medically-supervised oral food challenge.
There is currently a stop sale in place for the non-standardized peanut extract and for the non-standardized pecan extract products marketed by ALK-Abelló Pharmaceuticals, Inc.
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
- MedEffectTM 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 Portal
- Drug Shortages Canada
- Medical Device Shortages
- COVID-19 Vaccines and Treatments Portal
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
Reference
- Footnote 1
-
Allergenic Extract Pollens and Allergenic Extract Non Pollens (allergenic extracts for diagnostic use only) [product monograph]. Mississauga (ON): ALK-Abelló Pharmaceuticals, Inc., 2024.
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