Health Product InfoWatch: September 2025
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Health Products and Food Branch
Marketed Health Products Directorate
Health Product InfoWatch Editorial Team
ISSN: 2368-8025
Cat.: H167-1E-PDF
Pub.: 250000
Contents
- Monthly recap of health product safety information
- Scope
- Reporting Adverse Reactions
- Helpful links
- Contact us
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 August 2025 by Health Canada.
Copaxone (glatiramer acetate) and other glatiramer acetate products
Although uncommon, glatiramer acetate can cause anaphylactic reactions, which may be fatal and can occur at any time during treatment, from as early as after the first dose, or even months, up to years, after initiation of treatment. Symptoms of anaphylactic reactions may be similar to and may overlap with those of common immediate post-injection reactions. However, anaphylactic reactions generally appear within one hour of glatiramer acetate administration and are typically more severe, worsen over time and require treatment. The Canadian product monograph (CPM) for Copaxone has been updated to include this information and Health Canada is working with the manufacturers of other glatiramer acetate products to update their respective CPMs.
Crysvita (burosumab)
Crysvita (burosumab) may increase the risk of severe hypercalcemia in patients with underlying tertiary hyperparathyroidism and other risk factors, such as prolonged immobilization, dehydration, hypervitaminosis D, or renal impairment. The Canadian product monograph for Crysvita has been updated to include this information.
Prescription opioids
This safety review evaluated the risk of esophageal dysfunction with long-term use of prescription opioids (buprenorphine, butorphanol, codeine, diamorphine, fentanyl, hydrocodone, hydromorphone, meperidine, methadone, morphine, nalbuphine, normethadone, oxycodone, tapentadol and tramadol). Health Canada's review found a possible link. Health Canada will work with the manufacturers to update the Canadian product monographs for prescription opioids to include this risk.
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: Fake (counterfeit) Cialis and Viagra seized from Toronto, Pickering, and Brantford stores
- Advisory: Unauthorized injectable peptide drugs seized and sold by Canada Peptide
- Advisory: Unlicensed Mitolux UV sunlamps for Vitamin D
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
- Glossary of Fields in the 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
Contact us
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