Health Product InfoWatch: June 2026

Contents

• Monthly recap of health product safety information
  • Finasteride and Dutasteride
  • Givlaari (givosiran)
  • Tramadol-containing products
  • Unauthorized health products
• Announcement
  • Breast implant recall subscription service
• New health product safety information
  • Health product safety summary
    • 2025 AR data
  • Safety brief
    • Vitamin B6 health products and peripheral neuropathy
• 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 May 2026 by Health Canada.

Finasteride and dutasteride

This safety review evaluated the risk of sexual dysfunction associated with the use of finasteride-containing products and dutasteride-containing products, to identify and assess newly emerging safety information, and to determine whether current risk minimization measures remain appropriate. Health Canada's review, which builds on the evidence that existed at the time of market authorization of finasteride and dutasteride, provides a larger body of evidence on the link between the use of these products and the risk of sexual dysfunction. Health Canada will work with the manufacturers to enhance the product safety information in the Canadian product monograph for all finasteride-containing products and dutasteride-containing products to include a warning about the risk of sexual dysfunction.

• Summary Safety Review: Finasteride and dutasteride

Givlaari (givosiran)

This safety review evaluated the risk of acute pancreatitis associated with the use of Givlaari. Health Canada's review found a possible link. Health Canada will work with the manufacturer to update the Canadian product monograph to include the risk of acute pancreatitis.

• Summary Safety Review: Givlaari (givosiran)

Tramadol-containing products

This safety review evaluated the risk of prolonged, persistent or recurrent hiccups associated with the use of tramadol-containing products. Health Canada's review found a possible link. Health Canada will work with the manufacturers to update the Canadian product monograph of all tramadol-containing products to include the risk of prolonged, persistent or recurrent hiccups.

• Summary Safety Review: Tramadol-containing products

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.

• Type I recall: GHK-Cu & BPC-157 powder (unauthorized active pharmaceutical ingredients)
• Type I recall: Nitrous Oxide Chargers

Announcement

Breast implant recall subscription service

Health Canada has launched a new way for patients, healthcare professionals, and others to register to receive direct alerts about breast implant recalls and safety issues. This new subscription complements Health Canada's existing broader email subscription service for breast implants, which includes other safety information in addition to recall alerts.

Given that healthcare of people with breast implants continues to be of interest to many Canadians, a printable poster is available for health professionals to display in their offices to help inform patients about this service. Learn more about breast implants.

New health product safety information

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

Health product safety summary

Post-market reporting systems help in the identification and analysis of new safety information for health products so that appropriate action can be taken to minimize risks to human health. Adverse reactions (ARs) suspected of being associated with the use of health products can be reported to the Canada Vigilance Program (CVP) in Health Canada, who holds the responsibility of monitoring the safety of health products in Canada. Market authorization holders and hospitals are required to submit AR reports to the CVP. The CVP also receives voluntary reports from community members (consumers, patients, and non-hospital-based healthcare professionals).

This summary contains information about domestic AR cases reported for pharmaceuticals, natural health products, biologics, radiopharmaceuticals, disinfectants, and sanitizers with disinfectant claims, received by the CVP in 2025. These reports are suspected associations, which reflect the reporter's observations and opinions, and do not reflect any Health Canada assessment of association between the health product and the reaction(s).

For more information, contact the Marketed Health Products Directorate.

2025 AR data

• 186,275 reports of ARs in Canada were received by the CVP from January 1 to December 31, 2025. These reports represent 74,818 domestic AR cases.^{Footnote *}
• 77% of cases were classified as serious.
• A case can have more than one reported reason for seriousness. Out of these serious cases:
  • 33% required hospitalization
  • 10% reported a death
  • 4% were life-threatening
• 14 potential safety issues were identified from AR reports for health products received during this period and, for 2 of these, work is ongoing to determine if they are safety signals.
• AR reports received in 2025 also helped support the validation and assessment of safety signals from other sources (e.g., new safety information from foreign regulators and market authorization holders, and medical and scientific literature).

Figure 1: Text description

Figure 1: Distribution of AR cases by reporting source

Reporting source	Percentage	Numbers
Market Authorization Holder	86.4%	64,640
Community	7.1%	5,308
Hospital	6.1%	4,552

Figure 2: Text description

Figure 2: Distribution of AR cases by product type

Product type	Percentage	Numbers
Pharmaceuticals	58.4%	43,670
Biologics	42.7%	31,949
Natural health products	1.4%	1,075
Radiopharmaceuticals	0.9%	640
Other	0.2%	117

Distribution of AR cases by reporter type

• 16% from a physician
• 8% from a pharmacist
• 45% from other health professionals
• 31% from a consumer / other

Distribution of AR cases by patient sex

• 56% female
• 38% male
• 6% unknown

Figure 3: Text description

Figure 3: Distribution of AR cases by patient age group

Age group	Number of serious cases	Number of non serious cases
Unknown	8,600	2,130
Elderly (65 years and above)	19,996	3,736
Adult (19 – 64 years)	26,780	10,875
Adolescent (12 – 18 years)	1,035	359
Child (2-11 years)	893	138
Infant (less than 24 months)	260	16

Safety brief

Vitamin B6 health products and peripheral neuropathy

Vitamin B6 is a naturally occurring, water-soluble vitamin, present in many commonly consumed foods and added to some supplemented/fortified foods. It is also available in health products. In Canada, vitamin B6 health products are regulated as natural health products (NHPs) or as prescription drugs. Vitamin B6 is authorized for use in NHPs to help in energy and nutrient metabolism, tissue formation, red blood cell formation, and to prevent vitamin B6 deficiency.^{Footnote 1} Prescription drugs containing vitamin B6 are typically used for the management of nausea and vomiting in pregnancy or for use before, during, and/or after pregnancy to support nutritional status and reduce risk of nutrient-deficiency related complications.^{Footnote 2 Footnote 3}

Health Canada conducted a review of available information from foreign regulatory agencies, Canadian and international adverse reaction reports, as well as the scientific literature, and found a possible association between vitamin B6-containing NHPs and the risk of peripheral neuropathy, when taken at daily doses of 10 mg or higher. Health Canada's review did not find sufficient evidence to establish an association between vitamin B6-containing prescription drugs and the risk of peripheral neuropathy, despite these products containing similar amounts of vitamin B6 to what is found in NHPs.

For vitamin B6-containing NHPs, Health Canada has updated the Multi-Vitamin/Mineral Supplements Monograph to include information on this risk. Patients taking vitamin B6-containing health products are reminded to review product labels and follow recommended dosing instructions.

Health Canada will continue to monitor the safety of vitamin B6-containing health products, as it does for all health products on the Canadian market, to identify and assess potential harm. Health Canada will take appropriate and timely action should new health risks be identified.

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™ 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