Health Product InfoWatch: July 2026

Contents

• Monthly recap of health product safety information
  • Finasteride and dutasteride
  • Ifosfamide for Injection
  • Unauthorized health products
• Announcement
  • Health Canada News: Ministerial Reliance Order
• New health product safety information
  • Vaccine safety summary
    • 2025 AEFI data
  • Safety brief
    • Carbamazepine and oxcarbazepine oral suspensions and the risk of propylene glycol toxicity in neonates and young children
• 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 June 2026 by Health Canada.

Finasteride and dutasteride

This safety review evaluated the known risk of suicidal ideation associated with finasteride to assess new safety information, the potential risk of suicidal ideation with dutasteride, and the possible relationship between sexual dysfunction and suicidal ideation associated with the use of finasteride- and dutasteride-containing products. Based on the review, Health Canada continues to find a link between the use of finasteride and the risk of suicidal ideation. It was determined that the existing Canadian product monographs (CPMs) for all finasteride-containing products are appropriately labelled for this risk and no updates are needed at this time. Health Canada’s review found limited evidence describing a possible link between the use of dutasteride and the risk of suicidal ideation. However, given that dutasteride works in the same way as finasteride, a precautionary approach is warranted. Therefore, Health Canada is working with the manufacturers to update the CPMs for all dutasteride-containing products to include a warning about the risk of suicidal ideation. Despite reports of patients experiencing both sexual dysfunction and suicidal ideation while using finasteride or dutasteride, a conclusion on the relationship between these two adverse events could not be confirmed due to the complexity of the evidence and the presence of confounders.

Summary Safety Review: Finasteride and dutasteride  

Ifosfamide for Injection

Due to a critical shortage of IFEX (Ifosfamide for Injection), 1 g and 3 g per vial in Canada, and given the medical necessity of this drug, Health Canada has permitted the exceptional, temporary importation and sale of Chinese-authorized Ifosfamide for Injection, 1 g per vial with Chinese-only labels. Healthcare professionals should be aware of important differences between the Chinese-authorized and Canadian-authorized products.

Health Product Risk Communication: Ifosfamide for 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: Unauthorized soft-shelled hyperbaric chambers

Announcement

Health Canada news: Ministerial Reliance Order

Health Canada’s Ministerial Reliance Order has been published in the Canada Gazette, Part II and came into force on July 15, 2026. The Ministerial Reliance Order is an important deliverable under Health Canada’s Report on Red Tape Reduction. The Order allows the Department to rely on decisions or documents produced by comparable Foreign Regulatory Authorities (FRAs) when reviewing certain drug submissions. This approach helps to reduce duplication, and supports earlier access to drugs for Canadians while maintaining Health Canada’s requirements for safety, efficacy and quality. The Ministerial Reliance Order applies only to defined classes of drugs and designated comparable FRAs listed in an incorporated-by-reference (IbR) document.

• IbR list of classes of drugs and foreign regulatory authorities for reliance: Human drugs
• IbR list of classes of drugs and foreign regulatory authorities for reliance: Veterinary drugs

The first classes of drugs that will be accepted by Health Canada under the Ministerial Reliance Order include human drugs for pediatric use and veterinary drugs.

Health Canada is seeking feedback from stakeholders on the draft guidance, which describes the regulatory requirements of the Ministerial Reliance Order and the submission process. This consultation is open until September 12, 2026.

Further information can be found on Health Canada’s new Ministerial Reliance Order web page.

New health product safety information

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

Vaccine safety summary

Health Canada and the Public Health Agency of Canada (PHAC) share the responsibility of monitoring the safety of vaccines in Canada. Market authorization holders are required to report serious adverse events following immunization (AEFIs) to the Canada Vigilance Program (CVP) in Health Canada. The CVP also receives voluntary reports from healthcare professionals and consumers. While hospitals must report serious adverse drug reactions that were documented within their facility, they do not have to report an adverse reaction to a vaccine if they have submitted an AEFI report on that case to their local public health unit. These reports are submitted by provincial and territorial public health authorities to the Canadian Adverse Events Following Immunization Surveillance System in PHAC. Reports received by the Canadian Adverse Events Following Immunization Surveillance System are not included in the analysis below.

For more information, contact the Marketed Health Products Directorate.

2025 AEFI data

• 879 reports of AEFIs were received by the CVP from January 1 to December 31, 2025, for preventive vaccines marketed in Canada.
• 54% of reports were classified as serious
• A report can have more than one reason for seriousness listed. Out of these serious reports:
  • 12.3% required hospitalization
  • 2.6% were life-threatening
  • 1.4% reported a death^{Footnote aFootnote b}

Distribution of reports by reporter type

• 9% from a physician
• 17% from a pharmacist
• 13% from other health professionals
• 61% from a consumer / other

Distribution of reports by patient sex

• 66% female
• 27% male
• 7% unknown

Figure 1: Text description

Age group	Number of serious cases	Number of non serious cases
Unknown	87	12
Other	1	0
Elderly (65 years and above)	178	74
Adult (19 - 64 years)	178	313
Adolescent (12 - 18 years)	13	4
Child (2 - 11 years)	6	4
Infant (28 days to 23 months)	8	1

Figure 2: Text description

Vaccine Types		Number of serious reports	Number of non-serious reports
Herpes Zoster	HZ	130	285
COVID-19	COVID	174	15
Pneumococcal	PNEU	31	18
Hepatitis B	HB	3	29
Influenza	INF	28	10
Respiratory syncytial virus	RSV	29	7
Influenza/COVID-19Figure 2 Footnote *	INF/COVID	21	1
Hepatitis A and Hepatitis B	HAHB	12	8
Measles, Mumps, Rubella	MMR	5	9
Human papillomavirus	HPV	8	5
Figure 2 Footnote * Refers to reports that include both an influenza vaccine and a COVID-19 vaccine as suspects. Figure 2 Return to footnote * referrer

Key findings:

• Herpes zoster vaccines: The most frequently reported AEFIs were related to herpes zoster infection [42; other terms included post-herpetic neuralgia (6), herpes zoster oticus (2), herpes ophthalmic (1), herpes zoster disseminated (1)], vaccination failure (38), fatigue (8), pain and rash (6 each), and pyrexia (5).
• COVID-19 vaccines: The most frequently reported AEFIs were fatigue (22), pain (21), headache (20), COVID-19 infection (20), drug ineffective (14), and myalgia (18).
• Pneumococcal vaccines: The most frequently reported AEFIs were arthralgia (10), pain in extremity (9), pruritus (9), pyrexia (8), and nasopharyngitis (8).

Note that because of updated information received by the Canada Vigilance Program, there may be differences in the number of reports and adverse events retrieved at different dates.

Safety brief

Carbamazepine and oxcarbazepine oral suspensions and the risk of propylene glycol toxicity in neonates and young children

Carbamazepine and oxcarbazepine are prescription anticonvulsants authorized by Health Canada for the treatment of certain forms of epilepsy in individuals 6 years of age and older. Carbamazepine is also authorized for additional indications.

Carbamazepine oral suspension (100 mg/5 mL) is currently available as both a brand name^{Reference 1} and generic product^{Reference 2}, while oxcarbazepine oral suspension (60 mg/mL) is currently available as a single brand name product.^{Reference 3}

Although carbamazepine and oxcarbazepine oral suspensions are not authorized for use in children younger than 6 years of age, they have been used off-label in neonates and young children for certain seizure disorders. This off-label use may increase the risk of toxicity because both products contain the excipient propylene glycol at levels that could exceed the recommended safety thresholds for these age groups.

Propylene glycol is a common excipient used in a variety of drugs to improve the solubility of the active ingredient and preserve liquid formulations. After oral administration, propylene glycol is rapidly and completely absorbed. Although generally well tolerated in older children and adults, neonates and young children have a reduced capacity to metabolize and eliminate propylene glycol due to immature hepatic and renal function, leading to accumulation. This limitation is much more pronounced in neonates.^{Reference 4}

Carbamazepine oral suspension products contain propylene glycol at concentrations ranging from 25.0 to 51.2 mg/mL, while oxcarbazepine oral suspension contains propylene glycol at a concentration of 25 mg/mL. Term neonates younger than 4 weeks of age and preterm neonates with a post-menstrual age under 44 weeks are at increased risk of propylene glycol accumulation and toxicity when exposure exceeds 1 mg/kg/day, a threshold surpassed by typical neonatal daily doses of either suspension. In children 1 month to 5 years of age, cumulative propylene glycol exposure of 50 mg/kg/day or more is associated with an increased risk of accumulation and toxicity.

Exposure to other medications containing propylene glycol above the daily exposure thresholds may also result in toxicity. Use of multiple products that individually contain low levels of propylene glycol may lead to clinically relevant cumulative exposure. Concurrent exposure to other substances metabolized by alcohol dehydrogenase, such as ethanol, may also increase the risk of propylene glycol accumulation by reducing its clearance through competition for the same metabolic pathway.

Propylene glycol accumulation can lead to serious adverse reactions including, but not limited to, metabolic acidosis, acute kidney injury (including acute tubular necrosis), and liver dysfunction.  

Healthcare professionals are encouraged to report any adverse reactions suspected of being associated with propylene glycol-containing products, including carbamazepine and oxcarbazepine oral suspension products, to the Canada Vigilance Program. Health Canada will continue to monitor the safety of health products on the Canadian market and 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

References