Insights on Health Products: October 2024 Edition

Health Canada is participating in the World Health Organization’s annual #MedSafetyWeek social media initiative to encourage the reporting of adverse reactions (ARs) from November 4 to 10, 2024.

Adverse reactions play a major role in global healthcare challenges, impacting morbidity and mortality rates. When health products receive market authorization, they are typically evaluated for short-term safety and efficacy among a small, controlled group of individuals. Insights into health product safety grow as these products are used by larger populations, for extended periods, and in varied conditions. Therefore, it is vital for healthcare providers to report ARs to Health Canada’s Canada Vigilance Program. Enhanced reporting supports the Department’s post-market surveillance efforts and ensures the ongoing assessment of product benefits against potential risks.

Moreover, Health Canada works with global drug safety monitoring entities, including the World Health Organization’s Program for International Drug Monitoring, to exchange safety information from AR reports.

For further details about the #MedSafetyWeek initiative, keep an eye on Health Canada’s social media profiles starting November 4, 2024:

Monthly Summary of Health Product Safety Information

Below is a compilation of health product advisories, type I drug recalls, and summaries of concluded safety reviews released by Health Canada in September 2024.

JAMP-Clopidogrel and AG-Clopidogrel

JAMP Pharma Corporation and Angita (AG) Pharma Inc. have issued a recall for all batches of JAMP-Clopidogrel and AG-Clopidogrel 75 mg tablets due to potential weight discrepancies, which may lead to unintentional lower or higher dosages for patients.

Advisory: JAMP-Clopidogrel and AG-Clopidogrel
Type I drug recall: JAMP-Clopidogrel
Type I drug recall: AG-Clopidogrel

M-Eslon (morphine sulfate)

Ethypharm Inc. has recalled one batch of M-Eslon (morphine sulfate) extended release (ER) capsules because some containers marked as M-Eslon 30 mg ER may actually contain 60 mg capsules, risking potential overdosing for patients prescribed the lower dosage.

Advisory: M-Eslon (morphine sulfate)
Type I drug recall: M-Eslon (morphine sulfate)

Olanzapine

Health Canada has evaluated the potential risks linked to the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) and hyponatremia associated with olanzapine usage. Although a concrete correlation could not be established, the review indicates the risk cannot be ruled out. Health Canada plans to collaborate with manufacturers for necessary updates to the Canadian product monograph for all olanzapine products regarding these risks.

Safety Summary Review: Olanzapine

Panhematin (hemin for injection)

A recall has been issued for one batch of Panhematin 268 mg/vial powder for solution due to concerns regarding sterility in the affected batch.

Type I drug recall: Panhematin (hemin for injection)

Refresh Lacri-Lube eye ointment

AbbVie Corporation of Canada has recalled all lots of Refresh Lacri-Lube eye ointment owing to some tubes potentially leaking, which raises the risk of bacterial contamination and ensuing infections.

Advisory: Refresh Lacri-Lube eye ointment

Unauthorized Health Products

Canadians have been alerted about several unauthorized health products being sold in stores nationwide or online, presenting potential health hazards.

Advisory: Unauthorized sexual enhancement products

New Health Product Safety Information

The following subjects aim to enhance awareness and stimulate AR reporting efforts.

Updates to Product Monographs

Recent updates to the safety labeling included in Canadian product monographs are important for your information. A full list of these updates for pharmaceuticals can be located on Health Canada’s Product monograph brand safety updates page. Canadian product monographs can be found in Health Canada’s Drug Product Database.

Leqvio (inclisiran)

The Instructions for Use and Handling (For Healthcare Professionals) section in the Canadian product monograph for Leqvio has been modified to help mitigate the risk of needle clogging, which can prevent proper injection.

Key Messages for Healthcare Professionals:Reference 1

  • Do not remove the needle cap until ready to inject.
  • Removing the needle cap too early before injection may cause the drug in the needle to dry, leading to clogging.
  • If unable to depress the plunger post-insertion, use a new pre-filled syringe.

Provera and Depo-Provera (medroxyprogesterone acetate)

Updates in the Warnings and Precautions and Patient Medication Information sections of the Canadian monographs for Provera and Depo-Provera now include the risk of meningioma.

Key Messages for Healthcare Professionals:Reference 2Reference 3

  • Meningiomas have been reported following extended use of progestins, including medroxyprogesterone acetate (MPA).
  • In case of a meningioma diagnosis, MPA should be discontinued.
  • Exercise caution when suggesting medroxyprogesterone to patients with previous meningioma cases.

Zeposia (ozanimod)

Revisions in the Warnings and Precautions and Adverse Reactions sections of the Canadian product monograph for Zeposia now detail the risk of liver damage and acute liver failure.

Key Messages for Healthcare Professionals:Reference 4

  • Clinically significant liver injury and acute liver failure resulting in liver transplants have occurred in patients treated with Zeposia post-marketing.
  • Indicators of liver damage, which include elevated liver enzymes and bilirubin levels, have manifested as early as 10 days post-initial dose.
  • During Zeposia treatment, monitor liver function by evaluating liver enzyme and bilirubin levels at months 1, 3, 6, 9, and 12 from treatment initiation, and at regular intervals thereafter.

Scope

This publication is targeted mainly at healthcare professionals and encompasses pharmaceuticals, biologics, medical devices, and natural health products. It summarizes crucial health product safety information published by Health Canada in the past month, alongside relevant new safety updates encouraging awareness. The information in this issue is not exhaustive but reflects clinically significant items requiring increased dissemination.

Reporting Adverse Reactions

Canada Vigilance Program
Telephone: 1-866-234-2345
Fax or mail: Form available on MedEffect Canada

For additional details on reporting an adverse reaction, please visit the Adverse Reaction and Medical Device Problem Reporting page.

Useful Links

Contact Us

Your feedback is pivotal to us. Please share your thoughts by contacting 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

Reference 1

Leqvio (inclisiran injection) [product monograph]. Montreal (QC): Novartis Pharmaceuticals Canada Inc.; 2024.

Return to reference 1

Reference 2

Provera (medroxyprogesterone acetate tablets) [product monograph]. Kirkland (QC): Pfizer Canada ULC, 2024.

Return to reference 2

Reference 3

Depo-Provera (medroxyprogesterone acetate injectable suspension) [product monograph]. Kirkland (QC): Pfizer Canada ULC, 2024.

Return to reference 3

Reference 4

Zeposia (ozanimod) [product monograph]. Saint-Laurent (QC): Bristol-Myers Squibb Canada; 2024.

Return to reference 4