Health Product Insights Report: June 2024
Contents
Monthly Overview of Health Product Safety Alerts
Below is a summary of health product advisories, type I drug recalls, and summaries from completed safety evaluations made by Health Canada in May 2024.
Iodinated Contrast Medium
A safety review focused on assessing the likelihood of hypothyroidism due to iodinated contrast medium in children younger than 3 years old. Health Canada’s findings suggest a possible risk of hypothyroidism for this demographic. The agency intends to collaborate with manufacturers to revise the Canadian product monograph for all iodinated contrast mediums to include further risk details and monitoring guidelines for affected children.
Summary Safety Review: Iodinated contrast medium
JAMP Digoxin
JAMP Pharma Corporation has issued a recall for a specific batch of JAMP Digoxin 0.0625 mg tablets due to the potential presence of larger-than-normal tablets. Patients consuming these oversized tablets may accidentally experience an increased dose which could lead to severe health complications, including the risk of overdose.
Type 1 drug recall: JAMP Digoxin
Nexavar (sorafenib)
This review examined the potential for tumour lysis syndrome associated with Nexavar. Health Canada’s investigation found a possible correlation. The agency is coordinating with the manufacturer to amend the Canadian product monograph for Nexavar to reflect this identified risk.
Summary Safety Review: Nexavar (sorafenib)
Reddy-Sapropterin
A recall has been initiated for one batch of Reddy-Sapropterin 100mg powder for solution, due to the risk of unpredicted colour change, which could potentially lead to reduced effectiveness.
Type 1 drug recall: Reddy-Sapropterin
Unauthorized Health Products
Health Canada has alerted the public about a variety of unauthorized health products being sold in retail settings or online that may pose significant health risks.
Advisory: Fake Viagra and Cialis drugs seized from Petro Canada in Vineland, ON
Advisory: Unauthorized sexual enhancement products
Advisory: Unauthorized UMARY Hyaluronic Acid Dietary Supplement
New Health Product Safety Information
This section highlights topics designed to enhance awareness and promote reporting of adverse reactions.
Safety Briefs
False-positive HIV Test Results in CAR-T Cell Therapy Patients
Devices utilizing nucleic acid testing (NAT) can identify viral genetic components, specifically for Human Immunodeficiency Virus (HIV). As per Health Canada, HIV NAT devices in Canada aim to detect HIV RNA, typically for blood and tissue screening, as well as other clinical applications. There’s a concern that patients undergoing lentivirus-based CAR T-cell therapy could receive false-positive HIV results due to the genetic similarities between the therapy and the virus. This could result in delays for tissue transplant eligibility confirmations.
Important Notes for Healthcare Providers:
- Instances of false-positive HIV NAT results have been documented in patients receiving CAR T-cell therapy.
- This issue has been linked to potential cross-reactivity between the tests and the CAR-T therapy.
- A misleading positive result could postpone tissue transplant procedures or eliminate patients from qualification lists for essential medical products.
- Confirmatory testing is strongly recommended for positive HIV NAT results in these patients.
Tacrolimus Safety Alerts
Tacrolimus, an immunosuppressant used to avoid organ transplant rejection, has a narrow therapeutic range necessitating close monitoring. In Canada, it is available in three distinct oral formulations: immediate-release capsules, extended-release capsules, and prolonged-release tablets; these formulations are not interchangeable. Substituting these can cause dosing errors leading to significant patient risks.
| Brand Name | Strengths | Dosing Frequency | Market Authorization Holder (MAH) |
|---|---|---|---|
| Immediate-release capsules | |||
| Prograf | 0.5 mg, 1 mg, 5 mg | Twice daily | Astellas Pharma Canada Inc. |
| Sandoz Tacrolimus | 0.5 mg, 1 mg, 5 mg | Twice daily | Sandoz Canada Inc. |
| ACH-Tacrolimus | 0.5 mg, 1 mg, 5 mg | Twice daily | Accord Healthcare Inc |
| Extended-release capsules | |||
| Advagraf | 0.5 mg, 1 mg, 3 mg, 5 mg | Once daily | Astellas Pharma Canada Inc. |
| Prolonged-release tablets | |||
| Envarsus PA | 0.75 mg, 1 mg, 4 mg | Once daily | Endo Ventures Ltd Importer: Paladin Labs Inc. |
Health Canada previously cautioned healthcare providers about the risks associated with interchangeable use of different tacrolimus formulations due to ongoing reports of dispensing mix-ups. Factors such as similarities in product names and healthcare providers’ unfamiliarities contribute to these errors.
Recommended Strategies for Healthcare Professionals:
- Use complete brand names and descriptors to avoid confusion during medication management.
- Conduct a Best Possible Medication History (BPMH) when patients transition between care settings.
- Contact prescribers to clarify prescriptions that are ambiguous.
- Implement automated alerts within order entry systems to reinforce non-interchangeability of formulations.
- Encourage patients to notify healthcare providers of any changes regarding their medications.
Medical monitoring and supervision is essential if there is a consideration to change between tacrolimus formulations.
Report Health and Safety Issues
Health Canada urges users to report medication errors through the CMIRPS, which aims to enhance patient safety in collaboration with various health organizations.
Interesting Fact:
The Canadian Medication Incident Reporting and Prevention System (CMIRPS) systematically collects and assesses incident data to continually improve medication safety across healthcare settings.
Updates to Product Monographs
Recent updates to safety labelling for product monographs are provided for your information. You can find a complete list of updates on Health Canada’s Product monograph brand safety updates page, and access individual monographs through the Drug Product Database.
Zyvoxam (linezolid)
The sections concerning Warnings and Precautions, Adverse Reactions (Post-Market Adverse Reactions), and Patient Medication Information for the Canadian product monographs on linezolid in injectable and tablet forms have been updated to indicate the risk of rhabdomyolysis.
Key Notes for Healthcare Practitioners:
- Instances of rhabdomyolysis with notable creatine kinase (CK) increases have been recorded among linezolid users, occasionally leading to acute kidney issues.
- Regular CK level monitoring is advisable for patients at increased risk.
- Should rhabdomyolysis symptoms appear, it is critical to cease linezolid usage and commence appropriate treatment.
Scope
This monthly issue primarily targets healthcare professionals, providing insights into pharmaceuticals, biologics, medical devices, and natural health products. It summarizes key health product safety updates issued over the preceding month by Health Canada, alongside additional safety information designed to promote vigilance. The content presented herein does not encapsulate all findings but focuses on pertinent clinical insights requiring broader distribution.
Reporting Adverse Reactions
Canada Vigilance Program
Telephone: 1-866-234-2345
Fax or mail: Form available on MedEffect Canada
For detailed instructions on reporting an adverse reaction, visit the Adverse Reaction and Medical Device Problem Reporting page.
Helpful Links
Contact Us
We value your feedback. 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
- Footnote 1
- Ochodo, E.A., et al., Point-of-care tests detecting HIV nucleic acids for diagnosis of HIV-1 or HIV-2 infection in infants and children aged 18 months or less. Cochrane Database Syst Rev. 2021 Aug 12;8(8):CD013207.
- Footnote 2
- Canadian Blood Services. Accessed May 10, 2024. Available from: Backgrounder: Donor Testing – Human Immunodeficiency Virus (HIV) | Blood.ca. https://www.blood.ca/en/about-us/media/hiv/backgrounder-donor-testing-human-immunodeficiency-virus-hiv
- Footnote 3
- Villalba, J.A., et al., False-Positive Human Immunodeficiency Virus Test Results in Patients Receiving Lentivirus-Based Chimeric Antigen Receptor T-Cell Therapy: Case Report, Review of the Literature, and Proposed Recommendations. The Journal of Infectious Diseases, 2021. 225(11): p. 1933-1936.
- Footnote 4
- Alali, M., et al., Case Series of False-Positive HIV Test Results in Pediatric Acute Lymphoblastic Leukemia Patients Following Chimeric Antigen Receptor T-Cell Therapy: Guidance on How to Avoid and Resolve Diagnostic Dilemmas. Journal of the Pediatric Infectious Diseases Society, 2022. 11(8): p. 383-385.
- Footnote 5
- Ariza-Heredia, E.J., et al., False-positive HIV nucleic acid amplification testing during CAR T-cell therapy. Diagnostic Microbiology and Infectious Disease, 2017. 88(4): p. 305-307.
- Footnote 6
- Hauser, J.R., et al., False-Positive Results for Human Immunodeficiency Virus Type 1 Nucleic Acid Amplification Testing in Chimeric Antigen Receptor T Cell Therapy. J Clin Microbiol, 2019. 58(1).
- Footnote 7
- Hongeng, S., et al., Wild-type HIV infection after treatment with lentiviral gene therapy for β-thalassemia. Blood Advances, 2021. 5(13): p. 2701-2706.
- Footnote 8
- Zyvoxam (linezolid) [product monograph]. Kirkland (QC): Pfizer Canada ULC.; 2023.
Footnote
- Footnote *
- Immediate-release tacrolimus is also indicated for the treatment of active rheumatoid arthritis in adult patients for whom disease modifying anti-rheumatic drug (DMARD) therapy is ineffective or inappropriate. Tacrolimus is to be prescribed once daily for this purpose.