Health Product InfoWatch, March 2020
Health Products and Food Branch
Marketed Health Products Directorate
Health Product InfoWatch Editorial Team
- Health products mentioned in this issue
- Monthly recap
- New information
- Helpful links
Health products mentioned in this issue
Pharmaceuticals and biologics
Natural health products
Coronavirus disease (COVID-19): updates
For updates on the Coronavirus disease (COVID-19), visit Canada.ca/coronavirus. This webpage includes a dedicated section for healthcare professionals.
Health Canada has announced a number of COVID-19 related notices relevant to drugs and medical devices:
- Optimizing the use of masks and respirators during the COVID-19 outbreak [2020-03-24]
- List of diagnostic devices for use against coronavirus (COVID-19) [2020-03-23]
- Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors [2020-03-23]
- Notice for Industry: Mandatory Reporting Requirement during the COVID-19 Pandemic [2020-03-23]
- Notice for Hospitals: Mandatory Reporting Requirement during the COVID-19 Pandemic [2020-03-23]
- Notice: Expedited Review of Health Product Submissions and Applications to address COVID-19 [2020-03-18]
Health Canada's new Medical Device Directorate
The Health Products and Food Branch has created a new, stand-alone Medical Devices Directorate. The new Directorate will take a life cycle approach to regulating medical devices for human use.
For more information, please visit the new Medical Devices Directorate Web page.
Monthly recap of health product safety information
The following is a list of health product advisories, type I recalls as well as summaries of completed safety reviews published in February 2020 by Health Canada.
This safety review evaluated the risk of dysglycemia associated with direct-acting antivirals (DAAs). Health Canada's review concluded that there is a link between DAAs and dysglycemia, with evidence supporting the link between DAAs and hypoglycemia in diabetic patients. Health Canada is working with the manufacturers to update the Canadian product monographs for DAAs to inform about this risk.
Summary Safety Review – Direct-acting antivirals
Apotex Inc., Ranbaxy Pharmaceuticals Canada Inc. and JAMP Pharma Corporation have recalled certain lots of APO-Metformin ER, RAN-Metformin and Jamp-Metformin respectively. The affected lots contain or may contain N-nitrosodimethylamine (NDMA) above the acceptable limit. The Affected products table in the Information Update provides information on the recalled lots.
- Information Update – Metformin
- Drug recall – APO-Metformin
- Drug recall – Jamp-Metformin
- Drug recall – RAN-Metformin
Performance Plus capsules
Health Canada has suspended the product licence for Performance Plus capsules (NPN 80053999) because it may pose serious health risks, such as heart attack and stroke. Performance Plus is distributed by TW Trade and promoted as a natural health product for sexual enhancement. Health Canada laboratory testing found that it contains sildenafil, which is not listed on the product label.
Advisory – Performance Plus capsules
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 – Multiple unauthorized health products
- Advisory – Unauthorized skin lightening health products
New health product safety information
The following topics have been selected to raise awareness and, in some cases, to stimulate reporting of similar adverse reactions.
Product monograph updates
The following safety labelling updates, which were recently made to the Canadian product monograph, have been selected for your awareness. A complete list of safety labelling updates for pharmaceuticals is available on Health Canada's Product monograph brand safety updates page. Canadian product monographs can be accessed through Health Canada's Drug Product Database.
The risks of hepatitis B virus (HBV) reactivation and progressive multifocal leukoencephalopathy (PML) have been included in the Warnings and Precautions, Adverse Reactions (Post-Market Adverse Drug Reactions) and Patient Medication Information sections of the Canadian product monograph for Kyprolis.
Key messages for healthcare professionals:Kyprolis Footnote 1
- Cases of HBV reactivation have been reported in patients receiving Kyprolis.
- Patients should be tested for HBV infection before initiating treatment. For patients who are carriers of HBV, prophylaxis with antivirals should be considered before, throughout, and for at least 6 months after the end of the treatment.
- Carriers of HBV who require treatment with Kyprolis should be closely monitored for signs and symptoms of active HBV infection (jaundice, abdominal pain, joint pain, weakness and fatigue, nausea and vomiting) throughout and following the end of treatment. Consider consulting a specialist for patients who test positive for HBV infection prior to or during treatment.
- The safety of resuming Kyprolis after HBV reactivation is adequately controlled, is not known. Therefore, prescribers should weigh the risks and benefits when considering resumption of therapy in this situation.
- Cases of PML (blurred or double vision, blindness, aphasia, muscle weakness, coordination and gait difficulties, persistent numbness, sensory deficit, cognitive dysfunction) have been reported in patients treated with Kyprolis who have had prior or concurrent immunosuppressive therapy.
- Patients should be monitored for any new or worsening neurologic, cognitive or behavioural signs or symptoms that may be suggestive of PML as part of the differential diagnosis of central nervous system disorders. If PML is suspected, patients should be promptly referred to a specialist and appropriate diagnostic testing should be initiated. Kyprolis should be discontinued if PML diagnosis is confirmed.
- Kyprolis Footnote 1
Kyprolis (carfilzomib) [product monograph]. Mississauga (ON): Amgen Canada Inc.; 2020.
Notice of market authorization with conditions
A Notice of Compliance with Conditions (NOC/c) is a form of market authorization with conditions granted to a product on the basis of promising evidence of clinical effectiveness following review of the submission by Health Canada. Communicating a NOC/c is intended to raise awareness on the details of the drug and the nature of authorization granted.
Healthcare professionals are encouraged to report to Health Canada any adverse reactions suspected of being associated with marketed health products, including drugs authorized under the NOC/c policy.
The content of these notices reflects current information at the time of publication. Conditions associated with the NOC/c will remain until they have been fulfilled and authorized by Health Canada, in accordance with the NOC/c Policy. For the most up-to-date information, consult Health Canada's NOC database.
Rozlytrek (entrectinib): Authorization with conditions
Health Canada has issued a Notice of Compliance, under the Notice of Compliance with Conditions policy for Rozlytrek (entrectinib), capsules, 100 mg and 200 mg. Rozlytrek is indicated for the treatment of adult patients with unresectable locally advanced or metastatic extracranial solid tumours, including brain metastases, that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, and with no satisfactory treatment options. Patients should be advised about the conditional market authorization for this indication.
For the complete prescribing information and information available for the patients/caregivers, please consult the Rozlytrek Canadian product monograph. The product monograph can be accessed through Health Canada's Drug Product Database, the Hoffmann-La Roche Limited Web site or by contacting Hoffmann-La Roche Limited at 1-888-762-4388. Contact the company for a copy of any references, attachments or enclosures.
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
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.
- MedEffect™ Canada
- Recalls and Safety Alerts Database
- New Safety and Effectiveness Reviews
- Canada Vigilance Adverse Reaction Online Database
- Drug Product Database
- Medical Devices Active Licence Listing
- Licensed Natural Health Products Database
- The Drug and Health Product Register
- Drug Shortages Canada
- Annual trends for adverse reaction case reports and medical device problem incidents
- Stop Illegal Marketing of Drugs and Devices
Your comments are important to us. Let us know what you think by reaching us at HC.infowatch-infovigilance.SC@canada.ca
Marketed Health Products Directorate
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© 2020 Her Majesty the Queen in Right of Canada. This publication may be reproduced without permission provided the source is fully acknowledged. The use of this publication for advertising purposes is prohibited. Health Canada does not assume liability for the accuracy or authenticity of the information submitted in case reports.
Adverse reactions (ARs) to health products are considered to be suspicions, as a definite causal association often cannot be determined. Spontaneous reports of ARs cannot be used to estimate the incidence of ARs because ARs remain underreported and patient exposure is unknown.
Due to time constraints relating to the production of this publication, information published may not reflect the most current information.
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