Health Product InfoWatch: January 2025
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Health Products and Food Branch
Marketed Health Products Directorate
Health Product InfoWatch Editorial Team
ISSN: 2368-8025
Cat.: H167-1E-PDF
Pub.: 240000
Contents
- Monthly recap of health product safety information
- Betahistine and TEVA-Betahistine
- Chimeric Antigen Receptor T-cell (CAR-T) therapies - Breyanzi (lisocabtagene maraleucel), Carvykti (ciltacabtagene autoleucel), Kymriah (tisagenlecleucel), Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel)
- HMG-CoA reductase inhibitors - atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin and simvastatin
- PMS-Cinacalcet
- Unauthorized Health Products
- New health product safety information
- 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 December 2024 by Health Canada.
Betahistine and TEVA-Betahistine
Affected lots of Betahistine and TEVA-Betahistine tablets have been recalled as they exceeded or may have exceeded the interim acceptable intake limit for N-nitroso-betahistine.
Chimeric Antigen Receptor T-cell (CAR-T) therapies - Breyanzi (lisocabtagene maraleucel), Carvykti (ciltacabtagene autoleucel), Kymriah (tisagenlecleucel), Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel)
This safety review evaluated the risk of secondary T-cell malignancy associated with the use of CAR-T therapies. Health Canada's review found a possible link. Health Canada is working with the manufacturers to align the Canadian product monographs for all CAR-T therapies to include information about this risk.
HMG-CoA reductase inhibitors - atorvastatin, fluvastatin, lovastatin, pravastatin, rosuvastatin and simvastatin
This safety review evaluated the risk of myasthenia gravis, including ocular myasthenia, associated with the use of HMG-CoA reductase inhibitors. Health Canada's review found a possible link. Health Canada will work with the manufacturers to update the Canadian product monographs for all statin products that do not currently include this risk.
PMS-Cinacalcet
Affected lots of PMS-Cinacalcet have been recalled as they may have exceeded the established acceptable intake limit for N-nitroso-cinacalcet.
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 sexual enhancement products
- Advisory: Unauthorized skin lightening and skin treatment products
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 2023. These reports are suspected associations, which reflect the reporter's observations and opinions, and does 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.
2023 AR data
- 213,089 reports of ARs were received by the CVP from January 1 to December 31, 2023. These reports represent 75,515 domestic AR cases.Footnote *
- 74% of cases were classified as serious
- 24% required hospitalization
- 3% were life-threatening
- 9% reported a death
- 11 potential safety issues were identified from AR reports for health products during this period and 4 of these were considered safety signals.
- AR reports received in 2023 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
| Reporting source | Percentage |
|---|---|
| Market Authorization Holder | 86.9% |
| Hospital | 6.6% |
| Community | 6.2% |
Figure 2: Text description
| Product type | Percentage |
|---|---|
| Pharmaceuticals | 61% |
| Biologics | 42% |
| Natural health products | 1.2% |
| Radiopharmaceuticals | 0.8% |
| Other | 0.8% |
Distribution of AR cases by reporter type
- 22% from a physician
- 8% from a pharmacist
- 45% from other health professionals
- 25% from a consumer / other
Distribution of AR cases by sex
- 58% female
- 38% male
- 4% unknown
Figure 3: Text description
| Age group | Number of non serious cases | Number of serious cases |
|---|---|---|
| Unknown | 3,695 | 7,421 |
| Elderly (65 years and above) | 3,797 | 18,587 |
| Adult (19 – 64 years) | 11,415 | 27,653 |
| Adolescent (12 – 18 years) | 413 | 1,175 |
| Child (2-11 years) | 162 | 865 |
| Infant (less than 24 months) | 33 | 299 |
| Anatomical Therapeutic Chemical (ATC) group | % of times reported |
|---|---|
| Immunosuppressants | 45% |
| Antineoplastic agents | 17% |
| Psycholeptics | 5% |
| Analgesics | 3% |
| Drugs for obstructive airway diseases | 3% |
| System Organ Class | % of times reported |
|---|---|
| General disorders and administration site conditions | 57% |
| Injury, poisoning and procedural complications | 30% |
| Infections and infestations | 23% |
| Gastrointestinal disorders | 21% |
| Nervous system disorders | 17% |
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.
For more information, contact the Marketed Health Products Directorate.
2023 AEFI data
- 483 reports of AEFIs were received by the CVP from January 1 to December 31, 2023.Footnote †
- 76% of reports were classified as serious
- 13% required hospitalization
- 3% were life-threatening
- 3% reported a deathFootnote ‡
- No new safety signals were identified for vaccines during this period.Footnote §
Distribution of reports by reporter type
- 14% from a physician
- 19% from a pharmacist
- 20% from other health professionals
- 47% from a consumer / other
Distribution of reports by sex
- 63% female
- 28% male
- 9% unknown
Figure 1: Text description
| Age group | Number of non serious cases | Number of serious cases |
|---|---|---|
| Unknown | 6 | 161 |
| Elderly (65 years and above) | 41 | 94 |
| Adult (19 – 64 years) | 64 | 90 |
| Adolescent (12 – 18 years) | 1 | 6 |
| Child (2-11 years) | 4 | 6 |
| Infant (28 days to 23 months) | 2 | 8 |
The COVID data represents AEFI reports where the COVID vaccine was reported in association with another vaccine.
Figure 2: Text description
| Vaccine Groups | Number of non-serious reports | Number of serious reports | |
|---|---|---|---|
| Herpes Zoster | HZ | 66 | 252 |
| Influenza | INF | 22 | 87 |
| COVID-19 | COVID | 9 | 48 |
| Pneumococcal | PNEU | 13 | 19 |
| Meningococcal | MEN | 0 | 17 |
| Human papillomavirus | HPV | 0 | 10 |
| Hepatitis A and Hepatitis B | HAHB | 2 | 8 |
| Respiratory syncytial virus | RSV | 9 | 1 |
| Tetanus, diphtheria (reduced), acellular pertussis | Tdap | 3 | 4 |
| Tetanus | T | 3 | 2 |
Key findings:
- Herpes zoster vaccines: The 5 most frequently reported AEFIs were herpes zoster, vaccination failure, pain, pyrexia and pain in extremity. Most of the events of herpes zoster were co-reported with vaccination failure.
- Influenza vaccines: The 5 most frequently reported AEFIs were dyspnoea, pain, pneumonia, fatigue, and headache.
- For all vaccines: Other commonly reported terms included vomiting, erythema and pruritus.
Cannabis products adverse reaction data summary
Health Canada is responsible for monitoring the risks of cannabis products in Canada. Licence holders who sell or distribute cannabis products must report all serious adverse reactions (ARs) involving these products to Health Canada, as outlined in the Cannabis Adverse Reaction Reporting Guide. Consumers, patients, healthcare professionals, medical cannabis clinics and other individuals are also encouraged to voluntarily report any ARs involving cannabis.
For more information, please contact the Office of Cannabis Science and Surveillance.
2023 AR data
On January 10, 2025, Health Canada published a new report, which provides an overview of the cannabis-related ARs reported to Health Canada in 2023. This annual report is designed to help stakeholders better understand Health Canada's Vigilance Framework, which is used for cannabis products, and the AR data regarding cannabis.
As part of this release, the Key findings: Cannabis-related side effects data exploration tool was also updated. This tool presents data on key indicators of cannabis-related ARs collected by Health Canada from 2018 to 2023, allowing users to explore and interact with the data at an aggregate level.
Product monograph updates
The following safety labelling updates, which were recently made to the Canadian product monographs, have been included 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.
Contrave (naltrexone hydrochloride and bupropion hydrochloride), Wellbutrin (bupropion hydrochloride) and Zyban (bupropion hydrochloride)
The "Warnings and Precautions", "Adverse Reactions (Post-Market Adverse Reactions)", "Dosage and Administration", and "Patient Medication Information" sections of the Canadian product monographs for Contrave, Wellbutrin and Zyban have been updated with information on the risk of unmasking of Brugada syndrome.
Key messages for healthcare professionals:Footnote 1 Footnote 2 Footnote 3
- There have been isolated post-marketing reports of unmasking of Brugada syndrome with bupropion-containing products. Brugada syndrome is a disorder characterized by syncope, characteristic ECG changes, such as right bundle branch block and ST segment elevation in right precordial leads, and a risk of cardiac arrest and sudden death.
- It is advised to avoid use of bupropion-containing products in patients with Brugada syndrome. If any of these products are considered in patients with Brugada syndrome or in patients at risk of having Brugada syndrome (e.g., patients with unexplained syncope, patients with a family history of cardiac arrest or sudden death), an evaluation by a cardiologist should be sought prior to initiating treatment, to assess suitability of treatment and to determine the most appropriate strategy for monitoring cardiac effects.
- Patients should be informed about the signs and symptoms of Brugada syndrome.
- If unmasking of Brugada syndrome occurs, discontinue treatment with the bupropion-containing product.
Nolvadex-D (tamoxifen citrate)
The "Warnings and Precautions" and "Patient Medication Information" sections of the Canadian product monograph for Nolvadex-DFootnote ** have been updated with the risk of QTc interval prolongation in patients with underlying risks for QT prolongation and cardiac comorbidities.
Key messages for healthcare professionals:Footnote 4
- At the recommended dose, Nolvadex-D may prolong the QTc interval on the electrocardiogram (ECG) in patients with underlying risks for QT prolongation and cardiac comorbidities.
- ECG and electrolyte monitoring are recommended before and during treatment in such patients.
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
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
- MedEffectTM 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
- Footnote 1
-
Contrave (naltrexone hydrochloride and bupropion hydrochloride) [product monograph]. Laval (QC): Bausch Health, Canada Inc.; 2023.
- Footnote 2
-
Wellbutrin (bupropion hydrochloride) [product monograph]. Laval (QC): Bausch Health, Inc.; 2024.
- Footnote 3
-
Zyban (bupropion hydrochloride) [product monograph]. Laval (QC): Bausch Health, Canada Inc.; 2023.
- Footnote 4
-
Nolvadex-D (tamoxifen citrate) [product monograph]. Mississauga (ON): AstraZeneca Canada Inc., 2024.
Footnotes
- Footnote 1
-
A case consists of all information describing the AR(s) experienced by one patient at one time, which is suspected of being related to the use of one or more health products. A case may include an initial AR report and possibly several follow-up reports that provide additional information. Duplicate cases may exist if an AR report about the same event was received from different reporters.
- Footnote 2
-
These results exclude AEFI reports where a COVID-19 vaccine was the sole vaccine suspected. For information about adverse events that individuals have reported after receiving a COVID-19 vaccine as the sole suspected vaccine in Canada in 2023, please visit the Reported side effects following COVID-19 vaccination in Canada webpage at https://health-infobase.canada.ca/covid-19/vaccine-safety/
- Footnote 3
-
The information provided in these AEFI reports was not sufficiently detailed to assess the causal association between the reported event and the vaccine.
- Footnote 4
-
Serious events that were reported were either already listed in the product monographs of the respective vaccine or deemed unlikely to be related to the vaccination based on the presence of underlying medical conditions and/or concomitant medications, which could have contributed to the events.
- Footnote 5
-
At the time of publication, the Canadian product monograph update for Nolvadex-D has been completed. Updates for other tamoxifen citrate products will follow.
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