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A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry

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Abstract

Introduction

Published data on the safety of natural medical cannabis (MC) when used in the real-world clinical practice setting are lacking. This study aimed to describe adverse events (AEs) reported across three years following MC initiation.

Methods

The Quebec Cannabis Registry (QCR) was a prospective registry of adults enrolled through participating physicians when they initiated MC between May 2015 and October 2018. Follow-up ended at MC discontinuation, loss to follow-up, three years, or end of data collection (May 2019). Data were collected at baseline and at follow-up visits every three months for the first two years, then once in the third year. Physicians filled adverse event (AE) reports, which were coded using MedDRA® preferred terms (PTs), and descriptive analyses were conducted.

Results

A total of 2991 patients were enrolled (mean age 50.9 years, 50.2% females). During follow-up, 108 patients (3.6%) experienced moderate or severe AEs, yielding 111 AE reports (three patients had two reports) and 214 AEs (average 1.9 AEs per report). Mild AEs were recorded as a reason for MC discontinuation for nine patients, but no AE reports were available. The most common PTs for ingested MC (62 reports) were dizziness (12.9%), nausea (11.3%), somnolence (9.7%), and vomiting (8.1%), and for inhaled MC (23 reports), headache (13.0%) was the most common. The most frequent PTs associated with tetrahydrocannabinol (THC)-dominant MC (25 reports) were dizziness and somnolence (12.0% each); for cannabidiol (CBD)-dominant MC (20 reports), vomiting (20.0%) was most common; and dizziness (17.2%), nausea (13.8%), somnolence (10.3%), and headache (8.6%) were the most frequent for balanced MC (58 reports).

Conclusion

No new safety concerns were identified relative to the published literature, although notable differences in AE profile between modes of administration and cannabinoid content ratios should be considered by health professionals. Further work identifying and managing risk factors for AEs is warranted to maintain a favorable benefit-risk balance for MC.

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Author information

Authors and Affiliations

  1. Medical Cannabis Program in Oncology, McGill University Health Center, Montréal, QC, Canada

    Yasmina Hachem & Antonio Vigano

  2. Department of Medicine, Mount Auburn Hospital, Harvard Medical School, Cambridge, MA, USA

    Yasmina Hachem

  3. Center for PharmacoEpidemiology and Treatment Science, Rutgers, The State University of New Jersey, New Brunswick, NJ, USA

    Yola Moride

  4. YolaRX Consultants, Montréal, QC, Canada

    Yola Moride, Anne-Marie Castilloux & Genaro Castillon

  5. Canopy Growth Corporation, Smiths Falls, ON, Canada

    Maja Kalaba

  6. Bureau d’évaluation médicale (Consultant on request in medical cannabis-related pharmacological assessments and needs for injured workers), Québec City, QC, Canada

    Andrée Néron

  7. Research Institute of the McGill University Health Centre, Montréal, QC, Canada

    Rihab Gamaoun

  8. Department of Anesthesiology, Faculty of Dental Medicine and Oral Health Sciences, McGill University, Montréal, QC, Canada

    Marc O. Martel

  9. Département de pharmacologie et physiologie/Département d’anesthésiologie et de médecine de la douleur, Faculté de médecine de l’Université de Montréal, Montréal, QC, Canada

    Pierre Beaulieu

  10. Alan Edwards Pain Management Unit, McGill University Health Center, Montréal, QC, Canada

    Mark Ware

  11. Division of Palliative and Supportive Care, McGill University Health Center, Montréal, QC, Canada

    Antonio Vigano

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  1. Yasmina Hachem
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Corresponding author

Correspondence to Yola Moride.

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Funding

This research was supported by grants from the Canadian Consortium for the Investigation of Cannabinoids, the Collège des Médecins du Québec (CMQ) and unrestricted grants from several licensed cannabis producers (Bedrocan, Mettrum and Tweed; these three companies merged during the study conduct into one company called Canopy Growth Corporation) and nowadays Spectrum Therapeutics is the medical division of Canopy Growth Corporation). Funding for data analysis was received from the Alan Edwards Pain Management Unit of the McGill University Health Centre. Cedars Cancer Foundation and Rossy Cancer Network supported the Medical Cannabis Program in Oncology of the McGill University Health Center, which provided most data on oncology patients to the Quebec Cannabis Registry (QCR). No funding agency had input into the design and conduct of the QCR, although the CMQ was present at development meetings.

Competing interests

YM, AMC, and GC are employees of YolaRX Consultants, which provides consulting services to the pharmaceutical industry and cannabis manufacturers on topics unrelated to this research. MW and MK were  employees of Canopy Growth Corporation (MW: 2018–2022 and MK: 2019–2023). AN is a consultant on request in medical cannabis-related pharmacological assessments and needs for injured workers (Bureau d'évaluation médicale). AV was a member of the Clinical Advisory Board for Tilray, Canopy Growth Corporation, Syqe and EmpowerPharm. Until March 2020, AV was the Research Director of Santé Cannabis, Montreal, Canada. MM, PB, RG, and YH have no competing interest.

Availability of data and material

No additional data available.

Code availability

There is no code available.

Authors contributions

AV, PB, and MW, contributed to the registry design. YM designed the safety analysis and AMC did the data analysis. All authors contributed to the manuscript preparation. All authors read and approved the final manuscript.

Ethics approval

The project was initially approved by the central research ethics committee of the Ministry of Health and Social Services (CCER) of Quebec, which monitored the project for the private clinics and the participating institutions of the health and social services network. On 03 May 2019, the McGill University Health Centre Research Ethics Board took over the role of the CCER for the QCR.

Consent to participate

All participants provided informed consent to participate in the registry. Information is anonymous and only aggregate data are reported.

Consent for publication

Not applicable.

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Hachem, Y., Moride, Y., Castilloux, AM. et al. A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis Registry. Drug Saf 47, 161–171 (2024). https://doi.org/10.1007/s40264-023-01379-0

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