PMID- 37996777
OWN - NLM
STAT- MEDLINE
DCOM- 20240129
LR  - 20240206
IS  - 1179-1942 (Electronic)
IS  - 0114-5916 (Linking)
VI  - 47
IP  - 2
DP  - 2024 Feb
TI  - A Descriptive Analysis of Adverse Event Reports from the Quebec Cannabis 
      Registry.
PG  - 161-171
LID - 10.1007/s40264-023-01379-0 [doi]
AB  - 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((R)) 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.
CI  - (c) 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
FAU - Hachem, Yasmina
AU  - Hachem Y
AD  - Medical Cannabis Program in Oncology, McGill University Health Center, Montreal, 
      QC, Canada.
AD  - Department of Medicine, Mount Auburn Hospital, Harvard Medical School, Cambridge, 
      MA, USA.
FAU - Moride, Yola
AU  - Moride Y
AUID- ORCID: 0000-0002-8753-2274
AD  - Center for PharmacoEpidemiology and Treatment Science, Rutgers, The State 
      University of New Jersey, New Brunswick, NJ, USA. morideyo@ifh.rutgers.edu.
AD  - YolaRX Consultants, Montreal, QC, Canada. morideyo@ifh.rutgers.edu.
FAU - Castilloux, Anne-Marie
AU  - Castilloux AM
AD  - YolaRX Consultants, Montreal, QC, Canada.
FAU - Castillon, Genaro
AU  - Castillon G
AD  - YolaRX Consultants, Montreal, QC, Canada.
FAU - Kalaba, Maja
AU  - Kalaba M
AD  - Canopy Growth Corporation, Smiths Falls, ON, Canada.
FAU - Neron, Andree
AU  - Neron A
AD  - Bureau d'evaluation medicale (Consultant on request in medical cannabis-related 
      pharmacological assessments and needs for injured workers), Quebec City, QC, 
      Canada.
FAU - Gamaoun, Rihab
AU  - Gamaoun R
AD  - Research Institute of the McGill University Health Centre, Montreal, QC, Canada.
FAU - Martel, Marc O
AU  - Martel MO
AD  - Department of Anesthesiology, Faculty of Dental Medicine and Oral Health 
      Sciences, McGill University, Montreal, QC, Canada.
FAU - Beaulieu, Pierre
AU  - Beaulieu P
AD  - Departement de pharmacologie et physiologie/Departement d'anesthesiologie et de 
      medecine de la douleur, Faculte de medecine de l'Universite de Montreal, 
      Montreal, QC, Canada.
FAU - Ware, Mark
AU  - Ware M
AD  - Alan Edwards Pain Management Unit, McGill University Health Center, Montreal, QC, 
      Canada.
FAU - Vigano, Antonio
AU  - Vigano A
AD  - Medical Cannabis Program in Oncology, McGill University Health Center, Montreal, 
      QC, Canada.
AD  - Division of Palliative and Supportive Care, McGill University Health Center, 
      Montreal, QC, Canada.
LA  - eng
PT  - Journal Article
DEP - 20231123
PL  - New Zealand
TA  - Drug Saf
JT  - Drug safety
JID - 9002928
SB  - IM
MH  - Adult
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - Male
MH  - *Cannabis/adverse effects
MH  - Dizziness/chemically induced/epidemiology
MH  - Quebec
MH  - Sleepiness
MH  - Vomiting
MH  - Headache/chemically induced/epidemiology
MH  - Nausea
MH  - Registries
EDAT- 2023/11/24 00:42
MHDA- 2024/01/29 06:43
CRDT- 2023/11/23 23:48
PHST- 2023/10/30 00:00 [accepted]
PHST- 2024/01/29 06:43 [medline]
PHST- 2023/11/24 00:42 [pubmed]
PHST- 2023/11/23 23:48 [entrez]
AID - 10.1007/s40264-023-01379-0 [pii]
AID - 10.1007/s40264-023-01379-0 [doi]
PST - ppublish
SO  - Drug Saf. 2024 Feb;47(2):161-171. doi: 10.1007/s40264-023-01379-0. Epub 2023 Nov 
      23.