Delta-8, a Cannabis-Derived Tetrahydrocannabinol Isomer: Evaluating Case Report Data in the Food and Drug Administration Adverse Event Reporting System (FAERS) Database

The aim of this study was to characterize the frequency of adverse effects where delta-8 tetrahydrocannabinol (D8-THC) was identified as a possible suspect drug in the FDA Adverse Event Reporting System (FAERS) database. A case-series design was used. A total of 183 cases listed D8-THC as a suspect...

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Bibliographic Details
Published in:Drug, healthcare and patient safety healthcare and patient safety, 2023-01, Vol.15, p.25-38
Main Authors: Simon, Teresa A, Simon, John H, Heaning, Erin G, Gomez-Caminero, Andres, Marcu, Jahan P
Format: Article
Language:English
Subjects:
adverse effects
adverse event
Cannabidiol
cannabinoid
cannabis
Case reports
Consumers
Controlled substances
delta-8 tetrahydrocannabinol
Drugs
Dyspnea
FDA approval
Health aspects
Health surveillance
Hemp
hemp-derived
Herbal medicine
Licenses
Marijuana
Medical personnel
Original Research
Pharmacovigilance
Public health
Respiratory diseases
safety
Side effects
Tetrahydrocannabinol
THC
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Summary:The aim of this study was to characterize the frequency of adverse effects where delta-8 tetrahydrocannabinol (D8-THC) was identified as a possible suspect drug in the FDA Adverse Event Reporting System (FAERS) database. A case-series design was used. A total of 183 cases listed D8-THC as a suspect drug in FAERS as of June 30, 2021. The most common events included dyspnea, respiratory disorder, and seizure. The reporting odds ratios were consistently and significantly greater than 2, a 2-fold increase from 2019 to 2021, indicating a potential safety signal. The first report of D8-THC, in the FAERS database, as a suspect drug appears to be in 2011. Overall, there are 183 total cases listing D8-THC as a suspect drug in the FAERS database as of June 30, 2021. Of the 183 cases, most were respiratory in nature.
ISSN:1179-1365
1179-1365
DOI:10.2147/DHPS.S391857