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

Teresa A Simon; John H Simon; Erin G Heaning; Andres Gomez-Caminero; Jahan P Marcu

doi:10.2147/DHPS.S391857

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

Drug Healthc Patient Saf. 2023 Jan 29:15:25-38. doi: 10.2147/DHPS.S391857. eCollection 2023.

Authors

Teresa A Simon¹, John H Simon¹, Erin G Heaning¹, Andres Gomez-Caminero¹, Jahan P Marcu^{1

2}

Affiliations

¹ Physicians Research Center, LLC, Toms River, NJ, USA.
² Marcu Enterprises, Jersey City, NJ, USA.

Abstract

Purpose: 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.

Methods: A case-series design was used.

Results: 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.

Conclusion: 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.

Keywords: adverse effects; adverse event; cannabinoid; cannabis; delta-8 tetrahydrocannabinol; hemp; hemp-derived; public health; safety.

Grants and funding

There was no funding source for this study.