Drug, Healthcare and Patient Safety (Jan 2023)
Delta-8, a Cannabis-Derived Tetrahydrocannabinol Isomer: Evaluating Case Report Data in the Food and Drug Administration Adverse Event Reporting System (FAERS) Database
Abstract
Teresa A Simon,1 John H Simon,1 Erin G Heaning,1 Andres Gomez-Caminero,1 Jahan P Marcu1,2 1Physicians Research Center, LLC, Toms River, NJ, USA; 2Marcu Enterprises, Jersey City, NJ, USACorrespondence: Teresa A Simon, Physicians Research Center, LLC, Toms River, NJ, 08753, USA, Tel +732 818-7900, Fax +732 557-0217, Email [email protected]: 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: cannabis, hemp-derived, safety, adverse effects, public health, cannabinoid, delta-8 tetrahydrocannabinol, hemp, adverse event
