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,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...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2023-01-01
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| Series: | Drug, Healthcare and Patient Safety |
| Subjects: | |
| Online Access: | https://www.dovepress.com/delta-8-a-cannabis-derived-tetrahydrocannabinol-isomer-evaluating-case-peer-reviewed-fulltext-article-DHPS |
| _version_ | 1811168799979732992 |
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| author | Simon TA Simon JH Heaning EG Gomez-Caminero A Marcu JP |
| author_facet | Simon TA Simon JH Heaning EG Gomez-Caminero A Marcu JP |
| author_sort | Simon TA |
| collection | DOAJ |
| description | 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 prctrials@gmail.comPurpose: 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 |
| first_indexed | 2024-04-10T16:32:40Z |
| format | Article |
| id | doaj.art-a93d726700814fed802acf9aa005dc90 |
| institution | Directory Open Access Journal |
| issn | 1179-1365 |
| language | English |
| last_indexed | 2024-04-10T16:32:40Z |
| publishDate | 2023-01-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Drug, Healthcare and Patient Safety |
| spelling | doaj.art-a93d726700814fed802acf9aa005dc902023-02-08T22:17:22ZengDove Medical PressDrug, Healthcare and Patient Safety1179-13652023-01-01Volume 15253881334Delta-8, a Cannabis-Derived Tetrahydrocannabinol Isomer: Evaluating Case Report Data in the Food and Drug Administration Adverse Event Reporting System (FAERS) DatabaseSimon TASimon JHHeaning EGGomez-Caminero AMarcu JPTeresa 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 prctrials@gmail.comPurpose: 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 eventhttps://www.dovepress.com/delta-8-a-cannabis-derived-tetrahydrocannabinol-isomer-evaluating-case-peer-reviewed-fulltext-article-DHPScannabishemp-derivedsafetyadverse effectspublic healthcannabinoiddelta-8 tetrahydrocannabinolhempadverse event |
| spellingShingle | Simon TA Simon JH Heaning EG Gomez-Caminero A Marcu JP Delta-8, a Cannabis-Derived Tetrahydrocannabinol Isomer: Evaluating Case Report Data in the Food and Drug Administration Adverse Event Reporting System (FAERS) Database Drug, Healthcare and Patient Safety cannabis hemp-derived safety adverse effects public health cannabinoid delta-8 tetrahydrocannabinol hemp adverse event |
| title | Delta-8, a Cannabis-Derived Tetrahydrocannabinol Isomer: Evaluating Case Report Data in the Food and Drug Administration Adverse Event Reporting System (FAERS) Database |
| title_full | Delta-8, a Cannabis-Derived Tetrahydrocannabinol Isomer: Evaluating Case Report Data in the Food and Drug Administration Adverse Event Reporting System (FAERS) Database |
| title_fullStr | Delta-8, a Cannabis-Derived Tetrahydrocannabinol Isomer: Evaluating Case Report Data in the Food and Drug Administration Adverse Event Reporting System (FAERS) Database |
| title_full_unstemmed | Delta-8, a Cannabis-Derived Tetrahydrocannabinol Isomer: Evaluating Case Report Data in the Food and Drug Administration Adverse Event Reporting System (FAERS) Database |
| title_short | Delta-8, a Cannabis-Derived Tetrahydrocannabinol Isomer: Evaluating Case Report Data in the Food and Drug Administration Adverse Event Reporting System (FAERS) Database |
| title_sort | delta 8 a cannabis derived tetrahydrocannabinol isomer evaluating case report data in the food and drug administration adverse event reporting system faers database |
| topic | cannabis hemp-derived safety adverse effects public health cannabinoid delta-8 tetrahydrocannabinol hemp adverse event |
| url | https://www.dovepress.com/delta-8-a-cannabis-derived-tetrahydrocannabinol-isomer-evaluating-case-peer-reviewed-fulltext-article-DHPS |
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