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

IF 2.2 Q2 HEALTH CARE SCIENCES & SERVICES Drug, Healthcare and Patient Safety Pub Date : 2023-01-29 eCollection Date: 2023-01-01 DOI:10.2147/DHPS.S391857

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

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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.

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Delta-8，一种大麻衍生的四氢大麻酚异构体：评估食品药品管理局不良事件报告系统 (FAERS) 数据库中的病例报告数据。

目的：本研究旨在描述在美国食品药物管理局不良事件报告系统（FAERS）数据库中，δ-8四氢大麻酚（D8-THC）被确定为可能的可疑药物的不良反应频率：方法：采用病例序列设计：结果：截至2021年6月30日，共有183个病例在FAERS中将D8-THC列为可疑药物。最常见的事件包括呼吸困难、呼吸紊乱和癫痫发作。报告的几率比持续显著大于 2，从 2019 年到 2021 年增加了 2 倍，表明存在潜在的安全信号：结论：FAERS数据库中首次将D8-THC列为可疑药物的报告似乎是在2011年。截至 2021 年 6 月 30 日，FAERS 数据库中将 D8-THC 列为可疑药物的病例共有 183 例。在这 183 个案例中，大多数属于呼吸系统疾病。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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