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A Feasibility Assessment of the FDA Adverse Event Reporting System for the Detection of Cannabis-Related Safety Signals
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A Feasibility Assessment of the FDA Adverse Event Reporting System for the Detection of Cannabis-Related Safety Signals
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Journal Article
A Feasibility Assessment of the FDA Adverse Event Reporting System for the Detection of Cannabis-Related Safety Signals
2024
Overview
Aim/Objective: To assess the feasibility of using FAERS for cannabis safety surveillance by characterizing cannabis reporting and exploring trends over time. Methods: ADR reports were queried from 1999 through 2023. We explored self-reported terminology used to describe cannabis products and classified them into pharmacologically and pharmacovigilancerelevant groups [5, 6]. Additionally, we characterized the distribution of reporter demographic characteristics and the MedDRA [7] terminologies at the preferred term level in reports with cannabis. Results: A total of 1204 unique terms were used to report cannabisrelated products, of which 660 (54.8%) represented the major cannabinoids found in medical and recreational products. A total of 42654 reports were identified mentioning cannabis-derived products, with 14412 (33.8%) reported as primary suspect drugs and 9806 (23.0%) reported as secondary suspect drugs. We noted reporting trends reflective of the availability of marketed cannabis-derived drugs by country and the legalization status over time. We also summarized the extent to which other reporting characteristics contributed to feasibility. Conclusion: The cannabis post-marketing surveillance process poses unique challenges to meet the distinct characteristics of these products. In our descriptive analysis of cannabis reporting in FAERS, we found mixed results on the potential feasibility of using this spontaneous reporting system for a similar purpose as with pharmaceutical safety signal detection. This project highlights the uniqueness of cannabis-related adverse events, implying that, ultimately, additional aspects may also be considered when collecting, coding, and assessing self-reports of ADR regarding cannabis use
Publisher
Springer Nature B.V
Subject
