Analysis of the Safety Profile of Cannabis-Derived Products Using the FDA Adverse Event Reporting System Databases

Abstract

In many parts of the United States (U.S.) and other countries, including Canada, evolving changes in the legalization and regulation of cannabis use have led to expanding access to a wide variety of cannabis-derived products (CDPs). CDPs, which can range from highly regulated pharmaceutical formulations to less controlled or illicit products, have become increasingly popular among diverse populations for both medical and recreational purposes. As CDP consumption increases, particularly across a heterogeneous population with varying demographics, health conditions, and usage patterns, the potential for unknown or unexpected adverse drug reactions (ADRs) also increases. This heterogeneity in both CDPs and population creates a complex landscape where the safety profile of these products may differ from those observed in pre-marketing safety assessments of standardized CDPs. The use of spontaneous reporting systems (SRSs) such as the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) is a valuable tool for the rapid detection of unexpected emerging safety signals using real-world data. We conducted a descriptive analysis and a disproportionality analysis of CDP-related spontaneous adverse event reports (AERs) queried from FAERS from the first quarter of 1999 to the first quarter of 2023. While we identified unique challenges in the post- marketing surveillance process for CDPs, with heterogeneous reporting patterns and trends across all products, we also demonstrated that FAERS data followed expected temporal and regulatory trends and can thus be applied for signal detection research. We then demonstrated that CDPs containing similar active ingredients may produce different signal detection safety profiles. Therefore, this work provided insights into the design of future cannabis safety assessment studies.