Can Cannabis-Derived Data be Monitored in the FDA FAERS Database?



Recent reports on the consumption of delta-8 Tetrahydrocannabinol (THC) have led to a qualmish riddle. Delta-8 THC is an isomer of delta-9 THC, that some believe is legal to synthesize under the 2018 Hemp Farm bill. The U.S. Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) websites list delta-8 THC as schedule 1 drug.  Despite this conundrum and a lack of safety data, delta-8 THC products have exploded into the market. 

We explored the only known national adverse event reporting system: FDA Adverse Event Reporting System (FAERS), a US database originally designed to support the FDA's post marketing safety surveillance program for approved drugs and biologics. 

Repeated FAERS queries have been performed.  Product names (aka search terms): delta-8 THC; delta- 9 THC, cannabis sativa (CS), and cannabidiol (CBD) were searched.  

FAERS Data as of March 31, 2021, showed a total of 160 cases reporting delta-8 THC, 56 delta-9 THC cases, 591 CS and 7274 CBD reported as “suspect product active ingredient” 

Respiratory events were most common in the Delta-8 suspect cases compared to cannabidiol and cannabis sativa. Most cases occurred in 18 to 64 year-old males. 

Our results suggest a potentially different safety profile for delta-8 THC containing products. It is unclear if delta-8 THC or another factor, such as an adulterant or contaminant, is the cause of these events. Understanding the limitations of FAERs and our experience analyzing the AE data, we have designed a data collection tool for collecting more granular information on cannabis-derived products

Learning objectives:

1. Define the lack of and importance of collecting adverse events on cannabis-derived products.

2. Discuss cannabis-derived products that are available outside of the medical /regulated cannabis market that may not be that safe.

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