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



Presented By: Teresa A. Simon, MPH, MT

Speaker Biography: Ms. Simon has over 30 years of experience as a health professional and has published a number of peer reviewed articles. Reflecting her dedication to public health, her areas of focus have been evaluating the risks and benefits of new and established medications and determining their impact on quality of life. Teresa received her Master’s in Public Health Epidemiology from University of Medicine and Dentistry New Jersey and is an alumnus of the Jefferson University Cannabis Medicine graduate certificate course. She is also an adjunct fellow at the University of PA Center for Public Health Initiatives and the CEO/Owner of Physicians Research Center, LLC a clinical trial and consulting organization (www.prctrials.com www.budsinfo.com)…

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

Webinar Abstract: 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…

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