Post-Marketing Surveillance of Full-Spectrum Hemp Extract CBD Products for Reported Adverse Events a [Vi3RGEMhwUk]

Post-Marketing Surveillance of Full-Spectrum Hemp Extract CBD Products for Reported Adverse Events a [Vi3RGEMhwUk]

| 1h 28m 28s | Video has closed captioning.

Tags: Cannabis Research, Adverse Effects, CBD, Cannabis Adverse Events, CBD Side Effects, Medicine Kevin Spelman, PhD, MCPP, presents "Post-Marketing Surveillance of Full-Spectrum Hemp Extract CBD Products for Reported Adverse Events and Serious Adverse Events" at CannMed 23. 0:00 Intro 0:31 Disclosures 1:20 The Problem 2:08 The Solution 2:18 Methods Used 4:05 Phase I - Intake and Documentation of Original Incidents 5:06 Phase II - In Depth Review and Follow-up of Phase I Incidents 6:02 Phase III - Assessment of Strength of Association 7:23 Grades of Adverse Events 7:45 Dose Range 8:20 Results10:09 Summary of Adverse Events 11:30 Results continued 19:45 Previously Documented Adverse Events 20:21 Comparison of Adverse Events There is a paucity of data on the safety of hemp extracts in real-world use. While the number of clinical trials is building, the subject numbers are limited and conditions frequently do not mimic consumer use. Using a retrospective analysis of post-marketing surveillance data on full- spectrum hemp extract products (FSHE-Charlotte’s Web TM ) the frequency of adverse events (AEs) and serious adverse events (SAEs) of these products was assessed by analyzing AE reports and evaluating the total number of AEs against the total number of product units sold. From a total of approximately 1,939,172 product units sold during the 18-month period, 431 AEs were reported from 304 unique individuals, followed by a physician assessment. The incidence of AEs was 0.022% per unit sold. Seven AEs were classified as serious. The most common type of AEs reported were Grade 1 (CTCAE v5.0), and defined as asymptomatic or mild symptoms in the area of gastrointestinal (e.g. general abdominal discomfort) and nervous system disorders (e.g. dizziness/headache). Based on this dataset of spontaneous consumer reporting the FSHE products were determined to result in consumer reports of AEs (0.022%) and SAEs (0.00036%) and to be well tolerated at the recommended doses. These data, with the limitations of self- reports, are intended to be a starting point and we encourage more companies to explore post- marketing surveillance until more robust data are available. Learn More about CannMed: