ArticleDrugs - real world outcomes2024
Postmarketing Surveillance of Full Spectrum Hemp Extract CBD Products: Reported Adverse Events and Serious Adverse Events.
Article in Drugs - real world outcomes, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
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Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThere is a growing interest in products featuring hemp extracts and a demand for more data regarding their safety. To date, there is a paucity of published data on the safety of these products.
methodsA retrospective analysis of postmarketing surveillance data collected in the United States on full spectrum hemp extract (FSHE) products manufactured by Charlotte's Web (CW) was conducted over an 18-month period (January 2019 to July 2020). The frequency of adverse events (AEs) and serious adverse events (SAEs) was assessed by analyzing AE reports against the estimated number of consumers who purchased products and the total number of products sold.
resultsDuring the 18-month period, approximately 646,391 consumers purchased 1,939,172 products and 431 AEs were reported by 304 individuals. The estimated percentage of consumers who reported at least one adverse event was 0.05%. The percentage of AEs per products sold was 0.02%. Most AEs (98.14%) reported were Grade 1 (i.e., asymptomatic or causing mild symptoms), as classified by the Common Terminology Criteria for Adverse Events. Seven AEs were classified as serious, and the percentage of SAEs per products sold was 0.0004%. None of the reported SAEs were classified as a Grade 4 or Grade 5 (i.e., life threatening or fatal).
conclusionsApproximately 0.05% of consumers who purchased the CW FSHE products from January 2019 to July 2020 reported an adverse event. The percentage of AEs and SAEs per products sold was 0.02% and 0.0004%, respectively. These data demonstrate that CW FSHE products appear to be well tolerated at recommended doses.
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Registered trials
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