Postmarketing Surveillance of Full Spectrum Hemp Extract CBD Products: Reported Adverse Events and Serious Adverse Events.

IF 1.9 Q3 PHARMACOLOGY & PHARMACY
Colleen M Kingsbury, Ivori Zvorsky, Kevin Spelman
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引用次数: 0

Abstract

Background: There 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.

Methods: A 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.

Results: During 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).

Conclusions: Approximately 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.

全谱大麻提取物 CBD 产品上市后监测:报告的不良事件和严重不良事件。
背景:人们对以大麻提取物为特色的产品越来越感兴趣,并要求获得更多有关其安全性的数据。迄今为止,有关这些产品安全性的公开数据还很少:对在美国收集到的夏洛特之网公司(Charlotte's Web,CW)生产的全谱大麻提取物(FSHE)产品的上市后监测数据进行了为期 18 个月(2019 年 1 月至 2020 年 7 月)的回顾性分析。通过分析不良事件(AE)报告与购买产品的估计消费者人数和售出产品总数的对比,评估了不良事件(AE)和严重不良事件(SAE)的发生频率:在 18 个月期间,约 646,391 名消费者购买了 1,939,172 件产品,304 人报告了 431 例 AE。估计报告至少一次不良事件的消费者比例为 0.05%。每售出一件产品发生不良事件的比例为 0.02%。根据《不良事件通用术语标准》的分类,报告的大多数不良事件(98.14%)为 1 级(即无症状或引起轻微症状)。有 7 例 AE 被归类为严重 AE,每售出一种产品发生 SAE 的比例为 0.0004%。所报告的 SAE 均未被列为 4 级或 5 级(即危及生命或致命):在 2019 年 1 月至 2020 年 7 月期间购买 CW FSHE 产品的消费者中,约有 0.05% 报告了不良事件。每个售出产品的 AE 和 SAE 百分比分别为 0.02% 和 0.0004%。这些数据表明,在推荐剂量下,CW FSHE 产品似乎具有良好的耐受性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Drugs - Real World Outcomes
Drugs - Real World Outcomes PHARMACOLOGY & PHARMACY-
CiteScore
3.60
自引率
5.00%
发文量
49
审稿时长
8 weeks
期刊介绍: Drugs - Real World Outcomes targets original research and definitive reviews regarding the use of real-world data to evaluate health outcomes and inform healthcare decision-making on drugs, devices and other interventions in clinical practice. The journal includes, but is not limited to, the following research areas: Using registries/databases/health records and other non-selected observational datasets to investigate: drug use and treatment outcomes prescription patterns drug safety signals adherence to treatment guidelines benefit : risk profiles comparative effectiveness economic analyses including cost-of-illness Data-driven research methodologies, including the capture, curation, search, sharing, analysis and interpretation of ‘big data’ Techniques and approaches to optimise real-world modelling.
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