大麻合法化时代的药物警戒:利用社交媒体监测免疫抑制剂与大麻衍生产品之间的药物相互作用

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY
Matthew R. Allen, Gwenyth Portillo Wightman, Zechariah Zhu, Adam Poliak, Davey M. Smith, Mark Dredze, John W. Ayers
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引用次数: 0

摘要

导言:Epidiolex® 是美国 FDA 批准的唯一一种大麻衍生消费品 (CDP),其临床试验发现它与一种免疫抑制剂(他克莫司)发生了相互作用,导致药物毒性,这凸显了处方药与通常不受监管的消费品之间的独特交叉。方法我们在 Reddit 上搜索了与 CDP 或健康相关的子论坛,共搜索到 63,561,233 个帖子。我们从中找出了 190 个讨论免疫抑制剂和 CDP 的帖子。两名盲人调查员对以下内容进行了评估。(1) 消费者是否担心 CDP 与免疫抑制剂之间可能存在 DDI?(2) 是否有独特的不良事件归因于消费者 CDP 与免疫抑制剂之间的 DDI?结果在这些帖子中,有 66 个帖子(35%)表达了对潜在 DDI 的担忧,例如 "嘿,我的伴侣想试试我的药剂......她正在服用 Prograf [他克莫司],想和一个做过心脏移植手术的石头人谈谈"。四个帖子(2%)报告了独特的 DDI,如 "我有半传闻的临床结果,显示了我停止使用药物的协调作用......是 CBD。我的 PROGRAF 在 4 毫克时就达到了 30 毫克"。在报告的四种 DDIs 中,有两种与首次报告的 Epidiolex 相似。其余两个报告的 DDI 包括潜在的大麻二酚 (CBD)/ 西罗莫司或δ-9-四氢大麻酚 (THC)/ 西罗莫司相互作用和 THC/ 他克莫司相互作用,两者均导致药物毒性。这表明了在使用处方药的同时使用消费类 CDPs 所带来的风险,同时强调了需要加强监测,以监控消费类 CDPs 的药物安全信号,并制定考虑到消费市场独特性的全面法规。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Pharmacovigilance in the Age of Legalized Cannabis: Using Social Media to Monitor Drug–Drug Interactions Between Immunosuppressants and Cannabis-Derived Products

Introduction

A clinical trial of Epidiolex®, the only US FDA-approved cannabis-derived consumer product (CDP), discovered an interaction with an immunosuppressant (tacrolimus) that led to drug toxicity, highlighting the unique intersection of prescription and commonly unregulated consumer products.

Objective

We aimed to identify if similar drug–drug interactions (DDIs) are occurring among the consumer CDP market, even though they cannot be identified through trials.

Methods

We searched Reddit for subreddits related to CDPs or health, resulting in 63,561,233 posts. From these, we identified 190 posts discussing both immunosuppressants and CDPs. Two blinded investigators evaluated the following. (1) Was there a concern about a potential DDI between consumer CDPs and immunosuppressants? (2) Was there a unique adverse event attributed to a DDI between consumer CDPs and immunosuppressants?

Results

Of these, 66 posts (35%) expressed concern about a potential DDI, such as “Hey, my partner wants to try my edibles … she’s on Prograf [tacrolimus] and wants to talk to a stoner who’s had a heart transplant.” Four posts (2%) reported a unique DDI, such as “I have clinical results that are semi-anecdotal, showing the coordination to my halting substance use … It's the CBD. Shot my prograf to 30 at like 4 mg.” Two of the four reported DDIs are similar to those first reported for Epidiolex. The remaining two reported DDIs include a potential cannabidiol (CBD)/sirolimus or delta-9-tetrahydrocannabinol (THC)/sirolimus interaction and a THC/tacrolimus interaction, both resulting in drug toxicity.

Conclusion

This case study is the first to report on DDIs involving consumer CDPs, including both CBD and THC products, as well as a broader class of immunosuppressants. This demonstrates the risks associated with using consumer CDPs alongside prescription medications while highlighting the need for development of increased surveillance to monitor consumer CDPs for drug safety signals, as well as comprehensive regulations that take into account the unique characteristics of the consumer marketplace.

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来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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