Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Clin Toxicol (Phila). 2023 Feb;61(2):123-130. doi: 10.1080/15563650.2022.2156881. Epub 2022 Dec 20.
There has been an increase in the interest and availability of products asserting to contain cannabidiol (CBD).
To describe demographic and clinical patterns in cases involving CBD exposures documented by the America's Poison Centers (AAPCC).
We extracted human exposure cases involving CBD from the U.S. National Poison Data System between July 2014 and June 2021. We described monthly case counts and data on demographics, exposure reason, clinical effects, medical outcomes, and co-exposures, overall and by U.S. Food and Drug Administration (FDA) approval status.
We identified 6,496 cases, of these, 85.2% involved exposures to non-FDA approved CBD. The monthly number of cases peaked at 336 in March 2021. Cases often occurred in children ages 2-12 years (36.2%). Although in this age group unintentional exposures represented most cases (94.1%), we identified therapeutic errors (3.9%), intentional use (3.0%), and adverse reactions (1.6%) in cases involving exposures to non-FDA approved CBD. Among the 5,248 (80.8%) cases involving exposure to a single product, we identified 44 major medical outcomes, all related to exposures to non-FDA approved CBD. The most frequent clinical effects included neurological, cardiac, and gastrointestinal effects. Among the 1,248 (19.2%) involving exposure to more than one product, the most frequent co-exposures included stimulants and street drugs, sedatives-hypnotics, antipsychotics, and analgesics.
This case series identified an increasing trend in CBD exposure cases managed by AAPCC. It showed serious medical outcomes in temporal association with exposure to non-FDA approved CBD products. Our findings also suggest both unintentional and intentional use of non-FDA approved CBD in children. Consumers should keep these products out of reach of children and exercise caution when purchasing and using non-FDA approved CBD products.
声称含有大麻二酚(CBD)的产品越来越受到关注和青睐。
描述美国毒物中心(AAPCC)记录的 CBD 暴露病例的人口统计学和临床模式。
我们从美国国家毒物数据系统中提取了 2014 年 7 月至 2021 年 6 月期间涉及 CBD 的人类暴露病例。我们描述了每月的病例数以及人口统计学数据、暴露原因、临床效果、医疗结果和共同暴露情况,总体情况和按美国食品和药物管理局(FDA)批准状态分别描述。
我们共发现 6496 例病例,其中 85.2%涉及非 FDA 批准的 CBD 暴露。每月病例数在 2021 年 3 月达到 336 例的峰值。病例常发生在 2-12 岁的儿童中(36.2%)。尽管在这个年龄组,非故意暴露占大多数病例(94.1%),但我们在非 FDA 批准的 CBD 暴露病例中发现了治疗错误(3.9%)、故意使用(3.0%)和不良反应(1.6%)。在 5248 例(80.8%)涉及单一产品暴露的病例中,我们确定了 44 种主要医疗结果,均与非 FDA 批准的 CBD 暴露有关。最常见的临床影响包括神经、心脏和胃肠道影响。在 1248 例(19.2%)涉及暴露于多种产品的病例中,最常见的共同暴露包括兴奋剂和街头毒品、镇静催眠药、抗精神病药和镇痛药。
本病例系列研究确定了 AAPCC 管理的 CBD 暴露病例呈上升趋势。它显示了与非 FDA 批准的 CBD 产品暴露有关的严重医疗结果。我们的研究结果还表明,儿童非故意和故意使用非 FDA 批准的 CBD。消费者应将这些产品放在儿童接触不到的地方,并在购买和使用非 FDA 批准的 CBD 产品时保持谨慎。