Brown Joshua D, Winterstein Almut G
Center for Drug Evaluation & Safety, Department of Pharmaceutical Outcomes & Policy, University of Florida College of Pharmacy, Gainesville, FL 32610, USA.
Department of Epidemiology, College of Public Health and Health Professions, University of Florida, Gainesville, FL 32610, USA.
J Clin Med. 2019 Jul 8;8(7):989. doi: 10.3390/jcm8070989.
Cannabidiol (CBD) is ubiquitous in state-based medical cannabis programs and consumer products for complementary health or recreational use. CBD has intrinsic pharmacologic effects and associated adverse drug events (ADEs) along with the potential for pharmacokinetic and pharmacodynamic drug-drug interactions (DDIs). Given CBD use among patients with complex conditions and treatment regimens, as well as its expanded consumer use, awareness of potential safety issues with CBD is needed. Prescribing information for federally approved products containing CBD were reviewed. Data on ADEs and DDIs were extracted and summarized. Nearly one-half of CBD users experienced ADEs, which displayed a general dose-response relationship. Common ADEs include transaminase elevations, sedation, sleep disturbances, infection, and anemia. Given CBD effects on common biological targets implicated in drug metabolism (e.g., CYP3A4/2C19) and excretion (e.g., P-glycoprotein), the potential for DDIs with commonly used medication is high. General clinical recommendations of reducing substrate doses, monitoring for ADEs, and finding alternative therapy should be considered, especially in medically complex patients. CBD is implicated as both a victim and perpetrator of DDIs and has its own ADE profile. These effects should be considered in the risk-benefit assessment of CBD therapy and patients and consumers made aware of potential safety issues with CBD use.
大麻二酚(CBD)在基于州的医用大麻项目以及用于辅助健康或娱乐用途的消费品中普遍存在。CBD具有内在药理作用和相关的药物不良事件(ADEs),同时存在药代动力学和药效学药物相互作用(DDIs)的可能性。鉴于患有复杂病症和治疗方案的患者使用CBD,以及其在消费者中的使用范围不断扩大,需要了解CBD潜在的安全问题。对含有CBD的联邦批准产品的处方信息进行了审查。提取并总结了关于ADEs和DDIs的数据。近一半的CBD使用者经历了ADEs,呈现出一般的剂量反应关系。常见的ADEs包括转氨酶升高、镇静、睡眠障碍、感染和贫血。鉴于CBD对参与药物代谢(如CYP3A4/2C19)和排泄(如P-糖蛋白)的常见生物学靶点有影响,与常用药物发生DDIs的可能性很高。应考虑减少底物剂量、监测ADEs以及寻找替代疗法等一般临床建议,尤其是在病情复杂的患者中。CBD既是DDIs的受害者也是肇事者,并有其自身的ADEs特征。在CBD治疗的风险效益评估中应考虑这些影响,并让患者和消费者了解使用CBD的潜在安全问题。