Labeling Accuracy of Cannabidiol Extracts Sold Online

Bonn‐Miller, Marcel O.; Loflin, Mallory; Thomas, Brian F.; Marcu, Jahan P.; Hyke, Travis; Vandrey, Ryan G.

doi:10.1001/jama.2017.11909

Cited by 444 publications

(338 citation statements)

References 5 publications

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“…20 Comparatively, our subject received a significantly higher dose of CBD (up to 25 mg/kg/day). 18,21 As expected, lower doses of the artisanal CBD result in lower plasma CBD levels with peak concentrations for doses ≤20 mg typically <10 ng/mL (<0.03 μmol/L) with variability depending on the administration method. However, the steadystate plasma concentration of CBD achieved with the FDA-approved product at a dose of 25 mg/kg/day has been reported previously to range from 100 to 800 ng/mL (mean 450 ng/mL = 1.43 μmol/L).…”

Section: Discussionmentioning

confidence: 69%

“…14 However, per the package insert, CBD is not anticipated to interact with P-gp. 18 Inconsistencies in product makeup and changes in route of administration may result in variable exposure to the potentially interacting substances and in turn may increase the variability of CNI exposure. 10 To our knowledge, only one case report has been published pre- metabolized primarily by CYP3A4.…”

Section: Discussionmentioning

confidence: 99%

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Evidence of a clinically significant drug-drug interaction between cannabidiol and tacrolimus

Leino

Emoto

Fukuda

et al. 2019

American Journal of Transplantation

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Cannabidiol (CBD), a major purified nonpsychoactive component of cannabis with anticonvulsant properties, was approved by the U.S. Food and Drug Administration (FDA) in June 2018 as an adjuvant treatment for refractory epilepsy (Epidiolex; GW Pharmaceuticals). CBD is metabolized by cytochrome P450 (CYP)3A4 and CYP2C19 with a growing body of evidence suggesting it is also a potent inhibitor of these pathways. We report for the first time a significant drug‐drug interaction between the purified CBD product and tacrolimus. A participant in a CBD clinical trial for epilepsy who was also receiving tacrolimus showed an approximately 3‐fold increase in dose‐normalized tacrolimus concentrations while receiving 2000‐2900 mg/day of CBD. Our report delineates an important concern for the transplant community with the increasing legalization of cannabis and advent of an FDA‐approved CBD product. Larger studies are needed to better understand the impact of this drug‐drug interaction in solid organ transplant recipients.

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Section: Discussionmentioning

confidence: 69%

Section: Discussionmentioning

confidence: 99%

Evidence of a clinically significant drug-drug interaction between cannabidiol and tacrolimus

Leino

Emoto

Fukuda

et al. 2019

American Journal of Transplantation

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“…A recent study suggests caution should be exercised when purchasing products purported to contain CBD oil as only 30% of products were accurately labeled including about 43% that were underlabeled and about 26% that were overlabeled. Tetrahydrocannabinol was detected in about 20% of samples (Bonn‐Miller et al, ).…”

Section: Clinical Trialsmentioning

confidence: 99%

A multidisciplinary approach to the clinical management of Prader–Willi syndrome

Duis

Wattum

Scheimann

et al. 2019

Molec Gen & Gen Med

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Background Prader–Willi syndrome (PWS) is a complex neuroendocrine disorder affecting approximately 1/15,000–1/30,000 people. Unmet medical needs of individuals with PWS make it a rare disease that models the importance of multidisciplinary approaches to care with collaboration between academic centers, medical homes, industry, and parent organizations. Multidisciplinary clinics support comprehensive, patient‐centered care for individuals with complex genetic disorders and their families. Value comes from improved communication and focuses on quality family‐centered care. Methods Interviews with medical professionals, scientists, managed care experts, parents, and individuals with PWS were conducted from July 1 to December 1, 2016. Review of the literature was used to provide support. Results Data are presented based on consensus from these interviews by specialty focusing on unique aspects of care, research, and management. We have also defined the Center of Excellence beyond the multidisciplinary clinic. Conclusion Establishment of clinics motivates collaboration to provide evidence‐based new standards of care, increases the knowledge base including through randomized controlled trials, and offers an additional resource for the community. They have a role in global telemedicine, including to rural areas with few resources, and create opportunities for clinical work to inform basic and translational research. As a care team, we are currently charged with understanding the molecular basis of PWS beyond the known genetic cause; developing appropriate clinical outcome measures and biomarkers; bringing new therapies to change the natural history of disease; improving daily patient struggles, access to care, and caregiver burden; and decreasing healthcare load. Based on experience to date with a PWS multidisciplinary clinic, we propose a design for this approach and emphasize the development of “Centers of Excellence.” We highlight the dearth of evidence for management approaches creating huge gaps in care practices as a means to illustrate the importance of the collaborative environment and translational approaches.

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“…Nearly 43% of these products—including oils, tinctures, and vaporization liquid—contained more CBD than their labels promoted (Sherman ). Another 26% of the products actually contained less CBD than indicated (Bonn‐Miller et al ). Furthermore, THC was also found in significant quantities in about 21% of the products tested in the study.…”

Section: The “Dual Legality” Of Marijuana and Consumer‐related Hazardsmentioning

confidence: 89%

The Dual Legality of Marijuana in the United States: Implications of Conflicting Government Policies on Consumer Well‐being

Simkins¹,

Geiger-Oneto²

2019

Journal of Consumer Affairs

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Academics have recently become interested in the process by which socially controversial behaviors or practices (i.e., gambling, cosmetic procedures, drug use) become acceptable or legitimate. This article examines the “dual legality” of marijuana and its impact on consumer‐related hazards through the lens of current legislation and extant literature. Simply stated, what are the implications of conflicting government policies for consumers' well‐being? The intended contributions of this work are to offer significant insights into an issue of current topical and public policy importance for consumers' interests. Importantly, this work will serve as a foundation for future research on this unique product in its implications for consumers who are fundamentally altering the way in which a product is viewed and regulated.

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Labeling Accuracy of Cannabidiol Extracts Sold Online

Cited by 444 publications

References 5 publications

Evidence of a clinically significant drug-drug interaction between cannabidiol and tacrolimus

Evidence of a clinically significant drug-drug interaction between cannabidiol and tacrolimus

A multidisciplinary approach to the clinical management of Prader–Willi syndrome

The Dual Legality of Marijuana in the United States: Implications of Conflicting Government Policies on Consumer Well‐being

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