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Adverse effects of cannabidiol: a systematic review and meta-analysis of randomized clinical trials.

Published on Apr 8, 2020in Neuropsychopharmacology7.16
· DOI :10.1038/S41386-020-0667-2
Edward Chesney4
Estimated H-index: 4
('KCL': King's College London),
Dominic Oliver11
Estimated H-index: 11
('KCL': King's College London)
+ 5 AuthorsPhilip McGuire116
Estimated H-index: 116
(NIHR: National Institute for Health Research)
Abstract
Cannabidiol (CBD) is being investigated as a treatment for several medical disorders but there is uncertainty about its safety. We conducted the first systematic review and meta-analysis of the adverse effects of CBD across all medical indications. Double-blind randomized placebo-controlled clinical trials lasting >/=7 days were included. Twelve trials contributed data from 803 participants to the meta-analysis. Compared with placebo, CBD was associated with an increased likelihood of withdrawal for any reason (OR 2.61, 95% CI: 1.38-4.96) or due to adverse events (OR 2.65, 95% CI: 1.04-6.80), any serious adverse event (OR 2.30, 95% CI: 1.18-4.48), serious adverse events related to abnormal liver function tests (OR 11.19, 95% CI: 2.09-60.02) or pneumonia (OR 5.37, 95% CI: 1.17-24.65), any adverse event (OR 1.55, 95% CI: 1.03-2.33), adverse events due to decreased appetite (OR 3.56, 95% CI: 1.94-6.53), diarrhoea (OR 2.61, 95% CI: 1.46-4.67), somnolence (OR 2.23, 95% CI: 1.07-4.64) and sedation (OR 4.21, 95% CI: 1.18-15.01). Associations with abnormal liver function tests, somnolence, sedation and pneumonia were limited to childhood epilepsy studies, where CBD may have interacted with other medications such as clobazam and/or sodium valproate. After excluding studies in childhood epilepsy, the only adverse outcome associated with CBD treatment was diarrhoea (OR 5.03, 95% CI: 1.44-17.61). In summary, the available data from clinical trials suggest that CBD is well tolerated and has relatively few serious adverse effects, however interactions with other medications should be monitored carefully. Additional safety data from clinical trials outside of childhood epilepsy syndromes and from studies of over-the-counter CBD products are needed to assess whether the conclusions drawn from clinical trials can be applied more broadly.
  • References (35)
  • Citations (3)
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References35
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#1Geert Jan Groeneveld (LUMC: Leiden University Medical Center)H-Index: 2
#2Jennifer H. Martin (University of Newcastle)H-Index: 32
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: GW Pharmaceuticals' formulation of highly purified cannabidiol oral solution is approved in the United States for seizures associated with Lennox-Gastaut and Dravet syndromes in patients aged ≥2 years, for which clobazam, stiripentol, and valproate are commonly used antiepileptic drugs. This open-label, fixed-sequence, drug-drug interaction, healthy volunteer trial investigated the impact of cannabidiol on steady-state pharmacokinetics of clobazam (and N-desmethylclobazam), stiripentol, and va...
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The European Medicines Agency (EMA) has approved the first cannabis based medicine to treat two rare and severe forms of childhood onset epilepsy, although hurdles remain before the drug becomes available on the NHS. In August the National Institute for Health and Care Excellence (NICE) published draft guidance saying that on the current evidence it could not recommend cannabidiol as an effective use of NHS resources.1 However, it said it was working with the manufacturer GW Pharmaceuticals to t...
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#2Renata Solimini (ISS: Istituto Superiore di Sanità)H-Index: 13
Last. Francesco Paolo Busardò (Marche Polytechnic University)H-Index: 20
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BACKGROUND: Currently, there is a great interest in the potential medical use of cannabidiol (CBD), a non-intoxicating cannabinoid. Productive pharmacological research on CBD occurred in the 1970s and intensified recently with many discoveries about the endocannabinoid system. Multiple preclinical and clinical studies led to FDA-approval of Epidiolex®, a purified CBD medicine formulated for oral administration for the treatment of infantile refractory epileptic syndromes, by the US Food and Drug...
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Last. Michael A P BloomfieldH-Index: 11
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### What you need to know Until recently, cannabis and its derivatives were widely restricted under legislation which stated they had no medical value and carried a substantial risk of misuse. Policy is rapidly changing, and cannabis can now be prescribed for medicinal use in many countries, including the UK. This provides important new opportunities for treating patients although these need to be weighed up against potential risks. Several different medicinal products exist, with contrasting me...
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Abstract Rationale Treatment with a highly purified oral solution of cannabidiol (CBD), derived from the plant Cannabis sativa L., demonstrated some evidence of central nervous system (CNS)-related adverse events in patients enrolled in phase 3 trials for treatment of childhood-onset epilepsy. Cannabidiol was categorized as a Schedule 1 substance by the United States Drug Enforcement Administration; therefore, it was important to test CBD for human abuse potential. Methods This was a single-dose...
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#2Barry E. Gidal (UW: University of Wisconsin-Madison)H-Index: 40
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Cannabidiol (CBD) is a naturally occurring, non-psychotropic cannabinoid of the hemp plant Cannabis sativa L. and has been known to induce several physiological and pharmacological effects. While CBD is approved as a medicinal product subject to prescription, it is also widely sold over the counter (OTC) in the form of food supplements, cosmetics and electronic cigarette liquids. However, regulatory difficulties arise from its origin being a narcotic plant or its status as an unapproved novel fo...
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