References
- Research C for DE and. Prescription Drug User Fee Act (PDUFA). Enhancing benefit-risk assessment in regulatory decision-making [Internet]. [cited 2018 Jun 13]. Available from: https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm
- Office of Dietary Supplements. Dietary supplement health and education act of 1994 [Internet]. [cited 2016 Dec 17]. Available from: https://ods.od.nih.gov/About/DSHEA_Wording.aspx
- Morrow JD. Why the United States still needs improved dietary supplement regulation and oversight. Clin Pharmacol Ther. 2008;83(3):391–393.
- State medical marijuana laws [Internet]. [cited 2019 Jan 21]. Available from: http://www.ncsl.org/research/health/state-medical-marijuana-laws.aspx#3.
- Campos AC, Fogaça MV, Sonego AB, et al. Cannabidiol, neuroprotection and neuropsychiatric disorders. Pharmacol Res. 2016;112:119–127.
- Noreen N, Muhammad F, Akhtar B, et al. Is Cannabidiol a promising substance for new drug development? A review of its potential therapeutic applications. Crit Rev Eukaryot Gene Expr. 2018;28(1):73–86.
- Boychuk DG, Goddard G, Mauro G, et al. The effectiveness of cannabinoids in the management of chronic nonmalignant neuropathic pain: a systematic review. J Oral Facial Pain Headache. 2015;29(1):7–14.
- Research C for DE and. Investigational New Drug (IND) Application. Final rule: investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans [Internet]. [cited 2019 Mar 22]. Available from: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm226358.htm
- Pitts PJ, Louet HL, Moride Y, et al. 21st century pharmacovigilance: efforts, roles, and responsibilities. Lancet Oncol. 2016;17(11):e486–92.
- Solotke MT, Dhruva SS, Downing NS, et al. New and incremental FDA black box warnings from 2008 to 2015. Expert Opin Drug Saf. 2018;17(2):117–123.
- Qureshi ZP, Seoane-Vazquez E, Rodriguez-Monguio R, et al. Market withdrawal of new molecular entities approved in the United States from 1980 to 2009. Pharmacoepidemiol Drug Saf. 2011;20(7):772–777.
- Nutrition C for FS and A. Compliance & Enforcement - CFSAN Adverse Event Reporting System (CAERS) [Internet]. [cited 2019 Jan 19]. Available from: https://www.fda.gov/food/complianceenforcement/ucm494015.htm
- Thiele EA, Marsh ED, French JA, et al. Cannabidiol in patients with seizures associated with Lennox-Gastaut syndrome (GWPCARE4): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Lond Engl. 2018;391(10125):1085–1096.
- Devinsky O, Cross JH, Laux L, et al. Trial of cannabidiol for drug-resistant seizures in the dravet syndrome. N Engl J Med. 2017;376(21):2011–2020.
- Devinsky O, Patel AD, Cross JH, et al. Effect of cannabidiol on drop seizures in the lennox–gastaut syndrome. N Engl J Med. 2018;378(20):1888–1897.
- Collin C, Ehler E, Waberzinek G, et al. A double-blind, randomized, placebo-controlled, parallel-group study of Sativex, in subjects with symptoms of spasticity due to multiple sclerosis. Neurol Res. 2010;32(5):451–459.
- Novotna A, Mares J, Ratcliffe S, et al. A randomized, double-blind, placebo-controlled, parallel-group, enriched-design study of nabiximols*(Sativex®), as add-on therapy, in subjects with refractory spasticity caused by multiple sclerosis. Eur J Neurol. 2011;18(9):1122–1131.
- Collin C, Davies P, Mutiboko IK, et al. Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis. Eur J Neurol. 2007;14(3):290–296.
- Rekand T. THC:CBD spray and MS spasticity symptoms: data from latest studies. Eur Neurol. 2014;71(Suppl 1):4–9.
- Finniss DG, Kaptchuk TJ, Miller F, et al. Biological, clinical, and ethical advances of placebo effects. Lancet. 2010;375(9715):686–695.
- Bauer PR, Sander JW. Cannabidiol in patients with treatment-resistant epilepsy. Lancet Neurol. 2016;15(6):544.
- Pujar S, Calvert S, Cortina-Borja M, et al. Statistical process control (SPC)–a simple objective method for monitoring seizure frequency and evaluating effectiveness of drug interventions in refractory childhood epilepsy. Epilepsy Res. 2010;91(2–3):205–213.
- Martínez-Yélamos S, Martínez-Yélamos A, Ozaeta GM, et al. Regression to the mean in multiple sclerosis. Mult Scler J. 2006;12(6):826–829.
- Press CA, Knupp KG, Chapman KE. Parental reporting of response to oral cannabis extracts for treatment of refractory epilepsy. Epilepsy Behav. 2015;45:49–52.
- Russo EB. Current therapeutic cannabis controversies and clinical trial design issues. Front Pharmacol. 2016;7:309.
- Wright S, Duncombe P, Altman DG. Assessment of blinding to treatment allocation in studies of a cannabis-based medicine (Sativex®) in people with multiple sclerosis: a new approach. Trials. 2012;13:189.
- Zajicek J, Fox P, Sanders H, et al. Cannabinoids for treatment of spasticity and other symptoms related to multiple sclerosis (CAMS study): multicentre randomised placebo-controlled trial. Lancet Lond Engl. 2003;362(9395):1517–1526.
- Karschner EL, Darwin WD, McMahon RP, et al. Subjective and physiological effects after controlled sativex and oral THC administration. Clin Pharmacol Ther. 2011;89(3):400–407.
- Haney M, Malcolm RJ, Babalonis S, et al. Oral cannabidiol does not alter the subjective, reinforcing or cardiovascular effects of smoked cannabis. Neuropsychopharmacology. 2016;41(8):1974–1982.
- Notcutt W, Langford R, Davies P, et al. A placebo-controlled, parallel-group, randomized withdrawal study of subjects with symptoms of spasticity due to multiple sclerosis who are receiving long-term Sativex® (nabiximols). Mult Scler J. 2012;18(2):219–228.
- Jikomes N, Zoorob M. The cannabinoid content of legal cannabis in Washington State varies systematically across testing facilities and popular consumer products. Sci Rep. 2018;8(1):4519.
- Adams R, Hunt M, Clark JH. Structure of cannabidiol, a product isolated from the marihuana extract of minnesota wild hemp. I. J Am Chem Soc. 1940;62(1):196–200.
- Kilmer B, Pacula RL Estimating the size of the global drug market: A demand-side approach [Internet]. 2009 [cited 2018 Apr 21]. Available from: https://www.rand.org/pubs/technical_reports/TR711.html.
- Zlatko M, Suman C, Desmond S, et al. Potency Trends of Δ9‐THC and other cannabinoids in confiscated cannabis preparations from 1993 to 2008. J Forensic Sci. 2010;55(5):1209–1217.
- Ohlsson A, Lindgren J-E, Andersson S, et al. Single‐dose kinetics of deuterium‐labelled cannabidiol in man after smoking and intravenous administration. Biol Mass Spectrom. 1986;13(2):77–83.
- Suggested dosage – CBD garden health products [Internet]. [cited 2018 Apr 20]. Available from: http://cbdgarden.biz/index.php/cannabiniod-dosing-guidelines/
- CBD dosage - how much CBD oil should i take? CBD oil review [Internet]. [cited 2018 Apr 22]. Available from: https://cbdoilreview.org/cbd-cannabidiol/cbd-dosage/
- McGuire P, Robson P, Cubala WJ, et al. Cannabidiol (CBD) as an adjunctive therapy in schizophrenia: a multicenter randomized controlled trial. Am J Psychiatry. 2017;175(3):225–231.
- Leweke FM, Piomelli D, Pahlisch F, et al. Cannabidiol enhances anandamide signaling and alleviates psychotic symptoms of schizophrenia. Transl Psychiatry. 2012;2(3):e94.
- Freedman DA, Patel AD. Inadequate regulation contributes to mislabeled online cannabidiol products. Pediatr Neurol Briefs. 2018;32:3.
- Devinsky O, Cilio MR, Cross H, et al. Cannabidiol: pharmacology and potential therapeutic role in epilepsy and other neuropsychiatric disorders. Epilepsia. 2014;55(6):791–802.
- Devinsky O, Marsh E, Friedman D, et al. Cannabidiol in patients with treatment-resistant epilepsy: an open-label interventional trial. Lancet Neurol. 2016;15(3):270–278.
- Ujváry I, Hanuš L. Human metabolites of cannabidiol: a review on their formation, biological activity, and relevance in therapy. Cannabis Cannabinoid Res. 2016;1(1):90–101.
- Bih CI, Chen T, Nunn AVW, et al. Molecular targets of cannabidiol in neurological disorders. Neurotherapeutics. 2015;12(4):699–730.
- Russo C, Ferk F, Mišík M, et al. Low doses of widely consumed cannabinoids (cannabidiol and cannabidivarin) cause DNA damage and chromosomal aberrations in human-derived cells. Arch Toxicol. 2019;93(1):179–188.
- Ahmed KT, Amin MR, Shah P, et al. Motor neuron development in zebrafish is altered by brief (5-hr) exposures to THC (∆9-tetrahydrocannabinol) or CBD (cannabidiol) during gastrulation. Sci Rep. 2018;8(1):10518.
- Turgeman I, Bar-Sela G. Cannabis for cancer – illusion or the tip of an iceberg: a review of the evidence for the use of Cannabis and synthetic cannabinoids in oncology. Expert Opin Investig Drugs. 2019;28(3):285–296.
- Valim Brigante TA, Abe FR, Zuardi AW, et al. Cannabidiol did not induce teratogenicity or neurotoxicity in exposed zebrafish embryos. Chem Biol Interact. 2018;291:81–86.
- Sativex oromucosal spray. Summary of product characteristics (SmPC) - (eMC) [Internet]. [cited 2019 Mar 23]. Available from: https://www.medicines.org.uk/emc/product/602/smpc
- DailyMed - MARINOL- dronabinol capsule [Internet]. [cited 2019 Mar 23]. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5bbac0b1-ddc2-400b-8e0d-1e1d484720ca.
- Zajicek J, Sanders H, Wright D, et al. Cannabinoids in multiple sclerosis (CAMS) study: safety and efficacy data for 12 months follow up. J Neurol Neurosurg Psychiatry. 2005;76(12):1664–1669.
- DailyMed - EPIDIOLEX- cannabidiol solution [Internet]. [cited 2019 Mar 23]. Available from: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8bf27097-4870-43fb-94f0-f3d0871d1eec.
- Carrier EJ, Auchampach JA, Hillard CJ. Inhibition of an equilibrative nucleoside transporter by cannabidiol: A mechanism of cannabinoid immunosuppression. Proc Natl Acad Sci U S A. 2006;103(20):7895–7900.
- Dhital S, Park N, Seo KS, et al. Cannabidiol (CBD) induces functional CD4+ CD25+ FOXP3+ Tregs. J Immunol. 2016;196(1 Supplement):10–125.
- Lee C-Y, Wey S-P, Liao M-H, et al. A comparative study on cannabidiol-induced apoptosis in murine thymocytes and EL-4 thymoma cells. Int Immunopharmacol. 2008;8(5):732–740.
- Srivastava MD, Srivastava BI, Brouhard B. Delta9 tetrahydrocannabinol and cannabidiol alter cytokine production by human immune cells. Immunopharmacology. 1998;40(3):179–185.
- Weiss L, Zeira M, Reich S, et al. Cannabidiol lowers incidence of diabetes in non-obese diabetic mice. Autoimmunity. 2006;39(2):143–151.
- Herring AC, Hernández Y, Huffnagle GB, et al. Role and development of TH1/TH2 immune responses in the lungs. Semin Respir Crit Care Med. 2004;25(1):3–10.
- Stout SM, Cimino NM. Exogenous cannabinoids as substrates, inhibitors, and inducers of human drug metabolizing enzymes: a systematic review. Drug Metab Rev. 2014;46(1):86–95.
- Jiang R, Yamaori S, Okamoto Y, et al. Cannabidiol is a potent inhibitor of the catalytic activity of cytochrome P450 2C19. Drug Metab Pharmacokinet. 2013;28(4):332–338.
- Al Saabi A, Allorge D, Sauvage F-L, et al. Involvement of UDP-glucuronosyltransferases UGT1A9 and UGT2B7 in ethanol glucuronidation, and interactions with common drugs of abuse. Drug Metab Dispos Biol Fate Chem. 2013;41(3):568–574.
- Millar SA, Stone NL, Yates AS, et al. A systematic review on the pharmacokinetics of cannabidiol in humans. Front Pharmacol [ [Internet]]. 2018 [cited 2019 Mar 24]; 9, Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6275223/
- Manini AF, Yiannoulos G, Bergamaschi MM, et al. Safety and pharmacokinetics of oral cannabidiol when administered concomitantly with intravenous fentanyl in humans. J Addict Med. 2015;9(3):204–210.
- Devinsky O, Patel AD, Thiele EA, et al. Randomized, dose-ranging safety trial of cannabidiol in Dravet syndrome. Neurology. 2018;90(14):e1204–11.
- Gronewold A, Skopp G. A preliminary investigation on the distribution of cannabinoids in man. Forensic Sci Int. 2011;210(1):e7–11.
- Gaston TE, Bebin EM, Cutter GR, et al., UAB CBD Program. Interactions between cannabidiol and commonly used antiepileptic drugs. Epilepsia. 2017;58(9):1586–1592.
- Geffrey AL, Pollack SF, Bruno PL, et al. Drug–drug interaction between clobazam and cannabidiol in children with refractory epilepsy. Epilepsia. 2015;56(8):1246–1251.
- Haigh JR, Pullar T, Gent JP, et al. N‐desmethylclobazam: a possible alternative to clobazam in the treatment of refractory epilepsy? Br J Clin Pharmacol. 2012;23(2):213–218.
- Spina E, de Leon J. Metabolic drug interactions with newer antipsychotics: a comparative review. Basic Clin Pharmacol Toxicol. 2007;100(1):4–22.
- Porcari GS, Fu C, Doll ED, et al. Efficacy of artisanal preparations of cannabidiol for the treatment of epilepsy: practical experiences in a tertiary medical center. Epilepsy Behav. 2018;80:240–246.
- Grayson L, Vines B, Nichol K, et al., UAB CBD Program. An interaction between warfarin and cannabidiol, a case report. Epilepsy Behav Case Rep. 2018;9:10–11.
- Yamreudeewong W, Wong HK, Brausch LM, et al. Probable interaction between warfarin and marijuana smoking. Ann Pharmacother. 2009;43(7–8):1347–1353.
- Gaston T, Cutter G, Liu Y, et al. Effect of pharmaceutical formulation of purified cannabidiol (CBD) on seizure frequency and severity is independent of drug-drug interactions with other anti-epileptic drugs (AEDs) (P4.271). Neurology [Internet]. 2018;90(15 Supplement). Available from: http://n.neurology.org/content/90/15_Supplement/P4.271.abstract
- Pamplona FA, Da Silva LR, Coan AC. Potential clinical benefits of CBD-rich cannabis extracts over purified CBD in treatment-resistant epilepsy: observational data meta-analysis. Front Neurol. 2018;9:759.
- Russo EB. The case for the entourage effect and conventional breeding of clinical cannabis: no “strain,” no gain. Front Plant Sci. 2018;9:1969.
- Wolff V, Jouanjus E. Strokes are possible complications of cannabinoids use. Epilepsy Behav. 2017;70:355–363.
- Solowij N, Broyd S, Greenwood L, et al. A randomised controlled trial of vaporised Δ9-tetrahydrocannabinol and cannabidiol alone and in combination in frequent and infrequent cannabis users: acute intoxication effects. Eur Arch Psychiatry Clin Neurosci [Internet]. 2019 [cited2019 Jan 28]. DOI:10.1007/s00406-019-00978-2.
- Johns A. Psychiatric effects of cannabis. Br J Psychiatry. 2001;178(2):116–122.
- DiMasi JA, Grabowski HG, Hansen RW. Innovation in the pharmaceutical industry: new estimates of R&D costs. J Health Econ. 2016;47:20–33.
- Harrison RK. Phase II and phase III failures: 2013–2015. Nat Rev Drug Discov. 2016;15(12):817–818.
- Jüni P, Nartey L, Reichenbach S, et al. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet. 2004;364(9450):2021–2029.
- Krumholz HM, Ross JS, Presler AH, et al. What have we learnt from Vioxx? BMJ Br Med J Lond. 2007;334(7585):120–123.
- Mittleman MA, Lewis RA, Maclure M, et al. Triggering myocardial infarction by marijuana. Circulation. 2001;103(23):2805–2809.
- Martínez ME, Jacobs ET, Baron JA, et al. Dietary supplements and cancer prevention: balancing potential benefits against proven harms. JNCI J Natl Cancer Inst. 2012;104(10):732–739.
- Salottolo K, Peck L, Tanner A II, et al. The grass is not always greener: a multi-institutional pilot study of marijuana use and acute pain management following traumatic injury. Patient Saf Surg. 2018;12(1):16.
- Sorensen CJ, DeSanto K, Borgelt L, et al. Cannabinoid hyperemesis syndrome: diagnosis, pathophysiology, and treatment—a systematic review. J Med Toxicol. 2017;13(1):71–87.
- Quinones RL, Winsor RD, Patino A, et al. The regulation of dietary supplements within the United States: flawed attempts at mending a defective consumer safety mechanism. J Consum Aff. 2013;47(2):328–357.
- Timbo BB, Chirtel SJ, Ihrie J, et al. Dietary supplement adverse event report data from the FDA center for food safety and applied nutrition adverse event reporting system (CAERS), 2004–2013. Ann Pharmacother. 2018;52(5):431–438.
- Corroon J, Phillips JA. A cross-sectional study of cannabidiol users. Cannabis Cannabinoid Res. 2018;3(1):152–161
- CBD information for cancer [Internet]. Cannabidiol Life. [cited 2018 Jul 21]. Available from: https://cbdoilsandedibles.com/cbd-for-cancer/
- How cannabis oil works to kill cancer [Internet]. www.CureYourOwnCancer.org. [cited 2018 Jul 21]. Available from: http://www.cureyourowncancer.org/how-cannabis-oil-works.html
- Dickson B, Mansfield C, Guiahi M, et al. Recommendations from cannabis dispensaries about first-trimester cannabis use. Obstet Gynecol. 2018;131(6):1031.
- Gardiner P, Sadikova E, Filippelli AC, et al. Medical reconciliation of dietary supplements: don’t ask, don’t tell. Patient Educ Couns. 2015;98(4):512–517.
- Tarn DM, Karlamangla A, Coulter ID, et al. A cross-sectional study of provider and patient characteristics associated with outpatient disclosures of dietary supplement use. Patient Educ Couns. 2015;98(7):830–836.
- International Drug Scheduling. Convention on psychotropic substances; single convention on narcotic drugs; world health organization; scheduling recommendations; dronabinol delta [Internet]. Fed. Regist. 2019 [cited 2019 Mar 26]. Available from: https://www.federalregister.gov/documents/2019/03/01/2019-03662/international-drug-scheduling-convention-on-psychotropic-substances-single-convention-on-narcotic
- DEA rejects attempt to loosen federal restrictions on marijuana [Internet]. NPR.org. [cited 2018 Jun 14]. Available from: https://www.npr.org/2016/08/10/489509471/dea-rejects-attempt-to-loosen-federal-restrictions-on-marijuana.
- FDA-approved drug Epidiolex placed in schedule V of controlled substance act [Internet]. [cited 2019 Jan 19]. Available from: https://www.dea.gov/press-releases/2018/09/27/fda-approved-drug-epidiolex-placed-schedule-v-controlled-substance-act.
- Conaway KM. Text - H.R.2–115th congress (2017–2018): agriculture improvement act of 2018 [Internet]. 2018 [cited 2019 Mar 27]. Available from: https://www.congress.gov/bill/115th-congress/house-bill/2/text
- Office of the Commissioner C for DE and R. Prescription drug marketing act of 1987 [Internet]. [cited 2019 Jan 23]. Available from: https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/PrescriptionDrugMarketingActof1987/default.htm
- Commissioner O of the. Public Health Focus. FDA and marijuana: questions and answers [Internet]. [cited 2019 Mar 27]. Available from: https://www.fda.gov/newsevents/publichealthfocus/ucm421168.htm#dietary_supplements