cannabidiol and Drug-Related-Side-Effects-and-Adverse-Reactions

Topics: Cannabidiol; COVID-19; Drug-Related Side Effects and Adverse Reactions; Humans; Inflammation; Randomized Controlled Trials as Topic; SARS-CoV-2; Treatment Outcome

Topics: Adult; Cannabidiol; Cannabis; Child; Chronic Pain; Clinical Trials as Topic; Dronabinol; Drug-Related Side Effects and Adverse Reactions; Humans

To date, very few cannabis-based specialities are authorised on the French market despite a growing demand from patients and health professionals. The objective of this study is to review the tolerance profile and the French legislative status of the two main cannabinoids used for therapeutic purposes: tetrahydrocannabiol (THC) associated with psychoactive effects and non-psychoactive cannabidiol (CBD).. This review is based on relevant articles retrieved by a search in Google Scholar and PubMed databases and on an assessment of the legal texts and summaries of product characteristics available in France.. Evidence for the tolerability of CBD during chronic use is reassuring, but a significant risk of drug interactions exists. THC use appears to be associated with a higher proportion of serious adverse effects, including neuropsychological and cardiovascular effects. Inhaled cannabis appears to be associated with greater toxicity than the oral route. These data are presented together with the pharmacokinetic and pharmacodynamic data of THC and CBD.. The literature reports several frequent but rarely serious adverse effects of CBD during chronic use as well as a significant risk of drug interactions. THC use seems to be associated with a higher proportion of serious adverse effects compared to CBD, particularly at the neuropsychological and cardiovascular levels. Health professionals should be up to date on the particularities of therapeutic cannabis in terms of efficacy, safety and drug interactions.

Topics: Cannabidiol; Cannabinoids; Cannabis; Dronabinol; Drug-Related Side Effects and Adverse Reactions; Humans; Plant Extracts

Chronic musculoskeletal (MSK) pain is one of the most prevalent causes, which lead patients to a physician's office. The most common disorders affecting MSK structures are osteoarthritis, rheumatoid arthritis, back pain, and myofascial pain syndrome, which are all responsible for major pain and physical disability. Although there are many known management strategies currently in practice, phytotherapeutic compounds have recently begun to rise in the medical community, especially cannabidiol (CBD). This natural, non-intoxicating molecule derived from the cannabis plant has shown interesting results in many preclinical studies and some clinical settings. CBD plays vital roles in human health that go well beyond the classic immunomodulatory, anti-inflammatory, and antinociceptive properties. Recent studies demonstrated that CBD also improves cell proliferation and migration, especially in mesenchymal stem cells (MSCs). The foremost objective of this review article is to discuss the therapeutic potential of CBD in the context of MSK regenerative medicine. Numerous studies listed in the literature indicate that CBD possesses a significant capacity to modulate mammalian tissue to attenuate and reverse the notorious hallmarks of chronic musculoskeletal disorders (MSDs). The most of the research included in this review report common findings like immunomodulation and stimulation of cell activity associated with tissue regeneration, especially in human MSCs. CBD is considered safe and well tolerated as no serious adverse effects were reported. CBD promotes many positive effects which can manage detrimental alterations brought on by chronic MSDs. Since the application of CBD for MSK health is still undergoing expansion, additional randomized clinical trials are warranted to further clarify its efficacy and to understand its cellular mechanisms.

Topics: Animals; Cannabidiol; Cannabis; Chronic Pain; Drug-Related Side Effects and Adverse Reactions; Humans; Mammals; Regenerative Medicine

Topics: Cannabidiol; Cannabinoids; Cannabis; Drug-Related Side Effects and Adverse Reactions; Hallucinogens; Humans; Parkinson Disease

The aim of this current report was to present a critical review of the use of cannabidiol (CBD) in the treatment of refractory epilepsies in the pediatric population.. Literature review was carried out in the Medline (PubMed), Cochrane, and Scientific Electronic Library Online (SciELO) databases with the descriptors "Cannabidiol" and "Epilepsy." The search was not limited by the date of publication, language, or study design. A total of 69 articles were included in the review.. The efficacy of CBD in treating epileptic seizures has been confirmed by randomized controlled trials for Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex. The incidence of side effects reported in subjects of the studies is high. However, most studies indicate a good safety profile and tolerance to the drug, with most of the adverse effects being mild to moderate and transient.. There is no consensus on the release of CBD as a therapeutic tool by the drug regulatory agencies worldwide. However, the use of CBD is promising since it has presented satisfactory results in crisis control in well-designed studies. In addition, this drug has a good safety and tolerance profile. However, further studies with a long follow-up period are needed to confirm its usefulness and the long-term safety in pediatric patients.

Topics: Anticonvulsants; Cannabidiol; Child; Drug Resistant Epilepsy; Drug-Related Side Effects and Adverse Reactions; Epilepsy; Humans; Lennox Gastaut Syndrome

Medicinal cannabis prescriptions are on the rise in Australia, and general practitioners will increasingly encounter patients using cannabis-based products.. The aim of this review is to provide a primer on the safety issues that need to be considered with medicinal cannabis.. Medicinal cannabis is generally well tolerated when dosed appropriately. It is important for doctors to consider carefully the Δ9-tetrahydrocannabinol (THC) and/or cannabidiol (CBD) content of the products. CBD is not intoxicating and has fewer safety concerns than THC. When commencing a new medicinal cannabis product, the recommendation is to prescribe relatively low doses and slowly up-titrate the dose. This aims to minimise dose-related toxicities and the potential for drug-drug interactions with concomitant medications. THC found in medicinal cannabis may acutely impair cognitive function and is best not prescribed to children or adolescents unless the benefits outweigh the risks. THC-containing cannabis products should not be prescribed to individuals with angina or a history of myocardial infarction, or to those who have a personal or family history of psychosis.

Topics: Adolescent; Cannabidiol; Cannabis; Child; Dronabinol; Drug-Related Side Effects and Adverse Reactions; Humans; Medical Marijuana

The role of cannabis in medicine is rapidly evolving. Medical cannabis is now legal in a majority of states, and THC and CBD, the prominent cannabinoids found in cannabis, have both been utilized in the development of FDA-approved drugs. Due to the complicated legal status of cannabis and cannabinoids, as well as regulations that vary from state to state, the appropriate use of these substances for both patients as well as clinicians is often unclear. Advancements in the understanding of the pharmacology of cannabis have led to numerous proposed uses of these drugs, including as antidepressant or analgesic agents. However, clinical trial data for these substances suggests that many purported indications of cannabis and cannabinoids are not supported by good clinical data. Furthermore, cannabis and several cannabinoid-based medications have potentially concerning side effect profiles that may limit their use in certain patient populations. As the legal status and clinical database of these medications continue to evolve, physicians will need to continue to balance the real potential of these compounds with their limitations and adverse effects.

Topics: Analgesics; Cannabidiol; Cannabinoids; Cannabis; Dronabinol; Drug-Related Side Effects and Adverse Reactions; Humans; Medical Marijuana; United States

Epidiolex® (CBD) is FDA-approved for seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), and tuberous sclerosis complex (TSC). Phase III studies suggest that certain adverse effects (AEs), possibly linked to pharmacokinetic/pharmacodynamic (PK/PD) interactions may be therapy-limiting. We sought to identify these factors that contribute to treatment success and retention of therapy.. A single-center, retrospective review of patients with refractory epilepsy taking Epidiolex® was performed. Kaplan-Meier analysis was performed to describe Epidiolex® retention, as a measure of overall effectiveness.. One hundred and twelve patients were screened; 4 were excluded due to loss to follow-up or never starting Epidiolex®. Of 108 patients, mean age was 20.3 years (13.1, range 2 to 63), and 52.8% were female. Mean initial and maintenance doses were 5.3 mg/kg/day (1.3) and 15.3 mg/kg/day (5.8), respectively. At the final evaluation, 75% of patients remained on Epidiolex®. The 25th percentile for discontinuation was 19 months. 46.3% of patients experienced at least one treatment-emergent adverse effect (TEAE) with 14.5% d/c Epidiolex® due to treatment emerging adverse effects (TEAE). The most common reasons for discontinuation were lack of efficacy (37%), increased seizure activity (22%), worsened behavior (22%), and sedation (22%). One out of 27 discontinuations was due to liver function test (LFT) elevations (3.7%). At initiation, 47.2% were concurrently taking clobazam, and 39.2% of those patients had an initial clobazam dose decrease. 53% of patients were able to either discontinue or lower the dose of at least one other antiseizure medication.. Epidiolex® is generally well-tolerated and the majority continued long-term treatment. Patterns of adverse effects were similar to clinical trials, however gastrointestinal complaints, and significant LFT elevations were less common. Our data suggest most patients discontinue within the first several months of treatment and suggest that further studies designed to evaluate early identification and potential mitigation of adverse effects and including drug interactions are warranted.

Topics: Adolescent; Adult; Anticonvulsants; Cannabidiol; Child; Child, Preschool; Clobazam; Drug Resistant Epilepsy; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Lennox Gastaut Syndrome; Male; Middle Aged; Seizures; Young Adult

Several works have reported on the antiepileptic impact of cannabis-based preparations in patients with treatment-resistant epilepsy (TRE). However, current formulations suffer from low bioavailability and side effects. PTL-101, an oral formulation containing highly purified cannabidiol (CBD) embedded in seamless gelatin matrix beadlets was designed to enhance bioavailability and maintain a constant gastrointestinal transit time.. This phase II, prospective study was open to pediatric patients with TRE on stable antiepileptic drugs' (AEDs) doses, who experienced ≥4 seizures within four weeks of enrolment and with a history of ≥4 AEDs failing to provide seizure control. Following a 4-week observation period, patients began a 2-week dose-titration phase (up to ≤25mg/kg or 450mg, the lower of the two), followed by a 10-week maintenance treatment period. Caregivers recorded seizure frequency, type, and severity and ranked their global impressions after 7 and 12weeks of treatment. Responders were those showing a ≥50% reduction from baseline monthly seizure frequency. Safety assessments monitored vital signs, adverse effects, physical and neurological exams, and laboratory tests.. Sixteen patients (age: 9.1±3.4) enrolled in the study; 11 completed the full treatment program. The average maintenance dose was 13.6±4.2mg/kg. Patient adherence to treatment regimens was 96.3±9.9%. By the end of the treatment period, 81.9% and 73.4±24.6% (p<0.05) reductions from baseline median seizure count and monthly seizure frequency, respectively, were recorded. Responders' rate was 56%; two patients became fully seizure-free. By study end, 8 (73%) caregivers reported an improved/very much improved condition, and 9 (82%) reported reduced/very much reduced seizure severity. Most commonly reported treatment-related adverse effects were sleep disturbance/insomnia, (4 (25.0%) patients), followed by somnolence, increased seizure frequency, and restlessness (3 patients each (18.8%)). None were serious or severe, and all resolved.. PTL-101 was safe and tolerable for use and demonstrated a potent seizure-reducing effect among pediatric patients with TRE.

Topics: Administration, Oral; Adolescent; Anticonvulsants; Cannabidiol; Child; Child, Preschool; Drug Compounding; Drug Resistant Epilepsy; Drug Therapy, Combination; Drug-Related Side Effects and Adverse Reactions; Female; Humans; Male; Prospective Studies; Treatment Outcome

Access to cannabis and cannabinoid products is increasing worldwide for recreational and medicinal use. Two primary compounds within cannabis plant matter, Δ

Topics: Adolescent; Adult; Blood Pressure; Cannabidiol; Cannabinoid Receptor Modulators; Cannabis; Dissociative Disorders; Dronabinol; Drug Interactions; Drug-Related Side Effects and Adverse Reactions; Female; Heart Rate; Humans; Male; Middle Aged; Perceptual Disorders; Self Report; Young Adult

Cannabidiol (CBD) is approved for treatment of Dravet syndrome (DS), Lennox-Gastaut syndrome (LGS), and tuberous sclerosis complex (TSC). Several studies suggest antiseizure effects also beyond these three epilepsy syndromes.. In a retrospective multicenter study, we analyzed the efficacy and tolerability of CBD in patients with epilepsy at 16 epilepsy centers.. The study cohort comprised 311 patients with epilepsy with a median age of 11.3 (0-72) years (235 children and adolescents, 76 adults). Therapy with CBD was off-label in 91.3% of cases due to age, epilepsy subtype, lack of adjunct therapy with clobazam, and/or higher dose applied. CBD titration regimens were slower than recommended, with good tolerability of higher doses particularly in children. Of all patients, 36.9% experienced a reduction in seizure frequency of >50%, independent of their epilepsy subtype or clobazam co-medication. The median observation period was 15.8 months. About one third of all patients discontinued therapy within the observation period due to adverse effects or lack of efficacy. Adverse effects were reported frequently (46.9%).. Our study highlights that CBD has an antiseizure effect comparable to other antiseizure medications with a positive safety profile independent of the epilepsy subtype. Comedication with clobazam was not associated with a better outcome. Higher doses to achieve seizure frequency reduction were safe, particularly in children. These findings call for further trials for an extended approval of CBD for other epilepsy subtypes and for children <2 years of age.

Topics: Adolescent; Adult; Aged; Anticonvulsants; Cannabidiol; Child; Clobazam; Drug-Related Side Effects and Adverse Reactions; Epilepsy; Humans; Middle Aged; Retrospective Studies; Seizures; Young Adult

Epidiolex, the first FDA-approved drug with cannabis extract, treats Dravet and Lennox-Gastaut syndromes. Using data from the FAERS database between 2018 and 2023, this study analyzed 13,275 Epidiolex-related adverse events. Through computational methods (ROR, PRR, BCPNN, EBGM), we found that real-world adverse reactions largely align with those in Epidiolex's drug leaflet. However, Seizure cluster, Blood ketone body decrease, Cortical visual impairment, Hyperactive pharyngeal reflex, and Poverty of speech emerged as potential new side effects not previously listed, warranting further attention for drug safety.

Topics: Adverse Drug Reaction Reporting Systems; Cannabidiol; Drug-Related Side Effects and Adverse Reactions; Humans; Software; United States; United States Food and Drug Administration

Cannabis contains over 500 distinct compounds, which include cannabinoids, terpenoids, and flavonoids. However, very few of these compounds have been studied for their beneficial effects. There is an emerging concept that the constituents of the cannabis plant may work in concert to achieve better therapeutic benefits. This study is aimed at determining if the combination of a minor cannabinoid (cannabidiol, CBD) and a terpene (beta-caryophyllene, BCP) works in concert and if this has any therapeutic value. We used an inflammatory pain model (formalin) in mice to test for any functionality of CBD and BCP in combination. First, we determined the analgesic effect of CBD and BCP individually by establishing dose-response studies. Second, we tested the analgesic effect of fixed-ratio combinations and monitored any adverse effects. Finally, we determined the effect of this combination on inflammation. The combination of CBD and BCP produces a synergistic analgesic effect. This effect was without the cannabinoid receptor-1 side effects. The analgesic effect of CBD and BCP in combination involves an inflammatory mechanism. The combination of these two constituents of the cannabis plant, CBD and BCP, works in concert to produce a therapeutic effect with safety profiles through an inflammatory mechanism.

Topics: Analgesics; Animals; Cannabidiol; Cannabinoids; Cannabis; Dronabinol; Drug-Related Side Effects and Adverse Reactions; Mice; Polycyclic Sesquiterpenes; Terpenes

A special component of cannabis, cannabidiol (CBD), is currently in the focus of epilepsy treatment and research. In this context, we investigated patients' expectations and preferences pertaining to plant-derived versus synthetic formulation of cannabidiol, as well as their willingness to get this treatment.. One hundred and four of 153 patients with different forms of epilepsy (54 % female, mean age 40 ± 16 yrs.) responded to the survey. The survey consisted of 8 questions addressing expectations of and concerns towards CBD treatment, preferences of plant-derived versus synthetic CBD, estimated monthly costs, and willingness to buy CBD at one's own expense.. The majority (73 %) of the responding epilepsy patients wished to receive plant-derived CBD; 5 % preferred synthetic CBD. Reasons for this choice were botanic origin, lack of chemistry, and the assumption of fewer and less dangerous side effects. Eighty-two percent of the patients estimated the monthly costs of CBD treatment to be below €500. Using the willingness-to-pay approach to assess the commitment of patients, 68 % could imagine buying the drug themselves. Fifty-three percent of these would be willing to pay up to €100, 40 % €100 to €200, and another 7 % €200 to €500 per month.. There is an overwhelming preference towards plant-derived cannabidiol in epilepsy patients, driven by the idea of organic substances being safer and better tolerated than synthetic. The willingness-to-pay approach reflects the high burden and pressure of uncontrolled epilepsy and the expectation of relief. Non-realistic ideas of pricing as well as what patients would be willing and able to pay confirm this perception.

Topics: Adolescent; Anticonvulsants; Cannabidiol; Cannabis; Drug-Related Side Effects and Adverse Reactions; Epilepsy; Female; Humans; Male

Cannabidiol (CBD) in hemp oil has become a widely used product in veterinary medicine. To date, there have been no reports of cutaneous adverse events associated with CBD-containing oil in the veterinary literature.. A 4-year-old castrated male Labrador retriever presented with pad sloughing and rapidly progressive cutaneous and mucosal ulceration within five days of administering an oral CBD oil product. Histopathological findings in combination with cutaneous signs were consistent with Stevens-Johnson syndrome. All lesions completely resolved after discontinuation of the hemp oil in addition to a 12 day course of cephalexin and prednisone. Given the lack of alternative causes including other medications, an adverse drug event was deemed probable according to the Naranjo algorithm.. To the best of the authors' knowledge, this is the first report of suspected cutaneous adverse drug reaction to a CBD-containing hemp oil product.. Le cannabidiol (CBD) dans l’huile de chanvre est un produit largement utilisé en médecine vétérinaire. A ce jour, aucun effet indésirable cutané n’a été décrit en association avec l’huile contenant du CBD dans la littérature vétérinaire. RÉSUMÉ CLINIQUE: Un Labrador retriever mâle castré de 4 ans, présenté pour décollement des coussinets et ulcération progressive rapide de la peau et des muqueuses après cinq jours d’administration d’un produit oral contenant du CBD. Les données histopathologiques associées aux signes cliniques étaient compatibles avec un syndrome de Stevens-Johnson. Toutes les lésions se sont totalement résolues avec l’arrêt de l’administration de l’huile de chanvre et de 12 jours de céphalexine et prednisone. Compte tenu de l’absence d’autres causes comme d’autres médicaments, la réaction médicamenteuse était fortement probable selon l’algorithme de Naranjo.. A la connaissance des auteurs, ceci est la première description d’une réaction cutanée médicamenteuse liée à de l’huile de chanvre contenant du CBD.. INTRODUCCIÓN: el cannabidiol (CBD) en el aceite de cáñamo se ha convertido en un producto ampliamente utilizado en pacientes veterinarios. Hasta la fecha, no ha habido informes de efectos adversos cutáneos asociados con el aceite que contiene CBD en la literatura veterinaria. RESUMEN CLÍNICO: un perro labrador macho castrado de 4 años presentó desprendimiento de la almohadilla y ulceración cutánea y de mucosas rápidamente progresiva a los cinco días posteriores a la administración de un producto de aceite de CBD oral. Los hallazgos histopatológicos en combinación con signos cutáneos fueron indicativos de un síndrome de Stevens-Johnson. Todas las lesiones se resolvieron por completo después de la interrupción de la administración de aceite de cáñamo, además de un curso de 12 días de cefalexina y prednisona. Dada la falta de causas alternativas que incluyen otros medicamentos, el efecto adverso del fármaco se consideró probable según el algoritmo de Naranjo. CONCLUSIONES E IMPORTANCIA CLÍNICA: a entender de los autores, este es el primer informe de sospecha de reacción cutánea adversa a un producto de aceite de cáñamo que contiene CBD.. Cannabiol (CBD) in Hanföl ist bei veterinärmedizinischen Patienten ein weitverbreitet eingesetztes Produkt geworden. Bis zum heutigen Tag gibt es in der Veterinärliteratur keine Berichte über kutane Nebenwirkungen im Zusammenhang mit CBD-enthaltenden Tropfen.. Ein 4 Jahre alter kastrierter Labrador Retrieverrüde wurde mit sich ablösenden Zehenballen und einer rasch fortschreitenden kutanen und mukokutanen Ulzeration, welche innerhalb von fünf Tagen nach Verabreichung eines CBD Ölprodukts per os begann, vorgestellt. Histopathologische Befunde in Kombination mit kutanen Zeichen stimmten mit dem Stevens-Johnson Syndrom überein. Alle Veränderungen heilten nach Absetzen des Hanföls und einer 12 tägigen Verabreichung von Cephalexin und Prednisolon völlig ab. Da es kaum andere Gründe, auch keine andere Medikation gab, wurde eine Nebenwirkungsreaktion dem Naranjo Algorithmus folgend für wahrscheinlich gehalten.. Nach bestem Wissen der Autoren handelt es sich hierbei um den ersten Bericht einer vermeintlichen kutanen Nebenwirkungsreaktion auf ein CBD-hältiges Hanfölprodukt.. 背景: 麻油に含まれるカンナビジオール（CBD）は、獣医療患者に広く使用される製品になった。今日まで、獣医学文献にはCBD含有油に関連する皮膚有害事象の報告はない。 臨床要約: 4歳、去勢雄のラブラドール・レトリバーは、経口CBDオイル製品を投与してから5日以内に、パッドの脱落、皮膚および粘膜の潰瘍が急速に進行した。皮膚兆候と組み合わせた組織病理学的所見は、スティーブンス・ジョンソン症候群と一致していた。セファレキシンおよびプレドニゾンの12日間コースに加え、麻油の中止後にすべての病変が完全に解消した。他の薬物療法を含む代替の原因がないため、Naranjoアルゴリズムによると、薬物有害事象は可能性が高いと見なされた。 結論と臨床的重要性: 著者の知る限り、これはCBD含有麻油製品に対する皮膚の副作用の疑いの最初の報告である。.. 背景: 大麻油中的大麻二酚(CBD)已成为兽医病例中被广泛使用的产品。迄今为止，在兽医文献中尚未报告CBD油可引起皮肤不良反应。 临床总结: 一只4岁去势雄性拉布拉多犬在口服CBD油产品后，5天内出现爪垫脱落和快速发展的皮肤和粘膜溃疡。组织病理学结果结合皮肤体征符合斯蒂文森强森综合征。除12天疗程的头孢氨苄和泼尼松外，停用大麻油后，所有病变均完全消退。由于缺乏其他原因（包括其他药物），根据纳兰霍算法，认为很可能是药物不良反应。 结论和临床重要性: 据作者所知，这是首次报告怀疑含CBD大麻油产品导致皮肤药物不良反应。.. O canabidiol (CBD) em óleo de cânhamo tornou-se um produto amplamente utilizado em pacientes veterinários. Até o momento, não há relatos de eventos adversos cutâneos associados ao óleo contendo CBD na literatura veterinária. RESUMO CLÍNICO: Um cão Labrador macho castrado de 4 anos de idade apresentou descamação e ulceração cutânea e mucosa rapidamente progressiva dentro de cinco dias após a administração de um produto à base de óleo de CBD por via oral. Os achados histopatológicos em combinação com os sinais cutâneos foram consistentes com a síndrome de Stevens-Johnson. Todas as lesões foram completamente resolvidas após a descontinuação do óleo de cânhamo, além de um curso de 12 dias de cefalexina e prednisona. Dada a falta de causas alternativas, incluindo outros medicamentos, o evento adverso ao medicamento foi considerado provável, de acordo com o algoritmo de Naranjo. CONCLUSÕES E IMPORTÂNCIA CLÍNICA: Segundo o conhecimento dos autores, este é o primeiro relato de suspeita de reação adversa cutânea a medicamentos causada por um produto à base de óleo de cânhamo contendo CBD.

Topics: Administration, Cutaneous; Animals; Cannabidiol; Cannabis; Dog Diseases; Dogs; Drug-Related Side Effects and Adverse Reactions

The prior medical literature offers little guidance as to how pain relief and side effect manifestation may vary across commonly used and commercially available cannabis product types. We used the largest dataset in the United States of real-time responses to and side effect reporting from patient-directed cannabis consumption sessions for the treatment of pain under naturalistic conditions in order to identify how cannabis affects momentary pain intensity levels and which product characteristics are the best predictors of therapeutic pain relief. Between 06/06/2016 and 10/24/2018, 2987 people used the ReleafApp to record 20,513 cannabis administration measuring cannabis' effects on momentary pain intensity levels across five pain categories: musculoskeletal, gastrointestinal, nerve, headache-related, or non-specified pain. The average pain reduction was -3.10 points on a 0-10 visual analogue scale (SD = 2.16, d = 1.55, p < .001). Whole Cannabis flower was associated with greater pain relief than were other types of products, and higher tetrahydrocannabinol (THC) levels were the strongest predictors of analgesia and side effects prevalence across the five pain categories. In contrast, cannabidiol (CBD) levels generally were not associated with pain relief except for a negative association between CBD and relief from gastrointestinal and non-specified pain. These findings suggest benefits from patient-directed, cannabis therapy as a mid-level analgesic treatment; however, effectiveness and side effect manifestation vary with the characteristics of the product used.

Topics: Analgesics; Cannabidiol; Cannabis; Dronabinol; Drug-Related Side Effects and Adverse Reactions; Flowers; Humans; Medical Marijuana; Pain

Useof cannabidiol oil in children The use of cannabidioloil (CBD oil), a cannabis-derived chemical, is increasing. CBD oil is freely available in the Netherlands, but its composition and quality are not monitored. However, the alternative, pharmacist-prepared oil, is more expensive and difficult to acquire. Common reasons for CBD oil use in children include impulsive behaviour, itch, epilepsy, stress, pain and sleeping problems. However, evidence of its effectiveness is scarce and focuses primarily on the effectiveness of the oil in reducing epileptic seizures. Known side-effects are vomiting, diarrhoea, fever, sleepiness, and abnormal liver function test results. We advise medical professionals who encounter young patients who may potentially be using CBD oil, to discuss its questionable quality and potential side effects and interactions. If a patient presents with poorly-understood fever, diarrhoea, vomiting or drowsiness, then the side effects of CBD oil should be considered. Finally, CBD should be differentiated from delta-THC, a cannabis-derived chemical with a psychoactive effect, the use of which should be discouraged in children.

Topics: Cannabidiol; Child; Drug-Related Side Effects and Adverse Reactions; Epilepsy; Humans; Netherlands; Pain

Medically refractory epilepsy continues to be a challenge worldwide, and despite an increasing number of medical therapies, approximately 1 in 3 patients continues to have seizures. Cannabidiol (CBD), one of many constituents of the Cannabis sativa or marijuana plant, has received renewed interest in the treatment of epilepsy. While highly purified CBD awaits Food and Drug Administration (FDA) approval, artisanal formulations of CBD are readily available and are seeing increased use in our patient population. Although randomized controlled trials of CBD are ongoing and promising, data regarding artisanal formulations of CBD are minimal and largely anecdotal. Here, we report a retrospective study to define the efficacy of artisanal CBD preparations in children with epilepsy. Given the known interaction between CBD and clobazam, we also conducted a subgroup comparison to determine if clobazam use was related to any beneficial effects of CBD. Additionally, we compared response rates with CBD and with clobazam alone within an overlapping patient cohort. A pediatric cohort with epilepsy of 108 patients was identified through a medical record search for patients using CBD oil. The addition of CBD resulted in 39% of patients having a >50% reduction in seizures, with 10% becoming seizure-free. The responder rate for clobazam was similar. No patients achieved CBD monotherapy, although the weaning of other antiepileptic drugs (AEDs) became possible in 22% of patients. A comparable proportion had AED additions during CBD therapy. With concomitant use of clobazam, 44% of patients had a 50% reduction in seizures upon addition of CBD compared with 33% in the population not taking clobazam; this difference was not statistically significant. The most common reported side effect of CBD was sedation in less than 4% of patients, all of whom were also taking clobazam. Increased alertness and improved verbal interactions were reported in 14% of patients in the CBD group and 8% of patients in the CBD and clobazam group. Benefits were more marked in the CBD alone group, in contrast to the CBD and clobazam group, but this difference was not statistically significant. In summary, these findings support efficacy of artisanal CBD preparations in seizure reduction with few significant side effects. The response to CBD was independent of concurrent clobazam use, although clobazam may contribute to the sedation seen with concurrent CBD use.

Topics: Adolescent; Anticonvulsants; Attention; Cannabidiol; Cannabis; Child; Child, Preschool; Clobazam; Drug Resistant Epilepsy; Drug-Related Side Effects and Adverse Reactions; Epilepsy; Female; Hospitals; Humans; Longitudinal Studies; Male; Retrospective Studies; Seizures; Treatment Outcome; United States; United States Food and Drug Administration