cbd and childrenDecember 15, 2021
Anecdotally, many parents have reported that CBD oil is beneficial for their children. However, when it comes to your child, take a buyer-beware approach. Always talk to your child’s pediatrician before starting any new supplements or medications. Speak to a cannabis specialist to get specific advice on cannabinoids, doses, and product types that will benefit your child’s condition.
CBD, short for cannabidiol, is a product that’s derived from cannabis. It’s a type of cannabinoid, which are the chemicals naturally found in marijuana plants. Even though it comes from marijuana plants, CBD doesn’t create a “high” effect or any form of intoxication that is caused by another cannabinoid, known as THC.
(U.S. Food & Drug Administration)
What are the Risks of Using CBD Oil for Children?
Whelan, Corey. “Should You Use CBD for Children?”
Talk to your doctor before using CBD oil. It hasn’t been approved by the U.S. Food and Drug Administration (FDA) for any medical uses, and it can have side effects.
Furthermore, with the added attention, more studies are looking at the potential effects and benefits CBD and marijuana may hold for pets. Many veterinarians are recommending CBD oils and extract treats for animals with certain conditions, and the popularity of this growing trend doesn’t seem to be slowing down any time soon.
It may also interact with other medications your child is taking. Much like grapefruit, CBD interferes with some of the enzymes needed to metabolize drugs in the system. Don’t give CBD to your child if they are taking any medication that has a grapefruit warning.
CBD pet care products come in many of the same forms, you are probably used to seeing for humans, including edibles (think: chewable treats and capsules), oils that can be added to food or placed under the tongue and topical creams or balms that are rubbed directly on the skin. Like the CBD products meant for humans, each of these CBD pet care product types appears to have a different effect on the body, in dogs, anyway.
For hundreds of years, people have used marijuana. But CBD oil use is a relatively new idea. No longitudinal studies can still confirm the result for the use in children or their effects. It may produce significant side effects, such as restlessness and issues with sleep that may be like the conditions you are trying to treat.
We strongly recommend that people interested in CBD should seek out a doctor who understands about the extract and its potential uses. They need to be monitored and managed by cannabis specialists. Individual treatment or for pets, people should not just go out and buy CBD extract thinking it as a sure shot remedy for any ailment.
What is CBD Oil In Simple Terms?
Unfortunately, there are many unanswered questions about the effects of marijuana and CBD in pets. But research into these effects is underway. Studies are underway to look at the potential benefits of CBD for controlling pain from conditions such as osteoarthritis, calming anxious pets, and if it may help with treating epilepsy in dogs.
CBD oil is unregulated, making it difficult, if not impossible, for parents to have complete confidence about what’s in the product they’re purchasing. A study published in JAMA (Journal of American Medical Association) revealed labeling inaccuracies among CBD products. Some products had less CBD than stated, while others had more.
CBD oil is available in a wide range of forms, like baked goods and beverages. It becomes harder to know the exact quantity of CBD in those products. Other than using prescription products like Epidiolex, it’s difficult, if not impossible, to control the amount of CBD administered to any child using these products.
“ Cannabis (Marijuana) and Cannabinoids: What You Need To Know. ” Edited by Health Information, National Center for Complementary and Integrative Health , U.S. Department of Health and Human Services, Nov. 2019, www.nccih.nih.gov/health/cannabis-marijuana-and-cannabinoids-what-you-need-to-know.
A lot of companies manufacture CBD oil today. However, it is not federally regulated so it is hard to know whether a product is safe and providing an accurate dose. CBD oil can sometimes contain THC and other toxins.
Key Facts About Products Containing Cannabis or CBD:
Commissioner, Office of the. “What to Know About Products Containing Cannabis and CBD.” U.S. Food and Drug Administration , FDA, 3 May 2020, www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis.
Cherney, Kristeen. “CBD Oil Benefits: Cancer, Pain, Anxiety, and More.”
There are some mixed opinions around cannabis products like CBD oil because of recreational marijuana use. But there’s growing awareness about the possible health benefits of CBD oil.
Healthline , Healthline Media, 7 Apr. 2020,
Cannabidiol (CBD) oil is one of the most discussed products in states that have legalized medical marijuana. And people often use the words’ cannabis’ and ‘marijuana’ interchangeably, but they don’t mean the same thing.
Kosecki, Danielle. “Should You Give Your Pets CBD? It Depends.”
A group of Israeli researchers have been exploring the use of CBD to reduce problem behaviors in children on the autism spectrum. A feasibility study involving 60 children found substantial improvement in behavioral outbreaks, anxiety and communication problems, as well as stress levels reported by parents.
The “preclinical” evidence (ie from animal studies) “conclusively demonstrates CBD’s efficacy in reducing anxiety behaviors relevant to multiple disorders,” Dr. Blessing wrote. Those include generalized anxiety disorder, PTSD, panic disorder, social anxiety disorder and OCD.
For millennia, hemp plants have been used for medicinal purposes around the world. In 1851 marijuana was classified by the United States Pharmocopeia as a viable medical compound used to treat conditions like epilepsy, migraines and pain. But since marijuana and cannabis-related products were made illegal in the US in 1970, there has been a dearth of research about either marijuana or CBD. Its classification as a Schedule 1 drug made it nearly impossible to get federal funding to study cannabis.
Not only are adults experimenting with CBD for whatever is bothering them, increasingly parents are turning to CBD to help their kids focus, sleep, calm down and more.
“The biggest problem is there’s a lot that we still need to know, especially in kids,” says Paul Mitrani, MD, a clinical psychiatrist at the Child Mind Institute. “In regards to treating mental health disorders in children and adolescents, there’s a lack of evidence to support its use.”
CBD and autism.
Last year the World Health Organization, acknowledging the explosion in “unsanctioned” medical uses of CBD, reviewed the evidence for its safety and effectiveness. The WHO report concluded that “CBD is generally well tolerated with a good safety profile.” Any adverse effects could be a result of interactions between CBD and a patient’s existing medications, the WHO noted.
But popular use of CBD is blowing up with very little research into its safety or its efficacy, especially in children. The first and only marijuana-derived drug approved by the Food and Drug Administration, Epidiolex, is used to treat a rare, severe form of epilepsy in patients two years of age and older. And since cannabis is in the early stages of legalization and regulation, there is a huge variety in the quality and dosage of products — risks associated with using products that have not been vetted by the FDA.
Available in the form of vaping, oils, lotions, cocktails, coffee, gummies — you name it — CBD has been touted as a treatment for complaints as far-reaching as chronic pain, cancer, migraines, anxiety and ADHD. You know it’s gone mainstream when even Consumer Reports has issued guides on how to shop for CBD and tips for safe CBD use.
Although a few studies have found that CBD oil might work for anxiety, they only looked at healthy people who were put in situations that made them anxious. There are no studies yet on people with chronic anxiety. Researchers are also exploring CBD for kids with autism spectrum disorder. The results are good so far, but more research needs to be done before we can know if it’s safe and effective.
The report found no indication of potential abuse or dependence. “To date there is no evidence of recreational use of CBD or any public health-related problems associated with the use of pure CBD.”
Since there isn’t a lot of research about CBD, doctors say there are some risks with using CBD for kids. For example, CBD products may contain things other than CBD, and those things could be harmful. Plus, we don’t yet know if CBD works well with other medications or how much you should give your child.
In the US, research has been given a boost by changing guidelines and laws. In 2015 the DEA eased some of the regulatory requirements that have made CBD, as a Schedule 1 substance, difficult to study. “Because CBD contains less than 1 percent THC and has shown some potential medicinal value, there is great interest in studying it for medical applications,” the DEA said in announcing the change.
Though CBD — full name cannabidiol — is extracted from marijuana or hemp, it doesn’t contain THC, the chemical in marijuana that has psychoactive effects, so it doesn’t make you feel high.
CBD is everywhere. From corner stores and bars to medical marijuana dispensaries, it’s being offered for its reputed ability to relieve pain and make people feel better.
In 2015 a group of researchers led by Esther Blessing, PhD, of New York University, investigated the potential of CBD for treating anxiety. In a review of 49 studies, they found promising results and the need for more study.
CBD oil for anxiety.
And in approving the first CBD-based drug, Epidiolex, last year the FDA expressed enthusiasm for the research boom that is sure to come, paired with stern words for the flood of marketers of products claiming unsubstantiated health benefits.
Because CBD is so new, there also aren’t a lot of rules about what can and cannot be included in CBD products. So, there’s a huge variety in the quality of products. You may even find different amounts of CBD in different packages of the same product.
While anecdotal evidence of the benefits of CBD is common, there are risks associated with using these products, especially in children. Some of the concerns:
Dr. Mitrani, who is a pediatrician and child and adolescent psychiatrist, says it’s an area worthy of investigation but recommends that parents wait until further research is done before giving a child CBD.
As for effectiveness, the WHO noted that several clinical trials had shown effectiveness for epilepsy, adding: “There is also preliminary evidence that CBD may be a useful treatment for a number of other medical conditions.”
“Overall, current evidence indicates CBD has considerable potential as a treatment for multiple anxiety disorders,” Dr. Blessing concludes, “with need for further study of chronic and therapeutic effects in relevant clinical populations.”
CBD is still pretty new, so there’s very little research about its safety or how well it works, especially for children. So far, there’s only one marijuana-derived medication that has been approved by the Food and Drug Administration. It’s called Epidiolex, and it’s used to treat a rare form of epilepsy in patients who are at least two years old.
Concerns about CBD.
These days, you can find CBD everywhere. Some people believe that it can treat everything from chronic pain and cancer to anxiety and ADHD. But is it safe for kids?
The review notes that the promising preclinical results are also supported by human experimental findings, which also suggest “minimal sedative effects, and an excellent safety profile.” But these findings are based on putting healthy subjects in anxiety-producing situations and measuring the impact of CBD on the anxiety response. Further studies are required to establish treatment with CBD would have similar effects for those who struggle with chronic anxiety, as well as what the impact of extended CBD use may be.
The researchers, led by Adi Aran, MD, director of the pediatric neurology unit at Shaare Tzedek Medical Center, went on to do a double-blind, randomized, placebo-controlled trial with 150 participants with autism. In this trial, just completed but not yet analyzed, patients were treated CBD for three months.
“We’ll continue to support rigorous scientific research on the potential medical uses of marijuana-derived products and work with product developers who are interested in bringing patients safe and effective, high quality products,” the FDA pledged. “But, at the same time, we are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims.”
Over the past several years, medical marijuana use has become a controversial topic not only within the medical community but also at state and national legislative levels. Although marijuana and its derivatives are currently Schedule 1 substances per the federal Controlled Substances Act (CSA), many states have relaxed their legislation to allow use. More recently, the use of cannabidiol (CBD) products in pediatrics has sparked additional debate, and pediatric providers have started encountering patients experimenting with these products in their daily practice, necessitating an understanding of the history and available medical literature on this topic.
Worldwide, marijuana is the most commonly abused illegal substance and adolescent daily use is on the rise. 18 Adolescents perceive that marijuana use is not as much of a risk owing to legalization and decriminalization, leading to its use both recreationally and to self-treat anxiety and other psychiatric conditions. Unfortunately, the neurocognitive and behavioral effects of marijuana use in pediatric patients, including its effects on psychological dysfunction, amotivation syndrome, and carcinogenic risk, have been widely reported. 4 , 21.
In the 1930s, political propaganda sought to associate marijuana use, specifically by minority and low-income populations, with psychosis, addiction, and violent crime. Many believe this was influenced by several prominent businessmen in competing synthetic fiber industries in attempts to reduce the size of the growing hemp industry. 5 Marijuana soon became labeled as a drug of abuse and to discourage its use, Congress passed the Marijuana Tax Act of 1937 placing a heavy tax on cannabis and hemp use for both medicinal and industrial purposes. Despite opposition from the American Medical Association (AMA) and physicians who believed in the medical efficacy of marijuana, by 1941, all cannabis preparations were removed from the USP and National Formulary.
Pharmacists are also poised to participate in the design and evaluation of current and future research in this area. The importance of drug interactions between CBD and other antiepileptics remains uncertain both for the efficacy and safety of CBD products. The difference in concentrations, dosages, and formulations of various products sold at private dispensaries is not standardized or regulated. Differences in state legislation on allowable concentrations and amounts can be confusing for patients and their families, and pharmacists can help to provide that information. Various organizations have been helpful in updating and summarizing this information. 9.
The debate about the use of cannabinoid products in pediatric patients has persisted owing to the lack of well-developed and published randomized controlled trials. There has been a wide variety of mostly case series and international studies for adult indications, such as chronic pain, MS, headache, and various neuropsychiatric disorders, which are beyond the scope of this review but have been reviewed elsewhere. 20 The pediatric literature lacks the same breadth owing to public stigma and restrictions on investigational use. This has resulted in retrospective and parentally reported data in epilepsy and behavioral conditions. Despite the overall lack of published data on CBD in pediatric patients, most of the literature is devoted to its use in epilepsy. Current large prospective trials are underway for different epilepsy indications, and recent animal studies researching use in perinatal brain injury and neuroblastoma may open new avenues to consider cannabinoids for pediatrics.
Investigators at Stanford University administered a survey to 150 parents on Facebook to identify parentally reported effects of CBD on their child’s seizures. 32 Of 19 respondents aged 2 to 16 years, 18 had treatment-resistant epilepsy for more than 3 years before CBD use. Based on parental response, 84% reported a reduction in child’s seizure frequency with 50% having a greater than 80% reduction in seizure frequency. Twelve of these 19 patients were also able to be weaned from another antiepileptic drug. In addition, parents reported overall better mood, increased alertness, and better sleep. Parents reported oral CBD dosages of 0.5 mg/kg/day to 28.6 mg/kg/day and THC of 0 to 0.8 mg/kg/day.
Several other synthetic forms of cannabinoids have been available for use in some countries, including dronabinol, nabilone, and nabiximols ( Table 2 ). These products are being used to treat nausea and vomiting associated with chemotherapy, anorexia and weight loss in patients with acquired immune deficiency syndrome (AIDS), and relief of spasticity and neuropathic pain associated with multiple sclerosis (MS). 13–16 Epidiolex (GW Pharmaceuticals, Cambridge, United Kingdom) is a CBD product currently in clinical trials. 17.
Many health care facilities are working through processes that address patient use of these medications. Because use of cannabis products outside of approved clinical trials is not legal under federal law, thus not permitted under Centers for Medicare & Medicaid Services (CMS) Conditions of Participation, there are significant challenges in managing hospitalized patients. Whatever the state and situation, pharmacists need to be aware of the external factors associated with allowing a patient to use CBD in an inpatient setting.
In the 1960s and early 1970s, marijuana soon became associated with recreational use by anti-establishment groups further adding to the stigma associated with its usage. By 1970, the CSA labeled cannabis as a Schedule 1 substance. This relatively short era of recreational marijuana use has influenced how the public perceives the drug. Since that time, there have been repeated unsuccessful attempts to reconsider its Schedule 1 status to allow for easier investigation. 5 The AMA and the American Academy of Pediatrics (AAP) have reaffirmed their opposition to the legalization of medical and recreational marijuana use outside of any US Food and Drug Administration (FDA) regulatory process. 7.
What’s The Harm?
In addition to increased emergency room visits, from 2005 to 2011, the call volume at Poison Control Centers for pediatric marijuana exposures had increased by 30.3% in states where marijuana has been decriminalized as compared to a steady rate in states that have not adopted marijuana decriminalization legislation. 49 While marijuana and CBD products are becoming more available, these products remain in DEA (Drug Enforcement Administration) Schedule 1 status and are therefore not regulated in manufacturing, packaging, and labeling outside of clinical trials. As seen in the Colorado case study, 50% of the unintentional ingestions were secondary to an edible, which children can easily mistake for food if not supervised by parents. None of these products are required to have safety packaging to prevent accidental ingestion by children. In addition, no warning labels or verification of product ingredients is required, leaving the medical community caught between providing safe medical care and allowing patient autonomy. As mentioned previously, the AAP has published recommendations to limit the access of marijuana to children.
Many of the misconceptions regarding medical marijuana in the pediatric population stem from negative connotations associated with the term marijuana owing to its psychoactive effects. Therefore, it is important to define the various terms associated with products that are currently being used by the public as well as by pediatric researchers. Cannabis is a general term that refers to the 3 species of hemp plants ( Cannabis sativa , Cannabis indica , Cannabis ruderalis ). 1 Marijuana is a term that describes the dried leaves, flowers, stems, and seeds from the hemp plant that are often smoked for recreational and medicinal use. Marijuana contains various different chemicals called cannabinoids . Cannabinoids are the chemicals found within cannabis that interact with specific receptors, namely, cannabinoid (CB) receptors, within the body. The over 60 types of cannabinoids currently identified differ by the degree to which they are psychoactive. 2 While delta-9-tetrahydrocannabinol (THC), the cannabinoid most commonly associated with marijuana as a drug of abuse, is psychoactive, other cannabinoids including CBD are not. THC has been linked to the development of schizophrenia, and a contributor to neurodevelopment deficits in adolescents. 3 , 4 Different marijuana strains will have varying amounts of both THC and CBD, and thus the concentrations and ratios of these different cannabinoids within a product, especially for pediatric use, has been a subject of interest not only for medical professionals but also for state legislators as well.
The AAP also supports further research into the indications and correct dosage for cannabinoids in addition to developing policy around how to verify purity and formulations. 8 In the meantime, the AAP has suggested good practices to follow when considering the use of marijuana, recreationally or medically ( Table 1 ).
In a similar Facebook survey administered by researchers at the University of California, Los Angeles, the authors 33 similarly reported an 85% reduction in seizure frequency among 117 respondents, with an average age of 6 years. Most patients (86%) conveyed that changes in frequency occurred within 14 days. As with previous surveys, dosage and formulations were varied but based on parental report of formulation used. Overall, most parents (83.5%) reported using an oral CBD product with at least a 15:1 ratio of CBD to THC. Of the 40% of respondents who provided dosages, the median weight-based dose of CBD was 4.3 mg/kg/day given in 2 to 3 oral doses. As mentioned above, these surveys should be evaluated carefully given the inability to verify dose, formulation, and response. The conclusion that can be made is that there is a rather strong positive parental perception regarding the efficacy of cannabinoids, specifically CBD.
History and Regulation.
Historically, patients and recreational users have inhaled or vaporized marijuana, resulting in a quick onset and higher peak concentrations. Owing to first-pass metabolism, the enteral route decreases the bioavailability of THC to from 5% to 20% and CBD to from 6% to 19% and increases the time to onset. 3 , 18 , 19 Differences in absorption between various age groups, populations, and individual people make it difficult to recommend a one-size-fits-all dosage strategy. Interpatient variability may affect which blood concentrations will be effective, and tolerance is known to occur owing to downregulation of CB1 receptors. 3 , 18.
Additionally, endocannabinoids N-arachidonoylethanolamine (anandamide) and 2-arachidonoylglycerol, both arachidonic acid derivatives, bind with CB1 and CB2. While the function of these endogenous ligands is not fully understood, their action may be attributed as antiemetic, antianalgesic, and anti-inflammatory. Endocannabinoids can also play a role in excitation of the neuronal networks, thus having effect on the quality of a seizure. Previous studies have documented deficiencies in endocannabinoids in temporal lobe epilepsy patients as well as a rise in anandamide concentrations post seizures in mice, suggesting an antiseizure activity profile. 6.
The 2 most studied exogenous cannabinoids include THC and CBD. THC is a partial agonist at both CB1 and CB2 receptors and achieves its psychoactive properties likely through modulation of gamma-aminobutyric acid (GABA) and glutamine. THC seems to possess antiseizure activity but may be a proconvulsant in certain species. 12 CBD, however, does not appear to bind to either CB1 or CB2 but does possess neuroprotective and anti-inflammatory effects. 5 Several possible mechanisms of CBD have been proposed: inhibition of cyclooxygenase and lipoxygenase, inverse agonism at CB1/CB2 receptors, and enhancement of anandamide. 3 It is proposed that CBD may be effective in epilepsy through modulation of the endocannabinoid system. CBD halts the degradation of the endocannabinoid anandamide, which may have a role in inhibiting seizures. Additionally, research demonstrates that CBD may play a role with the regulation of T-type calcium channels and nuclear peroxisome proliferator-activated receptor-γ, both of which have been implicated in seizure activity. 12 Because CBD is one of the most abundant cannabinoids within cannabis resin and its mechanism is still unclear, there is peaked interest in the possible clinical indications that it could treat including epilepsy, pain, and inflammatory disorders.
Both THC and CBD are highly lipophilic with long half-lives, 30 hours versus 9 to 32 hours, respectively. 3 , 18 , 20 CBD is also highly protein bound and is both metabolized by and a potent inhibitor of the CYP450 enzymes (2C19, 3A4), potentially causing significant medication interactions. 3 , 18 , 20 , 21 While CYP inducers such as phenytoin and carbamezapine may decrease CBD concentrations, CBD is known to increase concentrations of clobazam, an antiepileptic drug approved by the FDA in 2011 for the treatment of Lennox-Gastaut syndrome (LGS). CBD inhibits CYP3A4 and CYP2C19, preventing the degradation of clobazam and its active metabolite, N-desmethylclobazam. In an expanded access trial, patients with concomitant clobazam and CBD use had increases in clobazam concentrations of > 60% and N-desmethylclobazam, of 500%. 22 At this time it is not clear what other drug interactions may exist and what dosage manipulations may be necessary.
Most orphan drug designations for CBD are for pediatric seizure disorders ( Table 4 ). 34 A search of ClinicalTrials.gov in November 2016 identified 4 completed Phase 2 and Phase 3 protocols for pediatric seizure disorders, as well as 14 ongoing treatment trials, including intermediate-size expanded access protocols (up to 50 patients each). Published findings from open-label use of CBD for treatment-resistant epilepsy under an expanded-access program at 11 epilepsy centers in the United States suggest that CBD might reduce seizure frequency and might have an adequate safety profile in children and young adults with this condition. 35 Congressional testimony in June 2015 indicated that 20 intermediate-size expanded access Investigational New Drug Applications had been authorized to treat approximately 420 children with 1 CBD product; most of these are not listed on ClinicalTrials.gov. 36.