In June 2018, the Food and Drug Administration approved the first Cannabis-derived drug to treat Lennox-Gastaut syndrome and Dravet syndrome, two rare and severe forms of epilepsy.
Known as Epidiolex, the drug contains highly purified CBD and is approved for patients two years and older. While proven to treat severe forms of epilepsy, it is not without side effects. In clinical trials, researchers observed sleepiness, lethargy, elevated liver enzymes, decreased appetite, diarrhea, rash, insomnia, sleep disorder, and infections—all relatively acceptable risks, especially compared to debilitating seizures.
Doctors still do not know precisely how or why CBD is so effective in treating certain medical conditions, but studies continue to show immense potential. With this encouraging development, there is obvious interest in CBD’s medical application, especially for kids.
Keep these six points in mind when considering if CBD is safe for your children.
Pure CBD, which contains no THC and produces no psychoactive effects, has generally been deemed safe and effective by the World Health Organization. Much less is understood about medical marijuana’s effects on children, and researchers have not yet examined THC’s capacity for safely treating severe developmental or behavioral conditions in children in a large clinical setting.
The American Pediatric Association opposes medical marijuana outside the FDA regulatory process, citing harm to adolescent health and development. However, the organization does support the “compassionate use” of THC products for children with debilitating conditions.
Researchers at the Boston Children’s Hospital reviewed a body of medical marijuana studies in the Journal of Developmental and Behavioral Pediatrics and found that “despite a lot of advocacy, at this time the known harms of long-term marijuana administration outweigh any benefits.”
Other studies support these findings. One study published in Frontiers in Pharmacology administered a high dose of cannabinoids containing a ratio of CBD and THC to two children suffering from different forms of seizures. Both children attained full remission using the extract but also presented signs of THC intoxication.
Researchers replaced the treatment with a pure CBD isolate, which reduced intoxication symptoms and kept the seizures in remission after four weeks.
The study concluded that “due to the necessary chronic use of these products and the long half-life of THC, cannabis-derived products can cause intoxication in patients with clinical, cognitive, and motor impairments, with detrimental consequences.”
Clinical evidence so far points more towards the use of pure CBD over THC extract, particularly in children.
The limited, albeit promising, clinical evidence for treating childhood disease with CBD has focused primarily on rare and severe forms of epilepsy. Much less is known about other childhood diseases, though that is slowly changing.
It takes time to conduct clinical trials and formulate evidence-based conclusions. Even the World Health Organization, which recently issued a statement in favor of CBD, did not add CBD to its list of medications considered to be most effective and safe for adults or children.
The American Academy of Pediatrics only recently changed its stance to support the limited use of products to treat life-threatening conditions in children.
Bottom line: if you are wondering if CBD is a good option for your child, consult a doctor.
The limited body of CBD research involving children looks promising, including applications for treating epilepsy, anxiety, nausea, and autism.
The most significant clinical CBD study in the US focuses on Epidiolex’s effectiveness in treating children diagnosed with Dravet syndrome or Lennox-Gastaut syndrome. In three randomized, double-blind, placebo-controlled clinical trials involving 516 patients, including children, pure CBD was effective in reducing the frequency of seizures when compared with placebo.
Another large CBD study included 137 children and young adults suffering from 12 different forms of epilepsy. The study found that almost 50 percent of the patients experienced a decrease in the frequency of seizures with minor side effects.
A 2016 study evaluating the effects of CBD products in treating a ten-year-old girl’s anxiety found that 12 to 25 mg of pure CBD oil daily effectively reduced anxiety and insomnia without harmful side effects. However, the study did not examine long-term effects of CBD in children and was limited to a sample size of one.
In a meta-analysis of 22 studies involving children and adolescents, researchers found evidence for CBD’s ability to mitigate chemotherapy-induced nausea and vomiting, with insufficient evidence for CBD’s effectiveness in treating neuropathic pain, posttraumatic stress disorder, and Tourette syndrome.
Again, these studies lacked long-term follow-ups to evaluate potential side effects and were not designed to be statistically significant.
Israel is currently conducting one of the most extensive clinical trials looking at the link between CBD and autism in 120 children and young adults. The CBD oil contains zero or a low amount of THC, and results will be published at the end of 2018.
A childhood epilepsy study in Australia found no serious adverse side effects in a study of 65 children under the age of 16. Side effects included worsening of pre-existing problem behaviors (12%), possible increase in seizures (12%), drowsiness or lethargy (8%), changes to appetite or weight (6%), gastrointestinal upset (6%), possible intoxication (4%), and temporary changes in sleep and mood (4%).
A similar epileptic study with 137 children found that CBD could effectively treat seizures in 50 percent of the patients, with side effects limited to tiredness (21%), diarrhea (17%), and reduced appetite (16%).
Importantly, many of these studies administered CBD in very high doses, in the range of 25 to 70 mg per day for a child, far beyond a typical dose for most CBD patients. Even at elevated doses, doctors reported few adverse side effects.
CBD is not regulated by the FDA, so it’s a buyer beware market. CBD can range from as little as $5.00 to as much as $60.00 for 100 mg, though a child’s dose would likely be lower.
There is also the issue of purity. Consumer advocates recommend verifying that the product specifically contains CBD, not just “cannabinoids.” If a product does not disclose the amount of CBD, it could contain other cannabis plant parts such as the stem. Also find out how much THC, if any, is in the product before giving it to a child.
Without federal guidelines, dosing should be done under the supervision of a doctor.
CBD is a promising remedy for many conditions ailing adults and children alike—when used appropriately. Select pure, quality CBD products from a reputable dispensary and always consult a doctor for dosing recommendations.
PharmD Scientific Advisor, Medical Reviewer, and Clinical Pharmacist
Adjunct Faculty, UMKC School of Pharmacy
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