How the only FDA-approved cannabis drug is helping kids
As more adults find relief with medical cannabis, some parents are wondering how CBD may help their kids. Forty-six percent of parents lack knowledge of CBD, according to a national survey conducted by C.S. Mott Children’s Hospital for the University of Michigan Health. A national sample of 1,992 parents of children aged 3-18 were surveyed exclusively for the hospital by Ipsos Public Affairs, LLC, and a majority of respondents agree that the FDA should regulate CBD for kids. Almost a third of those surveyed have talked to their child’s healthcare provider about CBD.
The FDA approved cannabinoid-derived Epidiolex to treat seizures associated with Dravet Syndrome and Lennox-Gastaut in patients two and older. It was not only the first FDA-approved drug that contained cannabis—it was the first FDA-approved treatment for Dravet. Since then, the FDA has approved the drug for treating seizures resulting from tuberous sclerosis complex (TSC). As the FDA approves this cannabinoid-derived treatment for children as young as one, many parents are considering the impact of CBD treatments for kids.
The basics of Epidiolex
According to the survey, the most common reasons parents sought out cannabis treatments for their children were anxiety, sleep problems, ADHD, muscle pain, autism, and to promote general well-being. These results show that many parents have considered CBD for various conditions, and some have already shared positive stories regarding Epidiolex for seizures related to rare neurological diseases.
In the approval announcement, the FDA shared that Epidiolex underwent three randomized, placebo-controlled clinical trials with 516 patients diagnosed with either Dravet or Lennox-Gastaut. The drug effectively reduced seizure frequency as compared to the placebo. Common side effects like lethargy, elevated liver enzymes, and diarrhea were fairly widespread.
What is Epidiolex used for?
Symptoms of Dravet Syndrome present in the first year of life with severe and frequent febrile seizures (seizures brought on by a raised temperature) as well as developmental delay, speech impairment, ataxia, hypotonia, sleep disturbances, and other health issues.
The first sign of Dravet in children is typically seizures lasting more than five minutes and up to thirty minutes. Developmental delays and abnormal EEGs come into play in the second and third years of life. Compared to other epilepsy patients, Dravet patients have the highest Sudden Unexpected Death in Epilepsy (SUDEP)—Most deaths occur in childhood.
The other forms of epilepsy that qualify children for Epidiolex are Lennox-Gastaut and TSC. Lennox-Gastaut is a severe form of epilepsy that can cause up to five types of seizures that usually begin before a child turns four. Most people living with the syndrome experience impaired intellectual function, developmental delays, and behavioral disturbances. The worst risk of the syndrome is damage related to falls from unexpected seizures.
Lennox-Gastaut is difficult to treat, and in 30-35 percent of patients, no cause can be found. Anticonvulsant medicines are the other treatment options for seizures related to the syndrome.
TSC is a rare genetic disorder and often causes intractable epilepsy, meaning antiepileptic drugs have no effect. One in 6000 people have TSC and one-third of patients inherit the disorder from a parent. The other two-thirds of patients develop TSC spontaneously.
TSC first presents as infantile seizures that can last for mere seconds. Patients may also experience growths in the heart, abnormal brain tissue, autism, renal cysts, patches of abnormal color and texture on the skin, and other symptoms.
Treatment for TSC includes trying antiepileptic drugs, dietary changes, neuromodulation, immunosuppressant drugs, and epilepsy surgery. With early diagnosis, most TSC patients have average life expectancies, at least half of patients will have a learning disability, and one-third have a severely impacted IQ.
Proof of concept: children treated by CBD
Dr. Annabelle Manalo Morgan is vocal about how cannabis treatment helped her son in her book Mighty Flower: How Cannabis Saved My Son. At two days old, Dr. Morgan’s son started having seizures. At one point, he experienced up to 200 seizures per day. The family decided on surgery, which removed around 38 percent of the child’s brain–after which he would need multiple medications for the remainder of his life.
Dr. Morgan, who has a B.S. in Biology, a Graduate degree in Neuroscience, and a Ph.D. in Cell and Developmental Biology, decided to take her son off of all medications–instead using CBD as an alternative. After careful research, she made her own pure CBD oil and started distributing it through her son’s gastronomy tube (g-tube).
According to her personal testimony, in only three days, he began expressing emotion and showing greater energy levels. After fourteen months, he started walking, and from then on, he began catching up with other milestones. Now Dr. Morgan’s child is living an average, healthy life.
Possible side effects and safety considerations
Despite positive testimony like Dr. Morgan’s and promising clinical research, some studies show possible side effects of CBD treatment–the most common being dry mouth, diarrhea, change in appetite, and lethargy.
One study compared the results of artisanal versus pharmaceutical CBD products in treating seizures in patients with a median age of 10.1 years. Artisanal CBD products aren’t regulated or standardized by the FDA, meaning some may contain THC and other cannabinoids along with CBD. Results showed patients prescribed artisanal CBD tinctures showed a 70% increase in seizures, while pharmaceutical-grade CBD patients saw a 39% reduction in seizures. Findings suggest that CBD for kids must be pharmaceutical grade to reduce seizures in epilepsy patients.
A review of clinical data and animal CBD trials concludes that more research is needed around the toxicological parameters of the cannabinoid before we can understand the effects of CBD treatment. The review cites a lack of understanding of the long-term effects of chronic CBD administration and how the cannabinoid affects hormones specifically. Before making conclusions, researchers call for more clinical trials with more participants studying CBD safety and side effects.
Anecdotal evidence and mounting studies support the theory that pharmaceutical-grade CBD treatments could treat seizures in rare epilepsy syndromes like Dravet. But parents and advocates urge researchers to continue uncovering the positives and negatives of CBD for kids.
EDITOR’S NOTE: This article has been updated to clarify details of the C.S. Mott Children’s Hospital survey.