Cbd oil for seizures in ct

Epidiolex (Cannabidiol) Primer: Frequently Asked Questions for Patients and Caregivers

On June 25, 2018, the first plant-derived, purified pharmaceutical-grade cannabidiol (CBD) medication, Epidiolex (Greenwich Biosciences Inc, Carlsbad, CA), was approved in the United States by the US Food and Drug Administration (FDA). Epidiolex is for patients 2 years and older with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS), and has revolutionized the treatment of medically refractory seizures in these patients. 1 – 4 The road to widespread therapeutic use of CBD and its recent approval for seizure disorders has been a long one. 1 – 4

Four pivotal randomized, double-blind, multicenter clinical trials evaluated the use of CBD in patients with DS and LGS with regard to the efficacy and safety in convulsive and drop seizure, respectively (GWPCARE 1–4). 4 All trials demonstrated a significant absolute reduction in seizure frequency. 1 – 4 The most common adverse drug effects (≥10%) depicted in the trials included somnolence, fatigue, rash, decreased appetite, diarrhea, insomnia, infection, and elevated transaminases. 1 – 4

Epidiolex is a CBD-only component, with no Δ 9 tetrahydrocannabinol [Δ 9 THC]. 1 THC is the psychoactive component of cannabis, responsible for appetite stimulation and a euphoria sensation. 5 , 6 When referring to cannabis it is a collective term for 3 species of hemp plants, including Cannabis sativa, Cannabis indica, and Cannabis ruderalis. 5 , 6 Both THC and CBD are considered phytocannabinoids, which are chemicals within cannabis that may interact with the cannabinoid receptor. 5 , 6 Although the exact mechanism of action is unknown, both CBD and THC are thought to be efficacious in their role for pediatric epilepsy. 5 , 6 Using the non-psychoactive component, CBD, allows patients to have few side psychoactive side effects while still having the benefit of reduction in seizure frequency. 6 There are other cannabidiol products currently on the market, including hemp oil. Hemp oil is federally legal and contains less than or equal to 0.3% THC and is hemp derived. It can be bought over the counter at pharmacies, grocery stores, and even gas stations. 7 Some states allow patients or caregivers to possess CBD products greater than 5% with a state permit. 7 Although it is becoming increasingly common to see patients on hemp oil because of the ease of access, it is important to recognize that none of these products are FDA approved and have efficacy data in relation to seizures. 7 The FDA has released a statement saying it is “aware that some companies are marketing products containing cannabis and cannabis-derived compounds in ways that violate the Federal Food, Drug and Cosmetic Act (FD&C Act) and that may put the health and safety of consumers at risk.” 8 The Table below contains a list of frequently asked questions regarding Epidiolex.

Table.

Epidiolex (Cannabidiol): Frequently Asked Questions for Patients and Caregivers

Question Response
What is Epidiolex? It is an FDA-approved, plant-derived, purified prescription cannabidiol, indicated for the treatment of seizures in patients 2 years and older. 9
Is a state permit required for Epidiolex? No, it is an FDA-approved prescription medication (Schedule V), making it legal under federal law; therefore, no state permit is necessary.
Are cannabidiol and marijuana the same thing? No, CBD is derived from the cannabis (marijuana) plant; however, it is entirely different from marijuana and has none of the euphoric properties or abuse potential. CBD and THC are the 2 most frequent chemicals found in the plant.
Does Epidiolex contain THC? No. However, other CBD, “hemp,” and medical marijuana products available may contain small amounts of THC. These products are not regulated; therefore, there is variability in how much THC has been removed from these products and how much CBD is in these products.
Are Epidiolex and CBD the same thing? Epidiolex is the brand name for the pharmaceutical-grade cannabidiol oil product produced by Greenwich, whereas other CBD, “hemp,” and medical marijuana products available may contain small amounts of THC. These products are not regulated; hence, there is variability in how much THC has been removed from these products and how much CBD is in these products.
Is it possible to test positive for marijuana while on this drug? While on Epidiolex, patients may test positive on urine drug screenings. Patients/parents should inform the drug testing site that they are taking Epidiolex as prescribed by their doctor.
Will Epidiolex cause my child to have euphoria-like experiences (i.e., the “high”)? No, Epidiolex will not create euphoric effects because it does not contain any THC, which is the chemical compound in marijuana that creates the “high” effect.
Can my child become addicted to Epidiolex? No
How is Epidiolex formulated? Epidiolex comes in a strawberry-flavored, sesame oil–based oral solution.

CBD, cannabidiol; FDA, US Food and Drug Administration; THC, tetrahydrocannabinol

Table.

Epidiolex (Cannabidiol): Frequently Asked Questions for Patients and Caregivers (cont.)

Question Response
If my child is allergic to strawberries or sesame seeds, can they take Epidiolex? Epidiolex can be given to patients with strawberry allergies because it only contains strawberry flavoring. However, as with any allergy, it is important to discuss with your child’s physician first. Epidiolex is not recommended for patients who have a sesame seed allergy because Epidiolex is made in sesame oil.
How should Epidiolex be stored? It should be stored at room temperature and can be used within 12 weeks of opening. It is important to throw away any remaining medication after 12 weeks.
Does Epidiolex interact with my child’s other medications? There is a possibility that Epidiolex may interact with other prescription, non-prescription, and herbal medications that your child may be taking. Please speak to your doctor or pharmacist before starting this medication. You should also make sure they are aware anytime you add a new prescription or non-prescription drug. If you have any questions regarding other medications, talk to your doctor or pharmacist.
How is Epidiolex given? It is given twice daily and is dosed based on your child’s weight. It is important that Epidiolex be given consistently with meals and given around the same time each day.
Can Epidiolex be given with food? Although Epidiolex can be given with or without food, it is preferred that it be given with meals.
Can Epidiolex be administered through a gastrostomy (G-tube)? Yes; however, the G-tube should be flushed well. Give Epidiolex first, followed with water, then give some formula, and follow with water to flush the G-tube well. Please discuss this with your physician. (Greenwich Biosciences Inc., written communication, June 12, 2019).
Is Epidiolex compatible with my child’s ketogenic diet? Yes. It may be given to your child if they are on the ketogenic diet. You should discuss with your doctor, dietitian, or pharmacist about your dietary therapies and any changes before starting Epidiolex.
What are the most common side effects of Epidiolex that my child may experience? The most common reported side effects include drowsiness, diarrhea, decreased appetite, lack of energy, sleep problems, increased liver enzymes, and infections.
Can my child overdose on Epidiolex? As with any medication, overdoses or taking more than prescribed by your child’s doctor can be harmful. If you suspect an overdose, accidental or not, please call your physician or poison control at (800) 222–1222.
Where can I get Epidiolex? Epidiolex is only dispensed through specialty pharmacies. Someone from the pharmacy will verify your child’s prescription and work with your insurance company.
Will medical insurance cover Epidiolex? Yes, most plans do. There is an approval process that can take days to a few weeks. It is approved for patients 2 years and older with a diagnosis of Lennox-Gastaut syndrome or Dravet syndrome.
Is there financial or patient support for Epidiolex? The manufacturer has a support program. “Epidiolex Engage” includes an Epidiolex Copay Savings Program. Talk to your doctor or pharmacist should you have any concerns about affording your medications. https://www.epidiolex.com/engage-patient-support/assistance
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CBD, cannabidiol; FDA, US Food and Drug Administration; THC, tetrahydrocannabinol

Footnotes

Disclosure The authors declare no conflicts or financial interest in any product or service mentioned in the manuscript, including grants, equipment, medications, employment, gifts, and honoraria.

REFERENCES

2. Devinsky O, Cross JH, Laux L et al. Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome (GWPCARE1) N Engl J Med. 2017; 376 (21):2011–2020. [PubMed] [Google Scholar]

3. Devinsky O, Patel AD, Cross JH et al. Effect of cannabidiol on drop seizures in the Lennox-Gastaut syndrome (GWPCARE3) N Engl J Med. 2018; 378 (20):1888–1897. [PubMed] [Google Scholar]

4. 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. 2018; 391 (10125):1085–1096. [PubMed] [Google Scholar]

5. O’Connell BK, Gloss D, Devinsky O. Cannabinoids in treatment-resistant epilepsy: a review. Epilepsy Behav. 2016; 70 (pt B):341–348. [PubMed] [Google Scholar]

6. Campbell CT, Phillips MS, Manasco K. Cannabinoids in Pediatrics. J Pediatr Pharmacol Ther. 2017; 22 (3):176–185. [PMC free article] [PubMed] [Google Scholar]

7. Perucca E. Cannabinoids in the treatment of epilepsy. J Epilepsy Res. 2017; 7 (2):61–76. [PMC free article] [PubMed] [Google Scholar]

8. 2018 Farm bill legalizes hemp, but obstacles to sale of CBD products remain. The National Law Review. 2019 Mar 5; https://www.natlawreview.com/article/2018-farm-bill-legalizes-hemp-obstacles-to-sale-cbd-products-remain Accessed June 19, 2019.

9. FDA Regulation of cannabis and cannabis-derived products, including cannabidiol (CBD) US Food and Drug Administration Web site. https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd Accessed October 12, 2019.

Articles from The Journal of Pediatric Pharmacology and Therapeutics : JPPT are provided here courtesy of Pediatric Pharmacology Advocacy Group

How CBD Can Help Treat Epilepsy

Epidiolex, a CBD-based medication, has been approved by the FDA for the treatment of two severe forms of epilepsy: Dravet and Lennox-Gastaut Syndrome. CBD’s potential anti-seizure properties have made it an emerging therapeutic treatment for people with epilepsy.

Learn how CBD could work as an effective treatment for epilepsy, along with how to use the cannabinoid to manage and reduce seizures.

Download Free Guide to CBD

How CBD Works for Epilepsy

There are several science-backed reasons why CBD seems to work for epilepsy:

    • High concentrations of CBD stabilizes sodium channels, helping regulate the neurons in the brain.
    • CBD seems to work on sodium, potassium and calcium ion channels in particular.
    • Regulating sodium and calcium channels reduces the release of excitatory glutamate. This mechanism is important, as even slight irregularities in the actions of calcium and sodium channels can trigger epileptic seizures. Anticonvulsants that act in such a manner could also be used to treat disorders such as bipolar disorder.
    • CBD acts as an anti-inflammatory as it suppresses damaging inflammatory responses.
    • CBD desensitizes the temperature-regulating receptor, TRPV1 (vanilloid receptor). Those with conditions like neuropathy, rheumatoid arthritis and epilepsy have particularly sensitive TRPV1 receptors. TRPV1 receptors are usually targeted by benzodiazepine-based sedatives, which are addictive and can be a problem of its own. Cannabinoids like CBD are an ideal alternative.

    It is interesting to note that THC also displays significant anticonvulsant properties, as do many other cannabinoids, psychoactive or non-psychoactive. Two of particular note are the CBD-related cannabidivarin (CBDV) and the acidic form of THC, tetrahydrocannabinolic acid (THCA).

    The purity of the product and the dosage matters, too. Most hemp-derived CBD products available on the legal market may be ineffective, and may even make seizures worse. It is also worth noting that the biphasic effects of THC may give it both anticonvulsant and proconvulsant effects, depending on dosage and the amount of THC and CBD there is in the product. Epidiolex contains a high amount of CBD, with very little THC.

    Many products available on the medical marijuana market suitable for epilepsy may contain high CBD:THC ratios of 20:1 and above. Combined low doses of THC and THCA may be beneficial, but too much may be best avoided.

    Effectiveness

    One clinical study revealed that Epidiolex use resulted in a nearly 44% reduction in seizures, compared with not quite 22% for people taking the placebo. These numbers serve as an example of the potential effectiveness of Epidiolex and other CBD-based treatment options for epilepsy in a small population sample. More research is needed to understand how CBD products work for people with epilepsy across a wider population.

    Despite a limited amount of research, epilepsy and seizures more generally is a common qualifying condition for medical marijuana programs throughout the US. This prevalence suggests that there is a general consensus that cannabis is beneficial for people with epilepsy, even if the science has yet to provide conclusive evidence and data.

    Benefits

    There are many reasons why CBD and other cannabinoids may help for epilepsy. Most importantly, the cannabinoid tends to be extremely well-tolerated by the body. Many of the anti-epileptic drugs (AEDs) currently prescribed for hard-to-treat types of epilepsy are benzodiazepine-based, and in some circumstances gabapentinoids, opioids and barbiturates are also used.

    The side effects of benzodiazepines include addiction, drowsiness, confusion, dizziness, “brain fog” and impaired coordination. Such side effects either do not occur with CBD or are extremely mild in comparison.

    What’s worse is that many forms of epilepsy like Dravet Syndrome are actually treatment-resistant, meaning that prescription sedatives may be ineffective for some. This is due to mutations in cytochrome enzymes, which means some people with Dravet may not process sedatives in the same way. Yet, sedatives are sometimes still prescribed, irrespective of an individual patient’s needs.

    Risks and Side Effects

    Just like any other medicine, CBD may have some side effects. These include:

      • Anxiety
      • Changes in appetite
      • Changes in mood
      • Diarrhea
      • Dizziness
      • Drowsiness
      • Dry mouth
      • Nausea
      • Vomiting
      • Some people report high doses of CBD causing a “wiry” or “energetic” effect

      Extreme side effects from CBD are rarely reported, but seek medical help immediately if you experience any reaction that is more than mild.

      Medication Interactions

      Due to how some liver enzymes may process anti-epileptic medications, CBD may negatively interact. If both AEDs and CBD are used at the same time, the AEDs are not metabolized properly and a dangerous amount of benzodiazepines build up in the blood, increasing the chance of overdose.

      Many people who decide to use CBD may need to reduce their intake of AEDs. However, CBD does not necessarily replace all AEDs and some may still need to be used, based upon physician’s advice. Remember that we cannot just stop using benzodiazepines “cold turkey,” as doing so can be dangerous.

      It is for this reason that, for those who are intending to utilize medical cannabis and CBD for seizures, they do so under the supervision of a doctor and develop a program for tapering sedative use slowly and over time, getting an idea of what the “ideal dosage” of CBD and other cannabinoids is for each individual patient.

      Other drug-drug interactions with CBD include:

        • Non-steroidal anti-inflammatory drugs (NSAIDs).
        • Immunomodulators
        • Angiotensin II receptor blockers (ARBs)
        • ACE inhibitors
        • Beta blockers
        • Antiarrhythmics
        • Steroids
        • Antihistamines
        • Antibiotics
        • Anesthetics
        • Antipsychotics
        • Antidepressants
        • Calcium channel blockers
        • HIV antivirals
        • Proton-pump inhibitors

        The above is not a comprehensive list, and not all drugs under the above classes will necessarily have negative effects when combined with CBD. This is because different drugs are metabolized in different pathways. Different cannabinoids are also likely to have different levels of interaction with other drugs.

        How to Use CBD for Epilepsy

        Not all types of epilepsy are the same. Moreover, each person has a unique body chemistry, so what may work for one person may not work for another, or one person may require a different dosage to another. Therefore, the following are general guidelines and not to be interpreted as medical advice.

        Ingestion Methods

        For CBD ingestion methods, tinctures (CBD oil) are most often used, with coconut oil or olive oil being used as the main carrier oil. Epidiolex is a liquid solution that is generally administered orally through a syringe and may be taken with or without food.

        Dosages

        Cannabinoids, including CBD, are biphasic. This means that cannabinoids can have different effects at different dosages. Plus, different people can have radically different reactions to the same cannabinoid taken at the same dosage because every body is different.

        There are other issues with cannabinoids’ biphasic effects. For some people suffering from different types of epilepsy (i.e., not the severe forms of Lennox-Gastaut or Dravet), CBD in too high a dose may not be effective for some kinds of seizures, or in rare instances possibly even make seizures worse.

        Too much THC may increase anxiety in some, and also make seizures feel worse. Another concern is synthetic CBD (and synthetic cannabinoids in general), which can have vastly different pharmacological effects from naturally-derived CBD, and can possibly also increase the likelihood of seizures.

        For at least some people suffering from hard-to-treat forms of epilepsy such as Dravet and Lennox-Gastaut syndrome, CBD:THC ratios such as 18:1 and 20:1 work rather well. Small amounts of THC and THCA may also work in combination with CBD to exert anti-seizure effects and could possibly help make CBD work more effectively.

        Higher doses of CBD and cannabinoids like cannabinol (CBN) may also have sedative effects, which can be beneficial in those with epilepsy. This is because CBN acts as an ideal replacement for benzodiazepines, where its sedative and anti-inflammatory properties are due to its action on vanilloid receptors. Targeting this receptor with cannabinoids instead may help treat seizures and a wide range of conditions (e.g. rheumatoid arthritis) in a far safer manner.

        Frequency

        Epidiolex is usually administered twice daily, but until we have more clinical data, we cannot give precise dosing guidelines for other CBD-based products. However, as some general advice, “slow and low” is a good start. For many types of conditions, two to three doses of CBD-rich, cannabinoid-based tincture per day are used. If using cannabinoid products of any sort, it is important to look at total cannabinoid content and what ratio these are in. Other factors to consider are: