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CBD for epilepsy is FDA approved

CBD is FDA Approved For Epilepsy To Help Children

The US FDA (Food and Drug Administration) has approved cannabidiol (CBD) for epilepsy. Epidiolex, a CBD oral solution is officially supported as an effective treatment method for two rare forms of epilepsy, Dravet syndrome and Lennox-Gastaut syndrome. This treatment has been approved for children 2 years and older.

Epidiolex is making waves as the first FDA approved medicine containing CBD, which is derived from hemp and marijuana.

CBD For Epilepsy

Rare Forms Of Epilepsy: 

  • Dravet syndrome – Also known as Myoclonic Epilepsy of Infancy (SMEI), is a lifelong form of epilepsy that begins during the first year of life. Sufferers experience frequent, prolonged seizures, delayed language and speech issues, growth and nutrition issues, sleeping difficulties, and more. Sufferers require constant care and face a 15 – 20% mortality rate.
  • Lennox-Gastaut syndrome – Occurs in childhood and often begins between the ages of 3 – 5. Most children affected have tonic seizures, where their muscles uncontrollably contract. Also, most of the seizures occur during sleep. Lennox-Gastaut syndrome symptoms include loss of alertness, drop attacks, confusion, intellectual disability, delayed motor skills, and more.

Epidiolex Clinical Trials

“LGS and Dravet syndrome are two of the most severe and difficult-to-treat forms of childhood-onset epilepsy. These children and their families face a long and challenging road and very few achieve adequate seizure control,” said Elizabeth Thiele, M.D., director of the pediatric epilepsy program at Massachusetts General Hospital, professor of neurology at Harvard Medical School and a lead investigator in the EPIDIOLEX clinical program. “Based on numerous clinical trials, this medication may help meet the need for this specific pediatric patient population and is now the first to be approved by the FDA in Dravet syndrome.”

FDA approved clinical trials of CBD for epilepsy Epidiolex is pure plant-derived CBD and was developed with a concentration on severe, early-onset, treatment-resistant epilepsy syndromes. Along with Dravet syndrome and Lennox-Gastaut syndrome, Epidiolex was also developed for the treatment of Tuberous Sclerosis Complex (TSC), and Infantile Spasms (IS).

The FDA provided their due diligence in approving Epidiolex based on a series of accepted clinical trials to obtain safety and effectiveness information. This data was necessary for the FDA as well as regulatory authorities around the world to approve Epidiolex as a prescription medicine.

During the blinded trials, eligible patients were randomly assigned either Epidolex or a placebo in addition to their current treatment. Because the trials were blind, patients, families, and physicians were unaware of who received the treatment as they observed the effects over time.

After 516 patients participated in the trials, it was found that those who received Epidiolex experienced a 50% reduction in seizures compared to those with the placebo.

“For those living with intractable seizures caused by LGS and Dravet syndrome, EPIDIOLEX represents a true medical advancement,” said Philip Gattone, president and CEO of the Epilepsy Foundation.  “Clinical development for these rare and severe conditions is essential, and today’s news brings hope for these patients and their families that a new treatment option may have the potential to help better control their seizures.”

The most common Epidiolex side effects include:

  • Diarrhea
  • Rash
  • Fatigue
  • Insomnia
  • Infections
  • Sleepiness
  • Decreased Appetite
  • Elevated Liver Enzymes

Will Epidiolex Get My Child High?

No. CBD or cannabidiol doesn’t contain any THC, the psychoactive cannabinoid found in marijuana. Therefore, it doesn’t have any mind-altering effects. Due to being derived from marijuana there is some controversy around it, even though CBD has a high potential to alleviate pain, stress, insomnia, and more.

From CBD oil, edibles, infused beverages, supplements, topical creams, and more there are a large variety of products on the market that are legally sold in most states.

The Future of CBD

CBD for epilepsy probably wont be the last FDA approved use While Epidiolex may be paving the way for future FDA approved CBD products, many items on the market right now are unregulated. With proper testing, CBD will likely be approved for more medical treatments in the future, in the meantime, the FDA will continue cracking down on non regulated CBD products.

CBD oils and other items have different dosages and health claims, so even though CBD has the potential to provide relief for a variety of ailments do proper research before purchasing any products.

Make sure that the CBD is derived from a reputable source by:  

  • Checking if the hemp or marijuana the CBD is derived from is grown in the US.
  • Seeing if the CBD is derived from the whole plant or part of the plant. The whole plant provides higher quality CBD oil.
  • Referring to how much THC is in the CBD. It should not exceed 0.3%.
  • Viewing recent lab studies as reputable brands should have recent results available.
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