Any parent who has tried in vain to soothe a child suffering from a painful ear infection or comfort a teething baby knows that feeling of… Acute arterial ischemic stroke affects 4 over 1000 live newborns. Fortunately CBD can help! Read more in our new article: CBD for newborn babies When Waldo Dwyer was diagnosed with eye cancer at 6 months old, the chemo wreaked havoc on his body. His parents turned to CBD oil.
Joint Warning Letter Targets CBD Claims Relating To Infant and Child Uses
Blog Cannabis Law Update
Any parent who has tried in vain to soothe a child suffering from a painful ear infection or comfort a teething baby knows that feeling of desperation when you may be willing to try just about anything to get the crying to stop. Both yours and the child’s…
It is just this issue that appears to have caught the attention of the FDA and FTC as the target for their most recent CBD enforcement. Similar to the three CBD companies previously targeted, Rooted Apothecary made allegedly unsubstantiated claims that its products could prevent, diagnose, treat, or cure serious diseases. Particularly concerning this time, however, was the fact that some of the claims targeted use on infants and children.
Some examples of the company’s claims included the following:
- “Instead of synthetic chemical[s] that can have safety concerns, this blend uses the best of nature to help calm the inflammation and pain of teething, while also promoting sleepiness for your little one.”
- “No matter what age, ear aches are a terrible, no good way to live each day! Our main priority was safety, effectiveness . . . as we formulated this for the entire family including our precious little ones. When the pain is bad, this roller goes to work for soothing pain, inflammation, and to battle against the bacterial/viral critters to blame.”
- “Increasing evidence suggests that CBD oil is a powerful option for pain . . . anxiety . . . and autism . . . It seems like an attractive and safe option for children.”
- “[P]ossible uses for CBD include helping with skin problems such as acne, autism, ADHD, and even cancer. It’s often used in conjunction with traditional treatments to provide extra help. Children can use high amounts of CBD safely and without any risk.”
Once again, CBD marketers should take a lesson from the rules that apply to conventional products, and not just as to claim substantiation. Product claims that target vulnerable populations, such as infants, children, or the elderly, are likely to receive greater scrutiny regardless of the product type. These populations (along with sleep-deprived parents of young children) may be more susceptible to believing outrageous claims and less likely or able to articulate it if a product is not working or is potentially causing harm. And that – more than the ear infection – is reason for concern.
CBD for newborn babies
The incidence is even higher in pre-term newborns, affecting approximately 60% of the babies, leading to long-lasting complications of the disease.
Around one third of the newborns affected by stroke develop unilateral cerebral palsy (which usually impairs use of one hand), and learning and cognitive deficits are also frequent. (1,2)
The manifestation of brain injury differs depending on the maturational status of the brain at the time of the insult. In pre-term babies white matter injury is predominant, being more vulnerable to glutamate toxicity and neuroinflammation as some brain cell populations are still developing.
In contrast, in term babies, in which the maturation of the white matter is more advanced, neuronal degeneration in grey matter structures is the most commonly observed manifestation of injury (3,4).
Cannabinoids to the rescue
So far, hypothermia (applied as head or whole-body cooling) is the only clinical intervention used in hypoxic-ischemic newborn babies. However, hypothermia does not prevent injury in all cases and, the treatment does not always lead to complete functional recovery (14).
Currently, no other treatment is available to patients.
Cannabinoids affect multiple endogenous processes involved in brain injury and recovery. Cannabinoids are also known to control the cell cycle and the proliferation, survival and differentiation of neural stem cells (fundamental for new births, as we have already described in a previous article titled “Endocannabinoids: co-creator of life? Their role from conception to breast-feeding”), capabilities that target them as interesting experimental drugs for the enhancement of endogenous brain repair responses to perinatal brain injury. (5,6)
Cannabinoids modulate neuronal excitability and counteract glutamate excitotoxicity, as we have explained further in a video on Cannabis for ALS.
Moreover, through the activation of CB2 receptors in immune cells cannabinoids can modulate the intensity and extension of neuroinflammatory responses to injury, which we have been extensively describing in: “Caution: understanding the Endocannabinoid System might change your life!”
Finally, cannabinoids have been shown to decrease vascular reactivity (increased blood flow in response to ischemia), overall reducing the rolling and adhesion of circulating leukocytes and preventing their infiltration into the inflamed brain, which is key for a number of disorders, from ischemia to Multiple Sclerosis. (7)
To put these concepts onto test:
in-vitro experiments have been carried out with a synthetic cannabinoid (WIN-55) in an animal model of acute hypoxic-ischemic strokes.
Pre-incubation of the brain slices with WIN (50 mM) prevented glutamate release (neurotoxic), TNFα accumulation and iNOS induction (pro-inflammatory markers), resulting in a reduction of cell death. (8)
This has been further examined in in-vivo studies which administered WIN (1 mg/kg) immediately after hypoxia-ischemia event, resulting in reduced diffusion of injury around brain areas. (9)
CBD as a treatment
It has been demonstrated that CBD has neuroprotective effects in models of acute hypoxic-ischemic brain damage in newborn animals as well as in adult rodent stroke models.
CBD (1 mg/kg) was shown to induce a sustained reduction in excitotoxic damage, oxidative stress and inflammation up to 7 days after injury, addressing the three major pathophysiological mechanisms involved in the generation of permanent brain damage after arterial ischemic strokes. (10)
In a more recent study, an animal model of severe stroke in newborn rats, CBD (5mg/kg) was administered post-insult, overall reducing peri-infarct brain-damage and restoring neurobehavioural function in the short and long term.
The volume of the infarct was not modified by CBD, but its beneficial effects were apparent already one week after the stroke, including prevention of long-lasting functional impairment, while no side effects of the drug were observed.
Following CBD administration, movement impairment was restored, it improved neurobehavioural functions controlling strength, coordination and sensorimotor performance , as well as other cognitive deficits, whilst further neuronal loss was prevented. (11)
Cannabidiol to newborns
The prospects of cannabidiol (CBD) becoming effective and safe therapeutic drug against neonatal hypoxia-ischemia increased considerably after several studies demonstrated the beneficial effects of CBD on multiple neurophysiological parameters commonly used for the bedside monitoring of asphyxiated newborns.
In one of those studies the intravenous administration of CBD (0.1 mg/kg) improved brain tissue oxygenation during the first 3 h after hypoxia-ischemia, and induced a partial recovery of EEG amplitude from 1 to 6 h in newborn piglets.
Similarly to the studies with rodents, it was also proved that CBD exert a long-lasting protection;
The neurobehavioral analysis showed that the animals that were treated with CBD had a faster and more significant functional recovery compared to animals that received vehicle. (12,13)
Altogether, these studies using both rodent and non-rodent animal models strongly suggest that CBD may be a safe and effective drug to be used during the acute and sub-acute phases after ischemic stroke, and is currently the best suited cannabinoid to be implemented for clinical use in babies affected by neonatal encephalopathy.
How to supplement
Although the best source of CBD derives from high-CBD cannabis strain, many CBD oil preparations are also extracted from hemp, for legal reasons.
Amongst the commercially available CBD oils, the mean average contents are a mere 0.173% THC while providing levels of CBD measuring at > 3%, which ensures safe consumption free of significant psychoactive effects. Strains are considered CBD-rich when the CBD content level 4% or above.
CBD for newborns is best administered as an oil or extract, or even as a suppository; however, if you choose the latter, we recommend checking out our latest article regarding absorption of suppositories.
Feel free to learn more about CBD in other articles!
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Parents gave their 6-month-old son CBD oil while he was going through chemo. They say ‘a drop the size of a grain of rice’ stopped his vomiting almost instantly.
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- When Danielle and Brian Dwyer’s son Waldo was six months old, he was diagnosed with a rare form of eye cancer that required chemotherapy.
- After starting chemo, Waldo couldn’t sleep, had trouble eating and going to the bathroom, and kept vomiting.
- In search of a solution, the Philadelphia-based family went to California to get CBD oil for Waldo, which was illegal in their home state at the time.
- “We gave him a drop the size of a grain of rice and he was eating, laughing, going to the bathroom again,” Brian Dwyer said of the cannabis oil’s effects on his son. “Within the first hour of giving it to him, he stopped throwing up.”
- Their story is the topic of the 2019 Tribeca Film Festival documentary “Waldo on Weed,” which is executive produced by Whoopi Goldberg. .
When Waldo Dwyer was six months old, his parents Danielle and Brian realized he had trouble seeing.
Soon after, they learned Waldo had a rare childhood form of the eye cancer retinoblastoma . He needed chemotherapy, which caused all sorts of unpleasant side effects, including vomiting, insomnia, and trouble eating.
” Everything we had been growing to know of Waldo [and his personality] was disappearing,” Brian told INSIDER.
Prescription anti-nausea and pain medications didn’t seem to help with the symptoms. The Dwyers were desperate to help their toddler. When Brian’s friends suggested he look into cannabis oil as an alternative treatment, the Dwyers regained a bit of hope.
After doing extensive research, they flew from their Philadelphia, Pennsylvania home to California, where they obtained the CBD oil that ultimately helped Waldo cope with his chemo side effects. Marijuana products (including CBD oil) were illegal in Pennsylvania at the time, but legal in California.
The Tribeca Film Festival documentary “Waldo on Weed,” which was executive produced by cannabis advocate and actress Whoopi Goldberg, premiered on May 3, and details the family’s journey.
The Dwyers saw near-instant results when they gave Waldo cannabis oil
When they gave their son his first dose of CBD oil — “a drop the size of a grain of rice” — Waldo stopped throwing up within an hour. The Dwyers were shocked.
” Before that he was crying on the floor and had lockjaw,” Brian said.
Before giving Waldo the CBD oil, Brian and Danielle spoke with with Dina Browner, a California-based marijuana consultant who owns a dispensary and offers cannabis advice to celebrities like Snoop Dogg. ” She gave us dosing instructions and connected us with other parents and helped us feel at ease,” Danielle said.
According to Danielle, Browner suggested starting Waldo off with a small dose of CBD oil. The oil they used contains the active ingredient cannabidiol, a non-psychoactive component in cannabis, plus negligible amounts of the psychoactive component THC — not enough to get Waldo high.
” We followed the doctor’s protocol for chemo and blood tests and used cannabis oil alongside of that in secret because it wasn’t legal at the time,” Danielle said.
In addition to hiding the decision from Waldo’s doctors, the Dwyers only told a select few family members and friends about their decision.
“We didn’t want this to get out, child protective services getting involved, and Waldo being taken away. It wasn’t until the bill was passed in Pennsylvania [for medical marijuana] we felt comfortable talking about it,” Brian said.
Some cannabis compounds are found in prescription drugs, but CBD isn’t one of them
While research on the medicinal use of various cannabis compounds is still in the early stages, a pair of prescription drugs containing THC are already on the market.
The synthetic cannabinoids dronabinol and nabilone are available as anti-nausea medications for people going through chemotherapy. The drugs are both synthetic versions of the psychoactive compound THC — they aren’t derived from cannabis plants.
There are no chemo-related prescription CBD drugs on the market, but a cancer pain relief medication called Nabiximols is being tested in clinical trials in the US. It’s a mouth spray that contains a near-equal ratio of THC and CBD, and it’s already available in Canada and some parts of Europe.
No protocol exists for giving kids CBD oil or other cannabis products
The lack of research on the substance and its largely illegal status makes it impossible for medical professionals to offer advice on giving cannabis to kids.
According to Dr. Paul Mitrani, clinical director at the Child Mind Institute, CBD products in particular range in quality, and sellers don’t always properly disclose exactly what’s in the products they’re selling. Other concerns include potential interactions with medications and the possibility of kids building a tolerance or dependence on CBD, according to the Child Mind Institute’s website.
Find the right dosage of CBD oil for kids is also difficult, since clinical doses used in studies may be different than what’s offered in cannabis shops, according to the Child Mind Institute.
Waldo is now healthy, and his story has had a lasting impact
Now five years old, Waldo is tumor-free. His vision, which was damaged during treatment, is being corrected. He wears glasses that his mom says make him look “super cute.”
The now-legal status of medical marijuana in Pennsylvania allowed the Dwyers to openly share their story and participate in the Waldo on Weed documentary. Over the past two years, Brian said he’s been inundated with social media messages from parents who are going through similar situations.
They’re desperate for ways to help their children manage pain and to get their hands on cannabis products that are oftentimes illegal in their home states, so the Dwyers offer as much advice as they can.
“This [film] is for all of the other Waldos who are searching for answers,” Brian said.