#pediatric

CBD & Seizures

REBUTTAL TO:

“CBD is only approved for seizures assoc w/ LGS & Dravet. Any other use is going beyond the current evidence. There is evidence of harm since CBD has side effects & interacts w/ other meds. We also have no idea what's in these products. Needs regulation”.

I DO NOT agree with this statement there is "evidence for HARM for CBD" [in refractory seizures]. Lets talk about that….

We may not have "enough" clinical trial evidence for efficacy in using CBD in all types seizures. However, we have 1000s of cases in many types of seizures where CBD has forever changed the lives of children living with disabling seizures of various etiologies; where ongoing seizures = loss in brain tissue, function, ability to learn, and further damage to the developing brain. Essentially, I am suggesting we switch to an “n of 1” approach - ie the patient is your subject and control, make one medication change, monitor, reassess and make adjustments. Basically - lets practice the “art” of medicine and use our brains!

The increase in LFT (liver function tests ) was seen in a small number of children in these seizures trials, who were on 3-4+ anti seizure medications, which are all known to be metabolized by the same CYP450 system as CBD. So yes, CBD may have be implicated in the increase in LFT. But that again, does not mean harm, let me explain…

As a physician and pharmacist, I have work WITH many drug interactions when there is clear clinical benefit (ie less seizures) we weigh this against the risks of the medication in question. This is especially true when we are working with patients with refractory diseases, who are NOT responding to their current medications.

Side note: Did you know that 75% of ALL pediatric medication in Canada are use OFF label? That means that either that particular medication was not studied in children at all (who have different metabolism etc than adults), or the drug was not made for seizures to begin with, but anecdotally we have “noticed” it has worked for seizures WITHOUT big “enough” studies to confirm this. More on off label prescribing here.

We CAN monitor for CBD side effects as we are slowly increasing the dose of CBD; sometimes I do drug levels for culprit medication, ie clobazam, (but usually the blood work comes back after I have already made my decision base on the clinical symptoms so I do not find drug level monitoring in this situation very helpful) , or monitor for increase LFTs (this comes back quickly), or get the caregiver to report back to me if there is an increase in fatigue (they know these kids and their behaviors so well). If any of these occur, I have two choices, but it depends on if we have seen a significant reduction in seizures. If no, I can reduce CBD and even discontinue. If we have seen improvement, we can discuss (along with the neurologist), which current anti seizure medication has been least helpful, and consider reducing that one (and the one we think is the most likely to be interacting with CBD). Usually that is clobazam in these complex cases.

In addition to LFT changes, other side effects of CBD reported were fatigue and diarrhea. Most of us would agree that these are COMMON side effects for many other medications. We do not refer to side effects of usual medication "harm" , but we do need to monitor for them and adjust accordingly.

I believe these side effects (increase LFT, fatigue and possible diarrhea) reported in Dravet and LGS seizures was due to the high doses of CBD ie 1000-2000mg + per day. IF we used a product containing CBD in synergistic combination with CBDA, THCA, and very small amount of THC, as naturally found in type III cannabis chemovars (specific type of CBD dominant cannabis plants), we could use much smaller doses of CBD, which would reduce these side effects (we need more research in this area of course). Unfortunately all of the studies were done using "pharma" grade 100% pure CBD, so we have missed the boat in my mind.

TIME IS BRAIN people..... we just can't wait for “enough” CBD evidence, when these children have failed other options and are continuing to have 200-400 seizures a day!

We must shift this conversation to the ART of medicine ; using clinical judgment, experience, and stop quoting headlines and making sweeping generalizations. This is NOT helping our patients, and is actually causing more harm and fear.

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CBC- Phasing out medical cannabis would leave pediatric patients in the lurch

By: Jenna Valleriani & Caroline MacCallum, September 8, 2018 for CBC News

Physicians in Canada are prescribing cannabis. They have been doing so for years, and will likely continue to do so after recreational cannabis is legalized this fall. But the Canadian Medical Association (CMA) says that doctors in Canada want to see the phasing out of the medical cannabis access program once pot is legalized. And no doubt, some do…

The CMA's position on cannabis for medical purposes is that there is "insufficient evidence on risks and benefits, the proper dosage and potential interactions with other medication." However, this view ignores thousands of peer-reviewed journal articles and studies that provide evidence of the efficacy of cannabis use for some medical conditions — chronic pain, as one example. While we do not deny that more clinical studies are needed, surely the publishing of over 10,000 peer reviewed articles signals that the use of cannabis in medical treatment is not some fringe endeavour.

There are numerous risks in eliminating a medical stream of cannabis access — risks that include things like the loss of guidance around dosing and administration, contraindications to cannabis use, screening for dependency risk and potential drug interactions. Essentially, it ignores the realities physicians are facing on the ground.  

But there's one critical topic that has been left completely out of consideration regarding the issue of narrowing cannabis access to just the recreational stream: youth under the legal age of access…

See full article here