Ivermectin Toxicity Reviewed

A comprehensive review of ivermectin reveals that it is among the safest and most well-tolerated drugs ever introduced to the market.

In this episode I walk through an expert review of ivermectin by Jacques Descotes MD, PharmD, PhD which was conducted in early 2021.

In here we discuss the safety, toxicity and known side effects and drug interactions, few and mild as they are.

I felt this material needed to be brought out into the public to help assure we are having complete conversations founded on the latest data.

The conclusion is that “ivermectin human toxicity cannot be claimed to be a serious cause for concern.”

Episode 25 links:

Link to Toxicology report (requires email for free PDF download):

https://www.medincell.com/ivermectin/

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How safe is Ivermectin?

Today I’m going to review an outstanding toxicological in medical review of Ivermectin. Come on let’s go take a look!

Take a look at my background here is a reminder I did go to Duke University it says here I graduated on the 14th of May 1995.

This is a degree from the department of pathology and within there I had a sub-specialty in toxicology. So everything I’m about to tell you today is right within my wheelhouse – this when I went to school for, this is what I studied so let’s take a look. And as a quick other piece of background this is Doyle Graham the principal investigator whose lab I studied in and he was instrumental in my training and Michael Sheets here was somebody at work with quite a bit and this is an example of a paper that I wrote and went into as we can see here into toxicology and applied pharmacology TAP. One of the leading journals in toxicology.

So with that out of the way, here is the paper I want to review today. This is put together by a man named Jacques Descotes, MD, PharmD, and a PhD… so this guy’s got credentials all over the place. Professor Emeritus at a university in Lyon. He’s is a fellow of the US Academy of toxicological Sciences (that’s big position) and well he’s a Eurotox registered toxicologist, so obviously very accomplished. He’s got 146 publications to his name and a lot of  citations (2443 citations at time of recording)… you can find that there. So Jacques put together a toxicological review for a company and around this ivermectin substance. So this is an expert review report that you didn’t do any original research hear what he did was he scan through hundreds and hundreds of articles and online citations in order to develop a comprehensive review of ivermectin and its safety profile at the request of Medincell SA (France).

“I, the undersigned certify to have perused the publicly available information relevant to conduct an extensive analysis of ivermectin safety in human beings. The aim of the present review is to propose an independent evaluative judgement of this information which includes original scientific publications and literature reviews, case reports and any other source provided it can be indisputably tracked down and freely accessed. The author personally collected and reviewed all the cited information from the beginning of September 2020 to the end of February 2021”

That was a multi-month investigation.

A little background here: when we talk about ivermectin this is from that paper and by the way you can download this paper yourself:

Link to Toxicology report (requires email for free PDF download): https://www.medincell.com/ivermectin/

By the way this link requires an email which you provide free that will then allow you to download this PDF which is the one we are looking at.  So that’s how you get to it.

Alright ivermectin background: what did he put as an executive summary…

He said ivermectin was first approved AS A HUMAN MEDICINE in 1987, and in addition to 40 Years of extensive use as a veterinary medicine, it has been prescribed to HUNDREDS OF MILLIONS OF HUMAN BEINGS WORLDWIDE to prevent or treat a variety of parasitic diseases.

Recently, until anti-SARS-VoV-2 activity of ivermectin became the focus of numerous experimental studies and clinical trials, the results and interpretation of which generated a vigorous and still on going debate to establish how effective Ivermectin is or could be against covid-19.

Drug approvals by regulatory authorities rely on a risk+benefit analysis. Benefit is assessed from clinical trials conducted in full compliance with guidelines.  Severe adverse reactions are often too rare to enable clinical trials to generate accurate quantitative incidence data. Pharmacovigilance  (or post-marketing surveillance) is another essential source of information on drug safety. The aim of this expert review report is to propose an independent and fair assessment of ivermectin medical safety profile based on an extensive analysis of the publicly available information (over 500 articles and Web sources) taking into account known limitations and it’s uncertainties at the time of writing.

5:03.

This is how a very careful scientist would write. This is obviously am experience person writing.. really being very careful to know what they know and they’re going to help point out what they don’t know what the data can tell us what it can’t tell us.

The conclusions are right up front is the assessment of reported adverse events temporally associated with ivermectin treatment shows that the adverse effects of ivermectin used to be a infrequent (less than 2 to 5% of treated patients) and mild to moderate.

So the reported adverse events are very mild and infrequent.

They mainly consist of dizziness, tremor, tingling and sleepiness, fever and fatigue & headache, nausea, abdominal pain, diarrhoea, transient tachycardia (beathing heart) and orthostatic hypotension; pruritus and rash.

Again, this is under 5% of treated patients would notice anything at all and as this article goes on to really point out a lot of those side effects that are noted those adverse reactions that are noted besides being mild to moderate, are actually noted in people who have really strong parasitic infections so

Is it ivermectin causing those side effects or the fact that the ivermectin is killing a lot of those parasites that’s causing those reactions to come forward?

Continue: Quote:

More severe neurological complications (eg seizures, confusion, ancephalopathy) are possible, but rare. They essentially developed in susceptible individuals, particularly in patients with a severe form of a parasitic disease, such as Onchocerciasis or Loa-Loa microfilariasis.

So these people would had a some sort of parasitic disease that if they give them Ivermectin some of these rare but more severe neurological complications have been noted with their exceedingly rare (will get to the data in adjust a second)

Continue: Quote:

A sudden in market drop in blood pressure, skin reaction, liver injury have been mentioned in early safety reviews.  The clinical experience accumulated over the years showed these severe adverse events are unequivocally extremely rare.  

Quote in YELLOW:
The often-reiterated claim, even today, that ivermectin can be lethal in treated patients only rests on a ONE-PAGE CORRESPONDENCE to the Lancet published in 1997.  This claim is deemed to be unfounded as it has never been further substantiated until today and instead, subsequent publications repeatedly showed this claim was either incorrect of methodologically inaccurate.

So that’s the only thing that he could find in the entire literature that spoke about any sort of a lethal complication.

So in here as well (very useful info) he noted that the pharmacodynamics is very important here writing:

In humans the reported elimination half-lives of ivermectin used to range between 12 hours and 35 hours.

So a “half-live” is how long, if you took a dose, how long before half of it was cleared out of your system – 12 to 35 hours… so that’s half a day to a day and a half.

That Ivermectin oral bioavailability is 2.6 times higher in fed verses unfed human beings let to formal recommendations for ivermectin administration.  

So some people would say they take it with food because the point is to get it into your system, and that’s what’s noted here.

However, clinical data about a food affect on ivermectin pharmacokinetics are scarce. 

So we don’t have a lot of good date around that.

Recent human studies found only minimal, if any food effect.

Still open the question, he’s got the citation – the original citation was in 2002.  More recently the citation in 2020  says that there’s only minimal effect if any on food effect, so it is a little bit up in the air.  This is what science looks like: we think we know something, then we think we don’t know something, we learn more as we go.  I like the carefulness of this report.

Repeat Dose Toxicity:

For repeat dosing :

The repeated dose toxicity of Ivermectin was assessed in a 3-month oral study in mice,

Quick aside:

 

Postmarketing Surveillance   Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance. Since drugs and medical devices are approved on the basis of clinical trials, which involve relatively small numbers of people who have been selected for this purpose – meaning that they normally do not have other medical conditions which may exist in the general population – postmarketing surveillance can further refine, or confirm or deny, the safety of a drug or device after it is used in the general population by large numbers of people who have a wide variety of medical conditions.[1]   https://en.wikipedia.org/wiki/Postmarketing_surveillance

When you’re doing a toxicology study, you are trying to ask a question like, “How toxic is this stuff”.  You might try a toxicity study in vitro first.  You would do it on just cells floating around in a medium or plated down onto a glass substrate or plastic.  You could do that in vitro study and if you pour it on, you can find out, “oh at this lever, these cells die.)  The next layer up is in vivo where you’re doing in a whole animal so might run a mouse model or a rat or guinea pig model, could be dogs, could be cats, could be monkeys, right?  In each of these animal models you are going to get different results because all animals respond differently to these things.  So when we look at animal models the gold standard is in a primate. Of course the GOLD GOLD standard is what happens to humans, obviously that’s what we’re interested in here. But if you can’t experiment on humans, primates would give you the next best read.

Below that things get a little murky, particularly when you are looking at reproductive effects or whats happening to cardiovascular issues, etc.  These things are more difficult to assess when that happens to another species than a primate or human.  But even still that’s where we start in toxicology studies; we’re asking what happens what happens in rats, what happens in mice? Things like that and if something happens there then we’ll know to look more carefully in other animal models and maybe even in humans postmarketing so that’s postmarketing vigilance.

Postmarketing Surveillance Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance. Since drugs and medical devices are approved on the basis of clinical trials, which involve relatively small numbers of people who have been selected for this purpose – meaning that they normally do not have other medical conditions which may exist in the general population – postmarketing surveillance can further refine, or confirm or deny, the safety of a drug or device after it is used in the general population by large numbers of people who have a wide variety of medical conditions.[1] https://en.wikipedia.org/wiki/Postmarketing_surveillance

What they found:

a 4-week dermal study … so they putting on the outsides of these animals and they did 3- and 6-minth oral studies in Sprague Dawley rats, in 3- and 9-month or study in Beagle dogs, a 2-week dermal study and a 2-week, 3- and 6-month dermal studies in minipigs, and finally a 2-week oral study in rhesus monkeys ie the Gold Standard we want to look at.

And we have something called Estimated NOAEL (no observed adverse effect level).

Ok let’s look at the data that came out from that (same pdf from Jacques’ great toxicology review:

15:30

Toxicity Reaction

Conclusion: Current doses are well within the known toxicity parameters.

Continue to watch the video (about 20 minutes further) for more information about toxicity levels of Ivermectin.

PS: Ivermectin is safer than Tylenol!

17:15

The safety parameter of Ivermectin against known dosing regiments is very well tolerated well within the safety bands.

18:36

… if you take a 100 times the therapeutically recommended dose of paracetamol (Tylenol / Panadol), you’re not coming out of the hospital.