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  • Letter to the FDA about dosage and repurposing trials

     TheRealRestoreInc. updated 5 days, 12 hours ago 1 Member · 2 Posts
  • TheRealRestoreInc.

    Member
    July 21, 2021 at 2:05 pm

    To FDA Product Safety Investigation Department:

    I am currently researching the safety of a product approved by FDA.

    The product is not strictly veterinary nor human use. And ivermectin is antiviral.

    PROOF

    “Ivermectin exerts broad-spectrum antiviral activity against several animal and human viruses, including both RNA and DNA viruses.”

    SOURCE OF TEXT

    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7261036/

    This product has been used for veterinary and human use. The usual dosage for either human or animal is based on body weight, therefore it is important for human safety to determine if the dose of the product is of the same concentration for both veterinary or human use. It is the same concentration from my research, 0.2 mg/Kg of body weight doses for both equines and humans.

    The FDA website for COVID-19 informs the public that:

    “The FDA has received multiple reports of patients who have required medical support and been hospitalized after self-medicating with ivermectin intended for horses.”

    “Here’s What You Need to Know about Ivermectin”

    “FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans. Ivermectin tablets are approved at very specific doses for some parasitic worms, and there are topical (on the skin) formulations for head lice and skin conditions like rosacea. Ivermectin is not an anti-viral (a drug for treating viruses).”

    “Taking large doses of this drug is dangerous and can cause serious harm.”

    “If you have a prescription for ivermectin for an FDA-approved use, get it from a legitimate source and take it exactly as prescribed.”

    “Never use medications intended for animals on yourself. Ivermectin preparations for animals are very different from those approved for humans.”

    “Ivermectin Products for Animals Are Different from Ivermectin Products for People”

    “For one thing, animal drugs are often highly concentrated because they are used for large animals like horses and cows, which can weigh a lot more than we do—a ton or more. Such high doses can be highly toxic in humans.”

    “Moreover, FDA reviews drugs not just for safety and effectiveness of the active ingredients, but also for the inactive ingredients. Many inactive ingredients found in animal products aren’t evaluated for use in people. Or they are included in much greater quantity than those used in people. In some cases, we don’t know how those inactive ingredients will affect how ivermectin is absorbed in the human body.”

    http://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19#:~:text=Ivermectin%20is%20often%20used%20in%20the%20U.S.%20to,use%20in%20treating%20or%20preventing%20COVID-19%20in%20humans.

    So my research shows that such statements above, ie., “we don’t know”, are not true. There are opportunities for a safety trial of volunteer human subjects to prove that equine paste ivermectin at 1.87%, is not toxic at 0.2 mg/ Kg of body weight. The FDA website warnings are inaccurate, for the majority of equine ivermectin products in paste or gel form (1.87% and dosage of 0.2 mg/Kg).

    There is much real world evidence that shows the safety of products made by Bimeda and Farnam for owners of expensive equines employed in activities such as racing, rodeo, city horsecart rides, trail rides, breeding and ranch work.

    People who have used ivermectin for scabies and rosacea

    It is therefore safe enough of a product in veterinary formulation in paste or gel form, at the same dosage for equines – 0.2 mg/Kg. Real World Evidence is something FDA can study, without bias for regulating a product. The results of an unbiased study about whether equine 1.87% ivermectin in paste or gel form is safe at standard dosage would do much to give FDA the information that FDA now does not have.

    I have researched this formulation of ivermectin. Over 98% of the ingredients are not ivermectin, but a delivery medium (a paste or gel). There are secrets being kept about the added ingredients, by the manufacturers themselves, but the Safety Data Sheets show that the added ingredients Acute Toxicity LD 50 in rats are nearly impossible to ingest. As for the main ingredient ivermectin, it is pharmacologically equivalent to human use ivermectin, and may be at LD 50 in humans at a dose of 10 mg/Kg of body weight in humans. This would extrapolate to an LD 50 Acute Toxicity dose of 680 mg for a 68 kg or 150 lbs of body weight.

    I have researched the evidence of reported results by persons taking this form of veterinary compound for scabies and rosacea and have found no evidence of gross or widespread misuse and subsequent adverse reactions. Permanent reactions and death are unheard of for this usage. As for those trying 1.87% equine paste or gel as a way to stop or slow SARS-CoV-2 infection, why not, as I mentioned before, sponsor a voluntary clinical trial that studies this reporposing of a compound that has been repurposed many times before, for many reasons? Perhaps you will discover that the paste delivery system is better suited to human recovery from COVID-19 symptoms than you feared, and that the formulation, as it exists, is ready to use to lower the Covid-19 infection numbers, duration of symptoms and number of deaths.

    What is there to lose but pride?

    Best regards,

    [name withheld]

    Restore!, Inc.

    Ivermectin (70288-86-7)

    LD50 Oral Rat

    http://www.durvet.com/wp-content/uploads/2017/09/Ivermectin-Paste_Bimeda_112015_SDS.pdf

  • TheRealRestoreInc.

    Member
    July 23, 2021 at 2:55 pm

    FDA’s Reply to my letter shows how to apply for veterinary ivermectin repurposing for Covid-19, but not encouraging.

    Dear [name withheld],

    Thank you for writing to the Division of Drug Information in the FDA’s Center for Drug Evaluation and Research (CDER).

    We appreciate that you chose to share your concerns and suggestions with us.

    While there are approved uses for ivermectin in people and animals, it is not approved for the prevention or treatment of COVID-19. You should not take any medicine to treat or prevent COVID-19 unless it has been prescribed to you by your health care provider and acquired from a legitimate source.

    FDA has issued the following public statements and resources related to Ivermectin and COVID-19:

    FDA Letter to Stakeholders: Do Not Use Ivermectin Intended for Animals as Treatment for COVID-19 in Humans

    FAQ: COVID-19 and Ivermectin Intended for Animals

    A recently released research article described the effect of ivermectin on SARS-CoV-2 in a laboratory setting. These types of laboratory studies are commonly used at an early stage of drug development. Additional testing is needed to determine whether ivermectin might be appropriate to prevent or treat coronavirus or COVID-19.

    Please understand that, in general, FDA does not conduct clinical studies. In order for a human drug to be marketed in the United States for a certain use (such as ivermectin for the treatment of COVID-19), an organization or company (also called the sponsor) must submit a New Drug Application to the FDA demonstrating the drug is both safe and effective for its intended use. A new use for a previously approved drug may also require a New Drug Application. Through review of the New Drug Application and data submitted by the sponsor, the FDA determines whether the evidence is sufficient to demonstrate safety and efficacy of the drug for the intended use. To get a general idea of what information is required to prove safety and efficacy please see The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective

    FDA remains actively engaged with partners across the U.S. government, academia and regulated industry to expedite the development and availability of critical medical products to prevent and treat this novel virus – this work includes collecting data in a variety of ways to both evaluate the safety and efficacy of potential therapies and facilitate emergency access for patients, as appropriate.

    For the latest updates from FDA, visit: Coronavirus Disease 2019 (COVID-19)

    Best Regards,

    KC

    Pharmacist

    Division of Drug Information

    Center for Drug Evaluation and Research

    Tel: 855-543-DRUG (855-543-3784)

    This communication is consistent with 21 CFR 10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

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