written by Dr. Valerie Donaldson
September 16, 2021
Ivermectin Warning from FDA
On 3-5-21, reposted 9-3-21, the FDA posted an article ‘Why You Should Not Use Ivermectin to Treat or Prevent Covid-19’.* The FDA states,
“You can also overdose on ivermectin, which can cause nausea, vomiting, diarrhea, hypotension (low blood pressure), allergic reactions (itching and hives), dizziness, ataxia (problems with balance), seizures, coma, and even death.”
The FDA article is written without references. The FDA did not comment on adverse effects using therapeutic doses. Ivermectin dosing should be directed by the physician. If anyone has any side effects from Ivermectin they should stop the medication.
Safety using Ivermectin
Safety using Ivermectin is summarized in Dr. Kory’s research article, ‘Review of the Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19’:**
- “Numerous studies report low rates of adverse events, with the majority mild, transient, and largely attributed to the body’s inflammatory response to the death of the parasites and includes itching, rash, swollen lymph nodes, joint paints, fever, and headache.75
- In a study that combined results from trials including more than 50,000 patients, serious events occurred in less than 1% and largely associated with administration in Loa loa.76(a worm)
- Furthermore, according to the pharmaceutical reference standard Lexicomp, the only medications contraindicated for use with ivermectin are the concurrent administration of antituberculosis and cholera vaccines while the anticoagulant warfarin would require dose monitoring.
- Another special caution is that immunosuppressed or organ transplant patients who are on calcineurin inhibitors, such as tacrolimus or cyclosporine, or the immunosuppressant sirolimus should have close monitoring of drug levels when on ivermectin given that interactions exist that can affect these levels.
- A longer list of drug interactions can be found on the comdatabase, with nearly all interactions leading to a possibility of either increased or decreased blood levels of ivermectin.
- Given studies showing tolerance and lack of adverse effects in human subjects given escalating high doses of ivermectin, toxicity is unlikely; although, a reduced efficacy because of decreased levels may be a concern.77
- Concerns of safety in the setting of liver disease are unfounded given that,
- Some have described ivermectin as potentially neurotoxic,
- yet one study performed a search of a global pharmaceutical database and found only 28 cases among almost 4 billion doses with serious neurological adverse events, such as ataxia, altered consciousness, seizure, or tremor.80
- Potential explanations included the effects of concomitantly administered drugs that increase absorption past the blood–brain barrier or polymorphisms in the mdr-1 gene.
- However, the total number of reported cases suggests that such events are exceedingly rare.
- Finally, ivermectin has been used safely in pregnant women, children, and infants.”
Merck statement on Ivermectin and Covid*****
- “Ivermectin should not be used during pregnancy since safety in pregnancy has not been established.
- Ivermectin is excreted in human milk in low concentrations. Treatment of mothers who intend to breast-feed should only be undertaken when the risk of delayed treatment to the mother outweighs the possible risk to the newborn.
- Rarely, patients with onchocerciasis who are also heavily infected with Loa Loa may develop a serious or even fatal encephalopathy following treatment with an effective microfilaricide.”
In another paper published August 2021 reviewing Ivermectin’s use for Covid:****
- “IVM has been safely used in 3.7 billion doses since 1987,
- Well-tolerated even at much greater than standard doses,
- and used without serious adverse events in the three high-dose COVID-19 treatment studies noted…”
Incidence of Neurological Adverse Events after Ivermectin?
‘Serious Neurological Adverse Events after Ivermectin-Do they Occur beyond the Indication of Onchocerciasis?’
According to this paper, using a worldwide data base reviewing adverse effects through 2016, only 28 cases out of over 3 billion doses were found.
“Examples of serious neurological adverse events reported included such terms as unable to walk, consciousness disturbed or depressed level of consciousness or loss of consciousness, seizure or convulsion, encephalopathy or coma, and tremor. The reported dosages of ivermectin ranged between 3 and 24 mg with no suggestion of overdose.”
In 17 cases symptoms could be explained by other drugs being given simultaneously leaving 11 cases due to Ivermectin alone. The incidence of serious side effects due to Ivermectin would then be approximately 0.000000003%. The explanation for these individuals is a possible gene mutation called mdr-1 that would carry Ivermectin into the brain.
There is mention of 2 deaths out of these 17 cases from Ivermectin in over 3 billion doses given. The deaths happened after 2 therapeutic doses in patients with worms and multiple system problems, and certainly not from overdoses.
Given the above research, it appears Ivermectin is extremely safe. Hence, a prescription written off-label by a physician for Ivermectin for Covid should never be refused by a pharmacy as is happening now, especially if there is a chance a patient could incur serious morbidity by not taking it. Where are the rights of patient and physician? Why is this happening?
Do your own research. See what you find. Let me know. We all should know the facts.
Have an awesome day! Dr. D
**https://journals.lww.com/americantherapeutics/fulltext/2021/06000/review_of_the_emerging_evidence_demonstrating_the.4.aspx A Review of the Emerging Evidence by Kory
Aguirre-Chang G. Post-Acute or prolonged COVID-19: treatment with ivermectin for patients with persistent, or post-acute symptoms ResearchGate. 2020.
Kircik LH, Del Rosso JQ, Layton AM, et al. Over 25 Years of clinical experience with ivermectin: an overview of safety for an increasing number of indications. J Drugs Dermatol. 2016;15:325–332.
Gardon J, Gardon-Wendel N, Demanga N, et al. Serious reactions after mass treatment of onchocerciasis with ivermectin in an area endemic for Loa loa infection. Lancet. 1997;350:18–
Guzzo CA, Furtek CI, Porras AG, et al. Safety, tolerability, and pharmacokinetics of escalating high doses of ivermectin in healthy adult subjects. J Clin Pharmacol. 2002;42:1122–1133.
***80 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5929173/Serious Neurological Adverse Events after Ivermectin-Do They Occur beyond the Indication of Onchocerciasis.
****https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8383101/Aug 2021 Ivermectin: a multifaceted drug of Nobel prize-honored distinction with indicated efficacy against a new global scourge, Covid-19
Reprinted with permission from Regenerative Medicine Center.