Operational details:
Ivermectin is an antiparasitic agent that is FDA-approved for treatment of strongyloidiasis, scabies, pediculosis (lice infestation), and onchocerciasis. Ivermectin can be prescribed in tablet form or topically for these parasitic conditions. Although ivermectin has some in vitro activity against some viruses, including SARS-CoV-2, the concentrations required exceed those achieved in plasma and lung tissue with safe dosing in vivo. The quality of available clinical trial evidence with ivermectin is limited, and available evidence failed to show a reduction in mortality, viral clearance, or symptom duration. In ambulatory patients the evidence is also very uncertain, and available data fail to show any benefit in terms of avoidance of progression to severe disease, or viral clearance at day 7. Ivermectin is generally well tolerated in doses typically used to treat parasitic infections, but the drug has risk of significant toxicity at higher doses.
• Ivermectin is not authorized or approved by the FDA for prevention or treatment of COVID-19.
• Given the lack of evidence of benefit, both the NIH and Infectious Disease Society of America COVID-19 Treatment Guidelines recommend against use of Ivermectin for ambulatory or hospitalized patients to prevent or treat COVID-19, unless in the context of a clinical trial.
• A joint statement released on 9/1/21 by the American Medical Association, the American Pharmacists Association, and the American Society of Health-system Pharmacists strongly opposes the ordering, prescribing, or dispensing of Ivermectin to prevent or treat COVID-19 outside of a clinical trial. Our physician and pharmacy leadership concur with this joint statement.
• The CDC issued a Health Advisory on 8/26/21 that noted a dramatic increase in Ivermectin prescribing through retail pharmacy as well as reports of toxicity from individuals using over the counter veterinary preparations of Ivermectin to self-treat COVID-19. Adverse effects from Ivermectin misuse and overdose are increasing, as evidenced by an increase in calls to poison control centers in multiple states.
•Providers should educate patient about the risks of taking ivermectin without a prescription, or ingesting Ivermectin formulations meant for external use or formulations meant for veterinary use.
• Patients should be encouraged instead to get vaccinated against COVID-19, wear masks in indoor public spaces, practice social distancing, avoid crowds, and practice regular hand hygiene.
• Advise patients to immediately seek medical treatment if they have taken Ivermectin and are experiencing symptoms of toxicity such as gastrointestinal effects (nausea, vomiting, abdominal pain, diarrhea), headache, blurred vision, dizziness, tachycardia, hypotension, hallucinations, altered mental status/confusion, loss of balance, CNS depression, and seizures. Call the poison control center hotline (1-800-222-1222) for medical management advice.
Resources
AMA, APhA, ASHP statement on ending use of ivermectin to treat COVID-19.
https://www.ama-assn.org/press-center/press-releases/ama-apha-ashp-statement-ending-use-ivermectin-treat-covid-19 9/1/2021
Food and Drug Administration- Why you should not use ivermectin to treat or prevent COVID-19.
https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19 9/3/2021
Centers for Disease Control and Prevention- Rapid increase in ivermectin prescriptions and reports of severe illness associated with use of products containing ivermectin to prevent or treat COVID-19.
https://emergency.cdc.gov/han/2021/han00449.asp 8/26/2021
National Institutes of Health COVID-19 Treatment Guidelines- Ivermectin.
https://www.covid19treatmentguidelines.nih.gov/therapies/antiviral-therapy/ivermectin/ 2/11/2021
Infectious Disease Society of America Guidelines on the Treatment and Management of Patients with COVID-19
https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/ 9/3/2021