Ivermectin is not an approved treatment for COVID-19
Applicable To: Mercy Care Complete Care, Mercy Care DD, Mercy Care DCS CHP, Mercy Care Long Term Care, Mercy Care RBHA and Mercy Care Advantage
There have been many reports recently about oral ivermectin treating COVID-19 infections, reducing mortality, speeding recovery and possibly preventing infections after exposure to the COVID-19 virus.
Ivermectin is a Food and Drug Administration (FDA) approved antiparasitic drug that is used to treat several neglected tropical diseases, including onchocerciasis and helminthiases.
Oral Ivermectin is well-tolerated when used as directed for its approved indication, strongyloidiasis, an infection caused by roundworm or off-label for lice and scabies. Adverse effects include nausea, diarrhea, dizziness, itching .1
In vitro studies of Ivermectin has been shown to inhibit the replication of SARS-CoV-2 virus in cell cultures.2 However pharmacokinetic and pharmacodynamic studies show achieving this level for its antiviral effect would require doses up to 100-fold higher than those approved in humans.3
Overdose, can cause vomiting, hypotension, ataxia, seizures, coma, and death.
Several meta-analyses have highlighted that the effect of ivermectin in patients with COVID-19 remains uncertain because of a lack of high-quality data. The studies could not find benefit for mortality, recovery, or viral clearance or as prophylaxis. 4,5
The American Medical Association, American Society of Health-System Pharmacists, and the American Pharmacists Association oppose ivermectin use for COVID-19 except in a clinical trial. The National Institute of Health (NIH) guidance recommends neither for nor against ivermectin for COVID-19 treatment due to insufficient evidence.1
Mercy Care and Mercy Care Advantage cover Ivermectin in doses and durations consistent with FDA-approved indications. Uses that are not approved including for COVID-19, i.e. off-label and that are not supported in standard reference compendia as accepted safe and effective treatments are considered experimental and/or investigational. Such therapies are not a covered benefit.
References
1. NIH. Coronavirus disease 2019 (COVID-19). Treatment guidelines. Last updated October 27, 2021. https://covid19treatmentguidelines.nih.gov/. (Accessed November 13, 2021)
2. Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020;178:104787. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32251768.
3. 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(10):1122-1133. Available at:
4. Roman YM, Burela PA, Pasupuleti V, et al. Ivermectin for the treatment of COVID-19: a systematic review and meta-analysis of randomized controlled trials. Clin Infect Dis 2021 Jun 28. doi: 10.1093/cid/ciab591.
5. Popp M, Stegemann M, Metzendorf MI. et al. Ivermectin for preventing and treating COVID-19. Cochrane Database Syst Rev 2021;(7):CD015017.
Thanks for all you do!
