From Center for Disease Control (CDC – Press Release August 26, 2021)
Ivermectin is a U.S. Food and Drug Administration (FDA)-approved prescription medication used to treat certain infections caused by internal and external parasites. When used as prescribed for approved indications, it is generally safe and well-tolerated.During the COVID-19 pandemic, ivermectin dispensing by retail pharmacies has increased, as has the use of veterinary formulations available over the counter but not intended for human use. FDA has cautioned about the potential risks of use for prevention or treatment of COVID-19.
Ivermectin is not authorized or approved by FDA for the prevention or treatment of COVID-19. The National Institutes of Health’s (NIH) COVID-19 Treatment Guidelines Panel has also determined that there are currently insufficient data to recommend ivermectin for treatment of COVID-19. ClinicalTrials.gov has listings of ongoing clinical trials that might provide more information about these hypothesized uses in the future.
Adverse effects associated with ivermectin misuse and overdose are increasing, as shown by a rise in calls to poison control centers reporting overdoses and more people experiencing adverse effects.
Ivermectin is a medication that is approved by FDA in oral formulations to treat onchocerciasis (river blindness) and intestinal strongyloidiasis. Topical formulations are used to treat head lice and rosacea. Ivermectin is also used in veterinary applications to prevent or treat internal and external parasitic infections in animals. When used in appropriate doses for approved indications, ivermectin is generally well tolerated.
Clinical trials and observational studies to evaluate the use of ivermectin to prevent and treat COVID-19 in humans have yielded insufficient evidence for the NIH COVID-19 Treatment Guidelines Panel to recommend its use. Data from adequately sized, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19.
A recent study examining trends in ivermectin dispensing from outpatient retail pharmacies in the United States during the COVID-19 pandemic showed an increase from an average of 3,600 prescriptions per week at the pre-pandemic baseline (March 16, 2019–March 13, 2020) to a peak of 39,000 prescriptions in the week ending on January 8, 2021.1 Since early July 2021, outpatient ivermectin dispensing has again begun to rapidly increase, reaching more than 88,000 prescriptions in the week ending August 13, 2021. This represents a 24-fold increase from the pre-pandemic baseline. (Figure)
Figure: Estimated number of outpatient ivermectin prescriptions dispensed from retail pharmacies — United States, March 16, 2019–August 13, 2021*
*Data are from the IQVIA National Prescription Audit Weekly (NPA Weekly) database. NPA Weekly collects data from a sample of approximately 48,900 U.S. retail pharmacies, representing 92% of all retail prescription activity. Ivermectin dispensed by mail order and long-term care pharmacies, prescriptions by veterinarians, and non-oral formulations were not included.
In 2021, poison control centers across the U.S. received a three-fold increase in the number of calls for human exposures to ivermectin in January 2021 compared to the pre-pandemic baseline.
In some cases, people have ingested ivermectin-containing products purchased without a prescription, including topical formulations and veterinary products. Veterinary formulations intended for use in large animals such as horses, sheep, and cattle (e.g., “sheep drench,” injection formulations, and “pour-on” products for cattle) can be highly concentrated and result in overdoses when used by humans. Animal products may also contain inactive ingredients that have not been evaluated for use in humans. People who take inappropriately high doses of ivermectin above FDA-recommended dosing may experience toxic effects.
Clinical effects of ivermectin overdose include gastrointestinal symptoms such as nausea, vomiting, and diarrhea. Overdoses are associated with hypotension and neurologic effects such as decreased consciousness, confusion, hallucinations, seizures, coma, and death. Ivermectin may potentiate the effects of other drugs that cause central nervous system depression such as benzodiazepines and barbiturates.
Examples of recent significant adverse effects reported to U.S. poison control centers include the following:
Recommendations for Clinicians and Public Health Practitioners
Recommendations for the Public
For More Information
FDA Consumer Alert on Use of Ivermectin to Treat or Prevent COVID-19
FDA MedWatch Adverse Event Reporting program
CDC Coronavirus (COVID-19) website
U.S. Government Coronavirus (COVID-19) website
American Association of Poison Control Centers
Press Release: American College of Medical Toxicology Reports Data on Adverse Effects and Toxicity from Unapproved Use of Ivermectin for the Prevention or Treatment of COVID-19
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