|MedWatch – The FDA Safety Information and Adverse Event Reporting Program|
|A MedWatch Safety Alert was added to the FDA MedWatch webpage.
TOPIC: Ivermectin Intended for Animals: Letter to Stakeholders – Do Not Use in Humans as a Treatment for COVID-19
AUDIENCE: Consumer, Health Professional, Pharmacy, Veterinary
ISSUE: FDA is concerned about the health of consumers who may self-medicate by taking ivermectin products intended for animals, thinking they can be a substitute for ivermectin intended for humans.
|BACKGROUND: The FDA’s Center for Veterinary Medicine has recently become aware of increased public visibility of the antiparasitic drug ivermectin after the announcement of a research article that described the effect of ivermectin on SARS-CoV-2 in a laboratory setting. The Antiviral Research pre-publication paper, “The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro” documents how SARS-CoV-2 (the virus that causes COVID-19) responded to ivermectin when exposed in a petri dish. These types of laboratory studies are commonly used at an early stage of drug development.
No ivermectin was administered to humans in this study. Additional testing is needed to determine whether ivermectin might be appropriate to prevent or treat coronavirus or COVID-19.
RECOMMENDATION: Ivermectin is not approved for the treatment of COVID-19. People should not take any form of ivermectin unless it has been prescribed by a licensed health care provider and is obtained through a legitimate source. People should never take animal drugs, as the FDA has only evaluated their safety and effectiveness in the particular animal species for which they are labeled. These animal drugs can cause serious harm in people. Ivermectin tablets are approved for use in humans for the treatment of some parasitic worms (intestinal strongyloidiasis and onchocerciasis) and ivermectin topical formulations are approved for human use by prescription only for the treatment of external parasites such as headlice and for skin conditions such as rosacea.
Please help us protect public health by alerting FDA of anyone claiming to have a product to prevent or cure COVID-19 and to help safeguard human and animal health by reporting any of these products to FDA-COVID-19-Fraudulent-Products@fda.hhs.gov or 1-888-InfoFDA (1-888-463-6332).
U.S. Food and Drug Administration