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Food and Drug Administration and Compliance Issues
Friday, April 10, 2020
FDA Letter to Stakeholders: Do Not Use Ivermectin Intended for Animals as Treatment for COVID-19 in Humans
April 10, 2020
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. This type of study is commonly used in the early stages of drug development. Ivermectin was not given to people or animals in this study. Additional testing is needed to determine whether ivermectin might be safe or effective to prevent or treat coronavirus or COVID-19.
Ivermectin tablets are approved for use in people 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 skin conditions such as rosacea. Ivermectin is FDA-approved for use in animals for prevention of heartworm disease in some small animal species, and for treatment of certain internal and external parasites in various animal species.
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. 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. People should not take any form of ivermectin unless it has been prescribed to them by a licensed health care provider and is obtained through a legitimate source.
Ivermectin is an important part of a parasite control program for certain species and should only be given to animals for approved uses or as prescribed by a veterinarian in compliance with the requirements for extra-label drug use. Due to potentially elevated interest in ivermectin following the new research, some products may not be available. If you are having difficulty locating a particular ivermectin product for your animal(s), the FDA recommends that you consult with your veterinarian.
The FDA has established a cross-agency task force dedicated to closely monitoring for fraudulent COVID-19 products that reaches out to major retailers to ask for their help in monitoring online marketplaces. Products that claim to prevent, diagnose, treat, or cure COVID-19 are subject to FDA investigation and potential enforcement action if they have not demonstrated safety and effectiveness for that intended use. The task force has already worked with retailers to remove dozens of these types of product listings online.
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).
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