April 15, 2020
The Michigan Department of Agriculture and Rural Development and the Michigan Department of Health and Human Services are warning the public against the promotion or use of the drug ivermectin in the prevention or treatment of COVID-19.
Ivermectin is approved by the U.S. Food and Drug Administration 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, as well as humans.
Recently, the drug has gained some attention due to a pre-publication paper for the journal Antiviral Research. The paper documents how SARS-CoV-2 (the virus that causes COVID-19) responded to ivermectin when exposed in a petri dish. Ivermectin was not given to people or animals in this study.
“We cannot emphasize this strongly enough: this study was not tested in humans or in animals,” said State Veterinarian Nora Wineland. “It was done in a petri dish. As intriguing as the results may be, at this point, they mean little to nothing in the actual prevention or treatment of COVID-19 in either animals or humans. Ivermectin sold for use in animals has not been evaluated for safety in species other than those listed on the label and may cause serious harm if taken by people.”
“We understand Michiganders’ concerns about COVID-19 and the desire to find a cure quickly,” said Dr. Joneigh Khaldun, chief medical executive and chief deputy for health. “However, there are no approved preventive medications for COVID-19 in humans, and we do not want anyone being harmed by taking medications inappropriately. Staying home and practicing good public health practices like washing hands frequently, wearing a homemade mask if you must go out, and covering coughs and sneezes appropriately is the best way to slow the spread of COVID-19.”
Warnings from these state agencies follow similar warnings from the U.S. Food and Drug Administration, which sent a letter to stakeholders on April 10.
In the letter, the FDA states it 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.”
The FDA has established a cross-agency task force dedicated to closely monitoring for fraudulent COVID-19 products. 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. To report anyone claiming to have a product to prevent or cure COVID-19, send an email to FDA-COVID-19-Fraudulent-Products@fda.hhs.gov or call 888-InfoFDA (888-463-6332).