A recent study indicated the positive effect of ivermectin on SARS-CoV-2 (the virus that causes COVID-19) in a laboratory setting. The paper showed how SARS-CoV-2 responded to ivermectin in a petri dish.
The FDA stated: "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."
The agency's stance echoes the reaction of Merck Animal Health to the latest research. Merck Animal Health that based on the concentrations of ivermectin shown to achieve an antiviral effect in vitro, it calculated the amount of ivermectin needed to reach similar exposures in people "would significantly exceed the doses known to be safe and well tolerated".
Ivermectin tablets are approved for use in humans for the treatment of some parasitic worms, while topical formulations of the molecule are approved for human use by prescription-only for the treatment of external parasites such as head-lice and skin conditions such as rosacea.
Ivermectin is also FDA-approved for the prevention of heartworm disease in some small animal species and for treatment of certain parasites in various animal species.
The agency added: "The 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."
The FDA also noted some products may not be currently available due to the elevated interest in ivermectin following the release of the new research.
The agency has established a cross-agency task force to closely monitor for fraudulent COVID-19 products. This team is contacting major retailers to ask for their help in monitoring online marketplaces.