The Food and Drug Administration (FDA) advises the public against the purchase and use of Ivermectin veterinary products against COVID-19.
Currently, the registered Ivermectin products in the country for human use are in topical formulations under prescription use only. This is used for the treatment of external parasites such as head lice and skin conditions such as rosacea.
The registered oral and intravenous preparations of Ivermectin are veterinary products which are approved for use in animals for the prevention of heartworm disease and treatment of internal and external parasites in certain animal species. The drug is an important part of a parasite control program for some animal species and should only be administered according to its approved indication, or as prescribed by a duly licensed veterinarian.
The public is warned against taking animal drugs, as the FDA has only evaluated their safety and efficacy in the particular species for which they are labeled. Using these products in humans can cause serious harm. Animal drugs are often highly concentrated and can be highly toxic to humans.
Any use of Ivermectin veterinary products for the prevention or treatment of COVID-19 should be avoided as the benefits and safety for this purpose has not been established. Data from clinical trials are necessary to determine whether Ivermectin is safe and effective in treating or preventing COVID-19.
Ivermectin is not approved by the FDA for treatment of any viral infection.
For more information and inquiries, please e-mail us at [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8 809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link:https://primaryreporting.whoumc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.
Dissemination of the information to all concerned is highly requested.
Attachment:->FDA Advisory No.2021-0526