Exhibit 2 (FDA FAQ on COVID-19 and Ivermectin) — Apter v. HHS

Summary

This Exhibit 2, filed as Document 12-2 on 08/08/22 in Case 3:22-cv-00184, reproduces the FDA web page "FAQ: COVID-19 and Ivermectin Intended for Animals." The page answers No to whether people should take ivermectin to prevent or treat COVID-19, and says a laboratory study of ivermectin's effect on SARS-CoV-2 was an early-stage study that needs additional testing. It states that ivermectin tablets are approved in humans for some parasitic worms and topical formulations for headlice and rosacea, that animal ivermectin is approved for heartworm prevention and certain parasites, and that people should never take animal drugs. It closes with possible side effects and FDA's work with retailers and the Federal Trade Commission against fraudulent COVID-19 products.

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Case 3:22-cv-00184 Document 12-2 Filed on 08/08/22 in TXSD Page 1 of 3
Exhibit 2
Case 3:22-cv-00184 [illegible] BoaPage 2 of 3
FAQ: COVID-19 and Ivermectin Intended for Animals
Q: Should I take ivermectin to prevent or treat COVID-19?
A: No. While there are approved uses for ivermectin in people and animals, it is not approved for the prevention or treatment of COVID-19. You
should not take any medicine to treat or prevent COVID-19 unless it has been prescribed to you by your health care provider and acquired from a
legitimate source.
A recently released research article (https://pdf.sciencedirectassets.com/271065/AIP/1-s2.0-S0166354220302011/main.pdf?X-Amz-
Date=20200406T215853Z&X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-
[illegible]
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[illegible] ogxrga&pii=S0166354220302011&X-Amz-SignedHeaders=host&X-Amz-Security-
Token=IQoJb3JpZ2luX2VjEKX%2F%2F%2F%2F%2F%2F%2F%2F%2F%2FWEACXVZLWVhc3QtMSJHMEUCIAI%2F6GH7KtIFhbG5MZc%2BiCG7X1S\
[illegible] (http://www.fda.gov/about-fda/website-
policies/website-disclaimer) described the effect of ivermectin on SARS-CoV-2 in a laboratory setting. These types of laboratory studies are
commonly used at an early stage of drug development. Additional testing is needed to determine whether ivermectin might be appropriate to prevent
or treat coronavirus or COVID-19.
Q: Is there an emergency use authorization for ivermectin in the U.S. to prevent or treat
coronavirus or COVID-19?
A: No. FDA has created a special emergency program for possible therapies, the Coronavirus Treatment Acceleration Program (/drugs/coronavirus-
covid-19-drugs/coronavirus-treatment-acceleration-program-ctap) (CTAP). It uses every available method to move new treatments to patients as
quickly as possible, while at the same time finding out whether they are helpful or harmful. We continue to support clinical trials that are testing new
treatments for COVID so that we can gain valuable knowledge about their safety and effectiveness.
Q: What is ivermectin approved for in the U.S.?
A: 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.
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. People should never take animal drugs, as the FDA has only evaluated their safety and
effectiveness in the particular species for which they are labeled. Using these products in humans could cause serious harm.
Q: Is there any danger to humans taking ivermectin?
A: There are approved uses for ivermectin in people and animals but it is not approved for the prevention or treatment of COVID-19. You should not
take any medicine to treat or prevent COVID-19 unless it has been prescribed to you by your health care provider and acquired from a legitimate
source.
Some of the side-effects that may be associated with ivermectin include skin rash, nausea, vomiting, diarrhea, stomach pain, facial or limb swelling,
neurologic adverse events (dizziness, seizures, confusion), sudden drop in blood pressure, severe skin rash potentially requiring hospitalization and
liver injury (hepatitis). Laboratory test abnormalities include decrease in white cell count and elevated liver tests. Any use of ivermectin for the
prevention or treatment of COVID-19 should be avoided as its benefits and safety for these purposes have not been established. Data from clinical
trials are necessary for us to determine whether ivermectin is safe and effective in treating or preventing COVID-19.
Q: What should I do if the ivermectin products I purchase for use in my animals are not available
at my typical retailer?
A: 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.
Q: What is the FDA doing to protect people from fraudulent COVID-19 products?
https://www.fda.gov/animal-veterinary/product-safety-information/faq-covid-19-and-ivermectin-intended-for-animals 1/2
Case 3:22-cv-00184 [illegible] 3 of 3
A: We have established a cross-agency task force dedicated to closely monitoring for fraudulent COVID-19 products. We have reached out to major
retailers to ask for their help in monitoring online marketplaces for fraudulent COVID-19 products. Products sold are subject to FDA investigation
and potential enforcement action if they claim to prevent, diagnose, treat, or cure COVID-19 and 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.
The FDA and the Federal Trade Commission (FTC) issue warning letters to companies that violate federal law and pose significant risks to patient
health by selling unapproved products with fraudulent claims to treat or prevent COVID-19. View the warning letters (/consumers/health-fraud-
Additional Information
FDA Letter to Stakeholders: Do Not Use Ivermectin [illegible] at [illegible] as Treatment for COVID- =19 in Humans (/animal-veterinary/product-
i i 19-humans)
Why You Should Not Use Ivermectin to Treat or Prevent COVID-19 (/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-
prevent-covid-19)
https://www.fda.gov/animal-veterinary/product-safety-information/faq-covid-19-and-ivermectin-intended-animals 2/2


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