Exhibit 1 (FDA Ivermectin Consumer Update) — Apter v. HHS

Summary

Exhibit 1 attached to Document 12 in Case 3:22-cv-00184, filed in TXSD on August 8, 2022, reproduces the FDA web page "Why You Should Not Use Ivermectin to Treat or Prevent COVID-19." The page warns that taking large doses of ivermectin is dangerous and that people should never use medications intended for animals on themselves or other people, because animal drugs are often highly concentrated for large animals like horses and cows. It notes that ivermectin is approved for human use to treat some parasitic worms, head lice and skin conditions like rosacea, and that clinical trials of ivermectin tablets for COVID-19 are ongoing. Readers are told to fill any ivermectin prescription through a legitimate source such as a pharmacy and take it exactly as prescribed.

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Case 3:22-cv-00184 Document 12-1 Filed on 08/08/22 in TXSD Page 1 of 4

Exhibit 1
Case 3:22-cv-00184 Document 12-1 Filed on 08/08/22 in TXSD Page 2 of 4

Why You Should Not Use Ivermectin to Treat or Prevent COVID-19

Espafiol (/consumers/articulos-en-espanol/por-que-no-debe-utilizar-ivermectina-para-tratar-o-prevenir-el-covid-19)

Portugués (/consumers/consumer-updates/por-que-voce-nao-deve-usar-ivermectina-para-tratar-ou-prevenir-covid-19)

FAX (/consumers/consumer-updates/weishenmebuyinggaishiyongyiweijunsuzhiliaohuoyufang201 9xinguanfeiyan)

Tagalog (/consumers/consumer-updates/bakit-hindi-ka-dapat-gumamit-ng-ivermectin-upang-gamutin-o-maiwasan-ang-covid-19)
Tiéng Viét (/consumers/consumer-updates/tai-sao-ban-khong-nen-su-dung-ivermectin-de-dieu-tri-hoac-ngan-ngua-covid-19)

ot Of (/consumers/consumer-updates/kobideu-1 9-covid-1 9leul-chilyohago-yebanghagi-wihayeo-ibeomegtineul-sayonghaji-malaya-haneun-iyu)

COVID-19. We've been living with it for what sometimes seems like forever. Given the number of deaths that
have occurred from the disease, it’s perhaps not surprising that some consumers are turning to drugs not
approved or authorized by the Food and Drug Administration (FDA).

One of the FDA’s jobs is to carefully evaluate the scientific data on a drug to be sure that it is both safe and
effective for a particular use. In some instances, it can be highly dangerous to use a medicine for the prevention
or treatment of COVID-19 that has not been approved by or has not received emergency use authorization
from the FDA.

There seems to be a growing interest in a drug called ivermectin for the prevention or treatment of COVID-19 in
humans. Certain animal formulations of ivermectin such as pour-on, injectable, paste, and "drench," are
approved in the U.S. to treat or prevent parasites in animals. For humans, ivermectin tablets are approved at
very specific doses to treat some parasitic worms, and there are topical (on the skin) formulations for head lice
and skin conditions like rosacea.
Case 3:22-cv-00184 Document 12-1 Filed on 08/08/22 in TXSD Page 3 of 4

However, the FDA has received multiple reports of patients who have required medical attention, including
hospitalization, after self-medicating with ivermectin intended for livestock.

Here's What You Need to Know about Ivermectin

¢ The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in
humans or animals. Ivermectin is approved for human use to treat infections caused by some parasitic
worms and head lice and skin conditions like rosacea.

¢ Currently available data do not show ivermectin is effective against COVID-19. Clinical trials
(https://www.clinicaltrials.gov/ct2/results?cond=COVID-
19&term=ivermectin&cntry=&state=&city=&dist=&Search=Search) assessing ivermectin tablets for the

prevention or treatment of COVID-19 in people are ongoing.
¢ Taking large doses of ivermectin is dangerous.

¢ If your health care provider writes you an ivermectin prescription, fill it through a legitimate source such
as a pharmacy, and take it exactly as prescribed.

¢ Never use medications intended for animals on yourself or other people. Animal ivermectin products are
very different from those approved for humans. Use of animal ivermectin for the prevention or treatment
of COVID-19 in humans is dangerous.

What is Ivermectin and How is it Used?

Ivermectin tablets are approved by the FDA to treat people with intestinal strongyloidiasis and onchocerciasis,
two conditions caused by parasitic worms. In addition, some topical forms of ivermectin are approved to treat
external parasites like head lice and for skin conditions such as rosacea.

Some forms of animal ivermectin are approved to prevent heartworm disease and treat certain internal and
external parasites. It’s important to note that these products are different from the ones for people, and safe
only when used in animals as prescribed.

When Can Taking Ivermectin Be Unsafe?

The FDA has not authorized or approved ivermectin for the treatment or prevention of COVID-19 in people or
animals. Ivermectin has not been shown to be safe or effective for these indications.

There’s a lot of misinformation around, and you may have heard that it’s okay to take large doses of ivermectin.
It is not okay.

Even the levels of ivermectin for approved human uses can interact with other medications, like blood-thinners.
You can also overdose on ivermectin, which can cause nausea, vomiting, diarrhea, hypotension (low blood
pressure), allergic reactions (itching and hives), dizziness, ataxia (problems with balance), seizures, coma and
even death.

Ivermectin Products for Animals Are Different from Ivermectin Products
for People
Case 3:22-cv-00184 Document 12-1 Filed on 08/08/22 in TXSD Page 4 of 4

For one thing, animal drugs are often highly concentrated because they are used for large animals like horses
and cows, which weigh a lot more than we do— up to a ton or more. Such high doses can be highly toxic in
humans. Moreover, the FDA reviews drugs not just for safety and effectiveness of the active ingredients, but
also for the inactive ingredients. Many inactive ingredients found in products for animals aren’t evaluated for
use in people. Or they are included in much greater quantity than those used in people. In some cases, we don’t
know how those inactive ingredients will affect how ivermectin is absorbed in the human body.

Options for Preventing and Treating COVID-19

The most effective ways to limit the spread of COVID-19 (https://www.cdc.gov/coronavirus/2019-
ncov/prevent-getting-sick/prevention.html) include getting a COVID-19 vaccine when it is available to you and
following current CDC guidance.

Talk to your health care provider about available COVID-19 vaccines and treatment options. Your provider can
help determine the best option for you, based on your health history.


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