AMA/APHA/ASHP Joint Statement on Ivermectin (Exhibit 25) — Apter v. HHS (S.D. Tex.)

Summary

Exhibit 25 (Document 12-25) in Case 3:22-cv-00184, filed August 8, 2022, reproduces the American Medical Association press release in which the AMA, APhA and ASHP call for an immediate end to the prescribing, dispensing and use of ivermectin for the prevention and treatment of COVID-19 outside of a clinical trial. The statement says ivermectin is approved by the FDA for human use to treat infections caused by internal and external parasites and is not approved to prevent or treat COVID-19. It notes that the National Institutes of Health, World Health Organization and Merck all state there is insufficient evidence to support ivermectin to treat COVID-19. It urges physicians, pharmacists and other prescribers to warn patients against ivermectin outside FDA-approved indications and against buying it from online stores.

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PRESS RELEASES

AMA, APhA, ASHP statement on ending use of ivermectin
to treat COVID-19

SEP 1, 2021

WASHINGTON, DC - The American Medical Association (AMA), American Pharmacists
Association (APhA), and American Society of Health-System Pharmacists

(ASHP) strongly oppose the ordering, prescribing, or dispensing of ivermectin to
prevent or treat COVID-19 outside of a clinical trial.

Ivermectin is approved by the U.S. Food and Drug Administration (FDA) for human
use to treat infections caused by internal and external parasites. It is not approved to
prevent or treat COVID-19. Ivermectin is also available to treat certain veterinary
conditions; medications formulated or intended for use in animals should not be
used by humans. We are alarmed by reports that outpatient prescribing for and
dispensing of ivermectin have increased 24-fold since before the pandemic and
increased exponentially over the past few months. As such, we are calling for an
immediate end to the prescribing, dispensing, and use of ivermectin for the
prevention and treatment of COVID-19 outside of a clinical trial. In addition, we are
urging physicians, pharmacists, and other prescribers—trusted health care
professionals in their communities—to warn patients against the use of ivermectin
outside of FDA-approved indications and guidance, whether intended for use in
humans or animals, as well as purchasing ivermectin from online stores. Veterinary
forms of this medication are highly concentrated for large animals and pose a
significant toxicity risk for humans.

The U.S. Centers for Disease Control and Prevention (CDC) and the FDA have issued
advisories indicating that ivermectin is not authorized or approved for the prevention

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or treatment of COVID-19. The National Institutes of Health, World Health
Organization, and Merck (the manufacturer of the drug) all state there is insufficient
evidence to support the use of ivermectin to treat COVID-19. The Infectious Diseases
Society of America Guidelines on the Treatment and Management of Patients with
COVID-19 also recommend against the use of ivermectin outside of a clinical trial.

Use of ivermectin for the prevention and treatment of COVID-19 has been
demonstrated to be harmful to patients. Calls to poison control centers due to
ivermectin ingestion have increased five-fold from their pre-pandemic baseline. A
recent CDC Health Alert Network Advisory (PDF) recommends that health care
professionals should counsel patients against use of ivermectin as a treatment for
COVID-19, including emphasizing the potentially toxic effects of this drug, including
“nausea, vomiting, and diarrhea. Overdoses are associated with hypotension and
neurologic effects such as decreased consciousness, confusion, hallucinations,
seizures, coma, and death.”

For more information, we encourage patients and health care providers to consult
the FDA’s Consumer Update on Why You Should Not Use Ivermectin to Treat or
Prevent COVID-19 and the CDC Health Alert Network Advisory on the Rapid Increase
in lvermectin Prescriptions and Reports of Severe Illness Associated with Products
Containing Ivermectin to Prevent or Treat COVID-19.

Patients are encouraged to talk to their physicians, pharmacists, and other prescribers
about currently available therapies authorized or approved for the treatment or
prevention of COVID-19. The most effective ways to limit the spread of COVID-19 are
to get vaccinated, wear a face mask, stay at least six feet from others in public places,
wash hands frequently, and avoid large crowds of people. Our organizations strongly
urge eligible unvaccinated individuals to get vaccinated.

AMA COVID-19 Resource Center for Physicians

APhA COVID-19 Resource Center

ASHP COVID-19 Resource Center

Media Contact:

AMA Media & Editorial
oh: (312) 464-4430

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media@ama-assn.org

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