Editor’s note: The American Pharmacists Association and American Society of Health-System Pharmacists have joined the AMA to release a statement that strongly opposes the ordering, prescribing or dispensing of ivermectin to prevent or treat COVID-19 outside of a clinical trial.
What’s the news: The Centers for Disease Control and Prevention (CDC) has issued a health advisory warning physicians and the public about the rise in prescriptions for the anti-parasitic drug ivermectin for use in the treatment or prevention of COVID-19. The CDC also cautioned about the risk of severe illness caused by ivermectin, which was seen in increased calls to poison centers.
The Food and Drug Administration (FDA) echoed the CDC’s warning against the use of ivermectin for prevention or treatment of COVID-19. That is because ivermectin is not approved or authorized by the FDA for COVID-19. Additionally, the National Institutes of Health’s (NIH) COVID-19 Treatment Guidelines Panel determined that there is insufficient evidence and data to recommend ivermectin for treatment of COVID-19. This recommendation is consistent with the Infectious Disease Society of America’s Guidelines on the Treatment and Management of Patients with COVID-19, which speaks against the use of ivermectin in hospitalized patients and ambulatory persons with COVID-19, outside of the context of a clinical trial. There is also no evidence to suggest that ivermectin can be used to successfully prevent COVID-19 infection.
“Clinical trials and observational studies to evaluate the use of ivermectin to prevent and treat COVID-19 in humans have yielded insufficient evidence for the NIH COVID-19 Treatment Guidelines Panel to recommend its use,” the CDC health alert explains. “Data from adequately sized, well-designed and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19.”
A recent study cited by the CDC found that ivermectin dispensing from outpatient retail pharmacies in the U.S. increased from an average of 3,600 prescriptions per week at the pre-pandemic baseline to a peak of 39,000 prescriptions in the week ending Jan. 8, 2021.
Then, since early July, outpatient ivermectin dispensing was on the rise again, rapidly increasing to more than 88,000 prescriptions in the week ending Aug. 13. According to the CDC, this represents a 24-fold increase. This growing interest in ivermectin to treat humans with COVID-19 has led to an increase in calls to poison control reporting overdoses and adverse effects.
Why it’s important: For months, different news and social media outlets have talked about ivermectin being used to treat COVID-19. It has also been a popular topic on Twitter and was even touted as a miracle drug. But this is not the case.
While ivermectin is an FDA-approved prescription medication used to treat certain infections caused by internal and external parasites, it is not authorized or approved for prevention or treatment of COVID-19.
“Using any treatment for COVID-19 that’s not approved or authorized by the FDA, unless part of a clinical trial, can cause serious harm,” says the FDA’s consumer update.
Taking a drug for an unapproved use can be very dangerous and misinformation that says it is OK to take ivermectin for COVID-19—or in large doses—is wrong, the FDA consumer update warns. Even approved levels of ivermectin can interact with other medications such as blood thinners. Overdose of ivermectin can also cause nausea, vomiting, diarrhea, hypotension, allergic reactions, dizziness, ataxia, seizures, coma and even death.
And when it comes to animal formulations of ivermectin and other medicines, they are highly concentrated because they are intended for use in large animals such as horses and cows, says the FDA’s consumer update. That makes these veterinary medicine formulations extremely toxic in humans.
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. Discover eight coronavirus tips that doctors wish patients would follow.
Learn more: It is vital that everyone get vaccinated against COVID-19. There are three COVID-19 vaccines currently available with two—Moderna and Johnson & Johnson—approved by the FDA through emergency use authorization.
The FDA recently granted full approval of the Pfizer-BioNTech COVID-19 vaccine. These COVID-19 vaccines are the safest, most effective way to protect against severe disease and death from SARS-CoV-2. Vaccination also helps protect individuals from the dangerous Delta variant.
The AMA has developed a COVID-19 resource center as well as a physician’s guide to COVID-19 to give doctors a comprehensive place to find the latest resources and updates from the CDC and the World Health Organization.
Additionally, the AMA offers an overview of foundational guidance regarding medical ethics for health professionals and institutions responding to the COVID-19 pandemic such as prescribing medications responsibly.