Fact Check: FDA Did NOT Approve Ivermectin As COVID-19 Treatment

Not Endorsing

Was ivermectin approved by the U.S. Food and Drug Administration (FDA) as a treatment for COVID-19 in August 2023? No, that’s not true: The FDA has not granted approval of the anti-parasitic drug for treating the virus. Clinical studies and scientific evidence have not established the safety or efficacy of ivermectin for this purpose.

The claim appeared in a post on X, the social media platform formerly known as Twitter, published by White Wabbit Warrior 🐇⚔️ on August 11, 2023, under the title “FDA Drops Ivermectin Bombshell.” The post’s caption reads:

Remember when it was horsepaste? When everyone called you an idiot for even considering it when there was this ‘miracle vaccine?’
Remember when it was demonized?

Yeah, so the FDA finally approved it.

This is what the post looked like on Twitter at the time of writing:

(Source: Twitter screenshot taken on Tue Aug 15 15:24:08 2023 UTC)

The post cites an article from ZeroHedge.com (archived here) titled “FDA Drops Ivermectin Bombshell,” which cites a story from The Epoch Times (archived here) with the title “Doctors Can Prescribe Ivermectin for COVID-19: FDA Lawyer.”

Court case

The claim that the FDA approved the use of ivermectin to treat COVID hangs on a quote made by Ashley Cheung Honold, a Department of Justice lawyer representing the agency during oral arguments on August 8, 2023, in the U.S. Court of Appeals for the 5th Circuit in the case “Apter et al v. Department Of Health And Human Services et al.” Three doctors filed the case, accusing the FDA of wrongfully intervening in their medical practice. At the 22:25 mark in the video, Honold says:

FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID.

Food and Drug Administration

Does Honold’s statement imply that the FDA endorses the utilization of ivermectin for treating COVID, even when doctors are authorized to prescribe it in general? The answer is no. In an August 15, 2023, email to Lead Stories, FDA Press Officer Chanapa Tantibanchachai provided the agency’s response. It said:

Currently, FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans.

Authorized uses

In humans, the FDA has granted approval for the use of ivermectin tablets in addressing intestinal strongyloidiasis and onchocerciasis, both of which are illnesses resulting from parasitic worms. Additionally, specific topical variations of ivermectin have been sanctioned for combatting external parasites like head lice, as well as for managing skin conditions like rosacea.

Ivermectin studies

Since early in the pandemic, many studies into the efficacy of ivermectin have been conducted, and, as of the time of this writing, they have not found conclusive evidence that ivermectin defeats or has a major impact on the virus that causes COVID.

Dr. William Schaffner, a professor of medicine in the division of infectious diseases at Vanderbilt University Medical Center, told Lead Stories that the evidence falls heavily on the side against the drug as a COVID treatment. In a July 20, 2023, phone interview, he said:

There are a few small studies, usually very small and not very well controlled, with highly selected patients, that would suggest that ivermectin has some utility. On the other hand, there have been a whole series of studies now that are larger, rigorously well-designed, and very well-controlled. These studies have indicated that ivermectin neither prevents the development of serious disease nor has a notable effect in the treatment of the disease once the illness has become evident.

A February 20, 2023, editor’s note published on the American Medical Association’s JAMA Network website casts additional doubt on the use of the anti-parasitic as a COVID treatment. The note, “At a Higher Dose and Longer Duration, Ivermectin Still Not Effective Against COVID-19,” is a follow-up on a “meta-analysis of 11 eligible trials examining the efficacy of ivermectin for the treatment of COVID-19,” which was published in April 2022, and “concluded that ivermectin has no beneficial effect for people with COVID-19.”

The editor’s note examines three additional large randomized clinical trials, including several thousand participants, that reached similar conclusions as the original 11.

The authors said:

Today JAMA publishes a new trial of ivermectin treatment for mild to moderate COVID-19 that addresses the possibility that the existing literature may have missed the efficacy of ivermectin because the previously tested dose (approximately 400 μg/kg daily for 3 days) was insufficient. At a higher treatment dose (600 μg/kg daily) and longer treatment duration (6 days), Naggie and colleagues again conclude that ivermectin is not beneficial for the treatment of COVID-19.

At the doses and durations tested in these studies, ivermectin does not appear to be associated with serious adverse effects. However, a generally well-tolerated therapy that lacks efficacy can still be dangerous, particularly if it results in patients forgoing other interventions with proven efficacy, such as evidence-based COVID-19 treatments or vaccination against SARS-CoV-2. Ivermectin has been used throughout the pandemic. Although the current prevalence of ivermectin use in the US and globally is difficult to determine, reports in the lay media as well as our own experience as clinicians suggest that use of ivermectin for COVID-19 has not fully abated, fueled in part by real or perceived lack of access to effective therapies, continued confusion or misinformation, and active disinformation about ivermectin’s efficacy, including by physicians.

In an emergency newsletter to clinicians, the Centers for Disease Control and Prevention (CDC) warned against “using ivermectin to prevent or treat COVID-19 in humans.” The CDC went on to say:

The National Institutes of Health (NIH) COVID-19 Treatment Guidelines Panel has determined that there are currently insufficient data to recommend using ivermectin to treat COVID-19. Clinicians and public health practitioners should educate patients about the risks of using ivermectin without an indication or prescription, as well as about the risks of ingesting ivermectin products that are meant solely for external use or veterinary use. COVID-19 vaccination is safe and the most effective means to prevent infection and protect against severe disease and death from SARS-CoV-2, the virus that causes COVID-19. Clinicians are strongly encouraged to educate patients to use proven COVID-19 prevention measures, especially getting vaccinated and boosted as soon as eligible, and use FDA-authorized treatment.

Read more

Additional Lead Stories fact checks of claims involving ivermectin are available here.

Other Lead Stories fact checks of claims about COVID vaccination can be found here.