Ivermectin still not effective or approved for COVID-19 treatment, FDA says

(NEXSTAR) — As COVID-19 cases rise across the U.S. — and a new variant emerges —misinformation about treatment or prevention of the disease perseveres. In an effort to combat a flurry of recent social media posts touting the use of deworming drug ivermectin, the FDA is reminding people why it never approved it as a COVID-19 treatment.

"Although FDA has approved ivermectin for certain uses in humans and animals, it has not authorized or approved ivermectin for use in preventing or treating COVID-19, nor has the agency stated that it is safe or effective for that use," the FDA said on its social channels.

The FDA pointed to recently updated National Institutes of Health COVID-19 treatment guidelines, which not only don't approve of its use but recommend against it due to inefficiency and lack of evidence.

While some studies on ivermectin as COVID-19 treatment do exist and some do testify to the drug’s efficacy, that data is overwhelmingly considered inconsistent, questionable and/or inconclusive by experts.

It's important to remember COVID-19 is a virus, not a parasite, and would not be targeted by ivermectin being introduced in the body.

Medical experts say the data affirming ivermectin's use for COVID-19 is insignificant compared to the amount indicating it’s useless. A previous review of 14 ivermectin studies concluded these studies were small and “few are considered high quality.” The researchers say they’re uncertain about the efficacy and safety of the drug and that “reliable evidence” doesn’t support using ivermectin for COVID-19 treatment outside of well-designed randomized trials. Meanwhile, a February 2023 review in Future Virology of some ivermectin-affirming studies explained that some used too-small pools of participants, were rushed, and ignored limitations around how ivermectin is absorbed in the body.

"It must be acknowledged that some of these studies were possibly intentionally designed to yield predetermined findings," write the researchers.

Among many most recent studies are a Journal of the American Medical Association-published randomized ivermectin vs. placebo clinical trial which concluded there was no support for ivermectin use for patients with mild to moderate COVID-19. A February 2023 Duke University researcher-led randomized clinical trial upped the dosage from the previous ivermectin vs. placebo clinical trial — finding there was no difference in efficacy even at a higher dosage.

Other major health organizations advising against use of ivermectin for COVID-19 include: the World Health Organization, European Medicines Agency, Infectious Diseases Society of America, and the U.S. National Institutes of Health. Additionally, pharmaceutical company Merck, a manufacturer of ivermectin, says there’s “no meaningful evidence” to support its use in this way.

Back in 2021, the country’s largest doctors group, the American Medical Association, called on U.S. doctors to stop prescribing ivermectin for COVID-19 treatment.

As previously mentioned, ivermectin does have some approved uses — though knowledge of the drug and its popularity soared with the onset of the coronavirus pandemic. The FDA said back in 2021 that over 88,000 prescriptions for the drug were dispensed in a month period that year. Before the pandemic, about 3,600 ivermectin prescriptions were dispensed per year.

The FLCCC

Some of the support for ivermectin's COVID-19 misuse can be traced to the many conservative and media personalities who promoted ivermectin, including former Fox News host Tucker Carlson and podcast host Joe Rogan, who claimed to have taken it himself.

One vocal group behind ivermectin's proliferation is the Front Line COVID-19 Critical Care Alliance, a group of doctors whose recommendations and treatments have been labeled "dubious." The FLCCC is behind the website “covid19criticalcare.com,” which purports to offer “prevention and treatment protocols for COVID-19.” In addition to the use of ivermectin, it’s indicated that a person gargle with mouthwash, take vitamins and administer nasal drops containing iodine.

Among the FLCCC’s resources on ivermectin is a review published in the American Journal of Therapeutics. It’s co-authored by one member of the alliance and relies to some degree (at least 15.5%, according to academic journal Nature) on a non-peer-reviewed preprint that was withdrawn due to “ethical concerns.”

That paper allegedly studied a large sample size of COVID-19 symptomatic people and found that ivermectin significantly reduced symptoms and deaths. But academics and critics found issues related to plagiarism and data manipulation, Nature reports.

A highly-cited January 2022 study published in Cureus which claimed to find that "ivermectin was associated with significantly reduced COVID-19 infection, hospitalization, and death rates from COVID-19" was later flagged and corrected by the publisher.

In the correction, Cureus explained that "several authors failed to disclose all relevant conflicts of interest when submitting this article." According to Cureus, all but one researcher was affiliated with the FLCCC. Additionally, at least two of the authors were found to be paid consultants for ivermectin manufacturer Vitamedic.

The alliance lists a disclaimer on its website, reading in part: "... in no way should anyone infer that we, even though we are physicians, or anyone appearing in any content on this website are practicing medicine, it is for educational purposes only."

Nexstar reached out to the FLCCC for comment and will update as it responds.

As of Friday, many recent popular ivermectin-promoting Facebook posts have been flagged as False Information and debunked by independent fact-checkers.

The FDA reiterated this week that Americans should talk to their health care providers about available COVID-19 treatment options and vaccines, which have been proven to be effective.