FDA says Ivermectin remains ineffective and unapproved for COVID-19 treatment


(NEXSTAR) — In the midst of rising COVID-19 cases in the U.S. and the emergence of a new variant, there continues to be misinformation circulating about the disease’s treatment and prevention. The FDA is taking action to combat the recent surge in social media posts promoting the use of the deworming drug ivermectin by reminding the public that it has not approved ivermectin as a treatment for COVID-19.

The FDA stated on its social channels, “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 referred to the recently updated National Institutes of Health COVID-19 treatment guidelines, which not only do not approve of the use of ivermectin, but also recommend against it due to its inefficiency and lack of evidence.

Although there are some studies that suggest ivermectin may be effective as a COVID-19 treatment, the data is inconsistent, questionable, and inconclusive according to experts.

It is important to note that COVID-19 is a virus, not a parasite, and therefore ivermectin, which targets parasites, would not be effective against it.

Medical experts emphasize that the insignificant amount of data supporting ivermectin’s use for COVID-19 is overshadowed by the overwhelming evidence suggesting its ineffectiveness. A previous review of 14 ivermectin studies concluded that the studies were small and of low quality. The researchers express uncertainty about the drug’s efficacy and safety, and state that there is no reliable evidence supporting its use for COVID-19 treatment outside of well-designed randomized trials. Furthermore, a review published in Future Virology in February 2023 highlighted flaws in some studies endorsing the use of ivermectin, including small sample sizes, rushed research, and disregarding important factors related to how the drug is absorbed in the body.

The researchers noted, “It must be acknowledged that some of these studies were possibly intentionally designed to yield predetermined findings.”

Recent studies, such as a randomized clinical trial published in the Journal of the American Medical Association, found no support for the use of ivermectin in patients with mild to moderate COVID-19. Another randomized clinical trial led by Duke University researchers increased the dosage of ivermectin compared to previous trials, but found no difference in efficacy.

Major health organizations, including the World Health Organization, European Medicines Agency, Infectious Diseases Society of America, and the U.S. National Institutes of Health, advise against the use of ivermectin for COVID-19. Even pharmaceutical company Merck, a manufacturer of ivermectin, states that there is “no meaningful evidence” to support its use in this way.

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

Although ivermectin is approved for certain uses, its popularity surged with the onset of the pandemic. In 2021, over 88,000 prescriptions for the drug were dispensed in a month, compared to about 3,600 prescriptions per year before the pandemic.

The FLCCC

The widespread promotion of ivermectin for COVID-19 treatment can be attributed to various conservative and media personalities, including former Fox News host Tucker Carlson and podcast host Joe Rogan, who claimed to have taken ivermectin himself.

One notable group advocating for the use of ivermectin is the Front Line COVID-19 Critical Care Alliance (FLCCC), a group of doctors whose treatments and recommendations have been criticized. The FLCCC operates the website “covid19criticalcare.com,” which offers protocols for COVID-19 prevention and treatment. In addition to ivermectin, their recommendations include gargling with mouthwash, taking vitamins, and using nasal drops containing iodine.

The FLCCC’s resources on ivermectin include a review published in the American Journal of Therapeutics. However, this review relies on a non-peer-reviewed preprint that was withdrawn due to ethical concerns, according to the academic journal Nature.

The withdrawn preprint allegedly reported significant reductions in symptoms and deaths among a large sample size of COVID-19 symptomatic individuals treated with ivermectin. However, academics and critics have raised concerns about plagiarism and data manipulation in the study, as reported by Nature.

A highly-cited study published in January 2022 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

Reference

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