The FDA continues to recommend against ivermectin for treating or preventing COVID-19, despite claims to the contrary

Since the early stages of the COVID-19 pandemic, many misleading claims have promoted the ability of ivermectin to treat or prevent COVID-19 despite a lack of evidence. Recently, social media claims have suggested that the U.S. Food and Drug Administration (FDA) has reconsidered its position and permitted ivermectin prescriptions for COVID-19. As this review will explain, this new claim is also misleading.

In fact, the FDA doesn’t have the power to prevent medical doctors from prescribing ivermectin for COVID-19. Therefore the claim that it “now” permits ivermectin use for COVID-19 misrepresents the FDA. The FDA still continues to recommend against it and denied the claims in a tweet. Therefore the implication that the FDA now considers the drug effective against COVID-19 is untrue.

Ivermectin is an antiparasitic drug that has been used for decades to treat a range of parasitic infections in both humans and animals. It has proven highly effective against various parasites, including those causing river blindness, strongyloidiasis, and scabies.

Ivermectin received considerable public attention as a potential COVID-19 treatment after studies reported its antiviral effects against SARS-CoV-2, the virus responsible for COVID-19, in cells in the laboratory^[1].

The results of clinical trials investigating ivermectin for COVID-19 treatment have been mixed and inconclusive^[2]. Larger studies didn’t see improvements in recovery time for COVID-19 patients compared to a placebo drug^[3,4].

Ivermectin isn’t considered a safe or effective treatment for COVID-19

Due to the lack of supporting evidence, public health authorities and regulatory bodies, including the World Health Organization, the U.S. National Institutes of Health, the FDA, and the European Medicines Agency, don’t recommend using ivermectin to treat or prevent COVID-19 except in clinical trials designed for testing these effects.

Despite these recommendations, ivermectin prescriptions for COVID-19 increased significantly. By December 2020, there was almost seven times as much ivermectin prescribed in the U.S. compared to 2019^[5].

In 2021, there were many reports of poisonings among people who had taken ivermectin to treat or prevent COVID-19, having obtained it by prescription or by taking veterinary formulations^[6].

The FDA is responsible for evaluating and approving medications for specific uses based on scientific evidence of safety and efficacy. The process involves rigorous preclinical and clinical studies to ensure that a drug’s benefits outweigh its risks.

Off-label prescription refers to using a medication for a purpose not explicitly approved by the FDA. Healthcare providers can legally prescribe an approved medication off-label if they believe it will benefit the patient. This practice is common and allows for medical flexibility, especially when dealing with complex medical conditions.

Ivermectin is FDA-approved for certain parasitic infections, however healthcare providers have the authority to prescribe it off-label if they choose.

The FDA hasn’t approved ivermectin for COVID-19 or changed its recommendations

A civil suit against the FDA argued that the agency’s public information materials to discourage taking ivermectin for COVID-19 had overstepped its remit and prevented doctors from prescribing it off-label.

During a hearing on 8 August 2023, lawyers for the FDA stated that doctors have the right to prescribe ivermectin and other medications off-label without FDA approval, in keeping with what the FDA previously said publicly. This correctly described the limits of the FDA’s remit, however this statement was misleadingly used to suggest that the FDA had changed its position on ivermectin.

In response to the claims, the FDA tweeted:

“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.”

A widely-viewed video posted on Facebook and TikTok, accumulating more than 1.3 million views altogether, claimed that “the FDA is now saying that it is OK to prescribe ivermectin” and referenced its use for COVID-19. This would lead viewers to wrongly conclude that the FDA changed its position on the effectiveness of ivermectin against COVID-19. However, this was not the case; the FDA only restated that doctors have always had the legal right to prescribe the drug off-label.

Similarly, headlines for articles by the Gateway Pundit and Zero Hedge claimed “FDA Lawyer Admits Doctors Can Prescribe Ivermectin for COVID-19” and “FDA Drops Ivermectin Bombshell”, respectively. The use of the words “admits” or “bombshell” misleads readers to believe that this is new information that the FDA had tried to conceal. In fact, off-label use of medicines is a common practice that is already widely acknowledged, including by the FDA, and the FDA lawyers’ statements weren’t a revelation by the FDA.

Conclusion

The FDA’s stance on ivermectin remains unchanged—the drug remains unapproved for COVID-19. Since before the pandemic, doctors have been able to prescribe ivermectin off-label as this is beyond the FDA’s control. In a civil suit, a lawyer for the FDA acknowledged that this practice is legal but did not endorse it.

REFERENCES

• 1 – Caly et al. (2020) The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Research.
• 2 – Popp et al. (2022) Ivermectin for preventing and treating COVID-19. Cochrane Database of Systematic Reviews.
• 3 – Naggie et al. (2022) Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial. Journal of the American Medical Association.
• 4 – Naggie et al. (2023) Effect of Higher-Dose Ivermectin for 6 Days vs Placebo on Time to Sustained Recovery in Outpatients With COVID-19: A Randomized Clinical Trial. Journal of the American Medical Association.
• 5 – Barnett et al. (2022) Association of County-Level Prescriptions for Hydroxychloroquine and Ivermectin With County-Level Political Voting Patterns in the 2020 US Presidential Election. JAMA Internal Medicine.
• 6 – Temple et al (2021) Toxic Effects from Ivermectin Use Associated with Prevention and Treatment of Covid-19. New England Journal of Medicine.