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VERIFY: Here’s why Ivermectin is not authorized to treat COVID-19 right now

Our VERIFY team helps you separate fact from fiction.

AUSTIN, Texas —

Question

“Can you provide verification of the use and effectiveness of Ivermectin as a treatment for COVID?”

Result

  • It is being used in clinical studies.
  • It is not FDA-approved.
  • It does not have FDA emergency use authorization (EUA) for COVID-19 treatment in the U.S.
  • Doctors are allowed to prescribe it for COVID-19 treatment.

Sources

Process

Ivermectin is an antiparasitic treatment used to treat things like scabies.

Merck, the drug manufacturer, shows on its website:

“Ivermectin is approved in the United States under the brand name STROMECTOL. STROMECTOL is indicated for the treatment of intestinal (i.e., nondisseminated) strongyloidiasis due to the nematode parasite Strongyloides stercoralis and for the treatment of onchocerciasis due to the nematode parasite Onchocerca volvulus. STROMECTOL has no activity against adult Onchocerca volvulus parasites.”

The FDA adds, “some topical (on the skin) forms of ivermectin are approved to treat external parasites like head lice and for skin conditions such as rosacea.”

We submitted the VERIFY viewer question to FDA, WHO, Merck and Dr. F. Perry Wilson, MD, MSCE.

Here is the full FDA Response:

“Generally the FDA does not comment on specific studies, but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.

Ivermectin is an antiparasitic therapy that is approved by the FDA to treat people with intestinal strongyloidiasis and onchocerciasis. FDA-approved products may be prescribed by physicians for unapproved uses if they determine it is appropriate for treating their patients, including during COVID-19. At this time, the safety and efficacy of ivermectin for the prevention or treatment of COVID-19 has not been established. Information on clinical trials of ivermectin in COVID-19 can be accessed at https://www.clinicaltrials.gov/."

Additional Information from the FDA:

  • FAQ: COVID-19 and Ivermectin Intended for Animals

  • We note that FDA generally does not publish clinical treatment guidelines. You may wish to contact the NIH regarding COVID-19 treatment recommendations and their evolution over the course of the pandemic.

  • You can search COVID-19 treatments that have been given an Emergency Use Authorization here.

Here is the full WHO response:

“Please see this link to the Therapeutics and COVID-19: living guideline (who.int), which contains the Organization’s most up-to-date recommendations for the use of therapeutics in the treatment of COVID-19.

The current evidence on the use of ivermectin to treat COVID-19 patients is inconclusive. Until more data is available, WHO recommends that the drug only be used to treat COVID-19 within clinical trials. This applies to patients with any disease severity. 

Ivermectin is a broad spectrum antiparasitic agent, included in WHO essential medicines list for several parasitic diseases. The drug should continue to be used for its intended purposes.”

Here is the full Merck response:

“As our company has already indicated, company scientists are carefully examining the findings of available and emerging studies of ivermectin for the treatment of COVID-19 for evidence of efficacy and safety and continue to engage with the external scientific community regarding ongoing research. 

It is important to note that based on our review of available data, our analysis has identified:

  • No scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies;  

  • Significant limitations in evidence for clinical activity or clinical efficacy in patients with COVID-19 disease, rendering existing data inconclusive, and 

  • A lack of safety data in the majority of studies.

We continue to believe that the evidence available does not support the efficacious and safe use of ivermectin beyond the doses and populations indicated in the regulatory agency-approved prescribing information, including as a treatment for COVID-19. This is aligned with the positions of the U.S. Food and Drug Administration, European Medicines Agency and World Health Organization."

Merk also recommended the video, “Ivermectin for COVID: How Do We Know What to Believe?”

“There is a chance that there might be some modest effect that with a large enough trial you may be able to detect. But as a game-changer, as a silver bullet, the evidence is looking fairly strongly that it is not the case for this particular drug,” Wilson said.

“If ivermectin truly cured COVID, for example in the vast majority of people, all of the studies would detect that. They’re not seeing that. So, we know it’s not that kind of miracle pill,” Wilson said.

If you have a story for our VERIFY team, email verify@kvue.com

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