No, FDA did not 'quietly approve' ivermectin as COVID-19 treatment | Fact check

Joedy McCreary, USA TODAY
·4 min read
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The claim: The FDA quietly approved ivermectin to treat COVID-19

An Aug. 12 Facebook post (direct link, archive link) indicates there's news about ivermectin, an anti-parasitic drug that experts have long said is ineffective as a COVID-19 treatment.

“Remember the FDA ‘horse de-wormer’ narrative discrediting a proven life-saving drug to push an ineffective Big Pharma unproven shot?” the post reads. “The FDA just quietly approved it.”

It was shared more than 50 times in four days. Similar claims were made on the Fox Business Network and in an Instagram post that accumulated more than 2,000 likes.

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Our rating: False

The FDA has not approved ivermectin as a COVID-19 treatment in humans, an agency spokesperson said. The claim distorts a Justice Department attorney’s statement in court that the FDA does not stop doctors from prescribing the drug off-label.

Claim misrepresents statement in court

The FDA has not changed its position on ivermectin, and experts maintain it is not an effective treatment for COVID-19.

The agency has not authorized or approved the drug for use in preventing or treating COVID-19 in people, FDA spokesperson Chanapa Tantibanchachai said in an email to USA TODAY.

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Dr. Adrian Hernandez, the director of the Duke Clinical Research Institute, led trials in 2022 to determine whether taking it provides any benefits for a person with COVID-19.

“There was no effect in improving patient symptoms with COVID or preventing them from being hospitalized,” Hernandez said.

The claim traces back to early August in the 5th U.S. Circuit Court of Appeals in New Orleans.

Justice Department attorney Ashley Honold told judges the FDA’s public warnings about self-medicating with ivermectin do not bar doctors from prescribing it off-label for COVID-19 or any other disease.

Social media users wrongly took that to mean the agency gave the drug its approval. That has not happened.

“Physicians often have – not always, but often have – freedom for prescribing different medications for people,” Hernandez said. “But that does not mean it’s an indication.”

In medical terms, an indication is a medical condition for which a specific medicine is used.

For years, claims about ivermectin as a COVID-19 treatment have circulated on social media, particularly among those who are not vaccinated.

The courtroom statement came as part of a request by three doctors who want the appeals court to reinstate their lawsuit against the FDA, the Department of Health and Human Services and the leaders of those agencies. Those doctors prescribed the drug off-label to thousands of COVID-19 patients and argue the FDA overstepped its authority by issuing its advisories.

That lawsuit was filed in June 2022. A judge dismissed it in December.

The Facebook post includes a link to a blog entry about the court hearing that does not back up the claim. While it says the FDA recognizes the authority of doctors to prescribe ivermectin to treat COVID-19, the article does not say anything about the agency approving it, quietly or otherwise.

The social media user who made the post declined to provide evidence to support the claim in an email to USA TODAY.

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This article originally appeared on USA TODAY: Ivermectin still not FDA-approved as COVID-19 remedy | Fact check