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FDA did not change position on ivermectin for Covid-19

FDA did not change position on ivermectin for Covid-19 - Featured image

Author(s): Marisha GOLDHAMER / AFP USA

The US Food and Drug Administration (FDA) has not “endorsed” the use of ivermectin to treat or prevent Covid-19, despite such claims on social media. The posts misrepresent the position of the agency, which has said clinical trials failed to show the drug is safe and effective against the coronavirus.

“The FDA has now endorsed treating COVID with Ivermectin!” says Erin Elizabeth, an alternative health blogger, in an August 12, 2023 post on Twitter, which is being rebranded as “X.”

The Center for Countering Digital Hate identified Elizabeth as one of the top spreaders of vaccine disinformation in 2021 (archived here).

Her post includes a video in which Fox Business host Maria Bartiromo speaks with Republican Senator Ron Johnson of Wisconsin, who claims ivermectin “was a Nobel Prize-winning medicine that could have saved hundreds of thousands of lives” (archived here).

Charlie Kirk, an American conservative activist who has previously spread misinformation, also promoted the clip.

“The FDA has blood on its hands,” he said in an August 11 X post. “How many Americans senselessly died because Big Medicine called this cheap, readily available Nobel Prize winning medicine horse paste?”

Screenshot of a post on Twitter, which is being rebranded as “X,” taken August 21, 2023
Screenshot of a post on Twitter, which is being rebranded as “X,” taken August 22, 2023

Similar posts circulated on Facebook and Instagram, as well as in articles from Zero Hedge and The Epoch Timeswebsites AFP has fact-checked in the past. The claims also spread in French, Spanish, German, Dutch, Croatian and Serbian, the latest in a series of misleading posts about ivermectin.

The drug is approved in the United States for use in animals and to treat humans suffering from conditions caused by parasitic worms, as well as head lice and rosacea. But the FDA has never authorized or recommended its use for Covid-19.

FDA lawyer statement

The claims shared online are based on a statement made during oral arguments in a case brought by three doctors who say they were “harmed” by the FDA in their efforts to treat patients.

Specifically, the court filing (archived here) argues the FDA overstepped by “repeatedly directing the public — including health professionals, professional organizations, and patients — not to use ivermectin for Covid-19.”

In response, Ashley Cheung Honold, a Justice Department lawyer representing the FDA, said during an August 8 hearing that the regulatory agency “explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat Covid” (archived here).

Asked about the testimony, the FDA directed AFP to an August 16 thread on X in which it said: “Health care professionals generally may choose to prescribe an approved human drug for an unapproved use when they judge that the unapproved use is medically appropriate for an individual patient” (archived here).

However, the FDA reiterated that it has “not authorized or approved ivermectin” to prevent or treat Covid-19 — “nor has the agency stated that it is safe or effective for that use.”

In its previous online communications about the drug, the FDA left open the possibility of taking ivermectin off-label, saying: “If your health care provider writes you an ivermectin prescription, fill it through a legitimate source such as a pharmacy, and take it exactly as prescribed” (archived here).

In September 2021, the American Medical Association, American Pharmacists Association and American Society of Health-System Pharmacists said they “strongly oppose the ordering, prescribing, or dispensing of ivermectin to prevent or treat Covid-19 outside of a clinical trial” (archived here).

Responding to 2021 reports of patients who required medical attention after self-medicating with ivermectin intended for livestock, the FDA pointed to the risks of overdose, including “nausea, vomiting, diarrhea, hypotension (low blood pressure), allergic reactions (itching and hives), dizziness, ataxia (problems with balance), seizures, coma and even death.”

‘No scientific basis’

A 2020 study (archived here) found that ivermectin inhibits the replication of the coronavirus in vitro, spurring clinical trials around the world to determine if it should be used to treat or prevent Covid-19.

But guidance from the US National Institutes of Health updated in March 2023 recommends against it.

“The plasma concentrations necessary for the antiviral efficacy detected in vitro would require administration of doses up to 100-fold higher than those approved for use in humans,” the agency says (archived here).

Pharmaceutical company Merck, an ivermectin manufacturer, said in 2021 that it saw “no scientific basis for a potential therapeutic effect against Covid-19” (archived here). Studies back that up:

  • A clinical trial that enrolled 1,500 patients in the United States found that “among outpatients with mild to moderate Covid-19, treatment with ivermectin … compared with placebo, did not significantly improve time to recovery” (archived here).
  • Another US study gave patients a higher dosage of ivermectin and found those taking it had the same recovery time as those who received a placebo (archived here).
  • A review of multiple studies from around the world failed to find evidence of benefits to Covid-19 patients (archived here).

More of AFP’s reporting on misinformation about Covid-19 is available here.

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Originally published here.