FDA: Ivermectin Still Not Approved for COVID

The Food and Drug Administration posted on its social media accounts Friday that it still is not approving the drug ivermectin for the treatment or prevention of COVID-19.

“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 agency said in a post on X, formerly known as Twitter, Friday.

“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.”

According to the National Institute of Health, “Ivermectin is a Food and Drug Administration-approved antiparasitic drug used to treat several neglected tropical diseases, including onchocerciasis, helminthiases, and scabies. For these indications, ivermectin has been widely used and is generally well tolerated. Ivermectin is not approved by the FDA for the treatment of any viral infection.”

The NIH said that although the drug has been shown to inhibit the replication of COVID-19 cells, the dose required would be “100-fold” higher than the dosage approved for humans.

“Trials have failed to find a clinical benefit from the use of ivermectin for the treatment of COVID-19 in outpatients,” the NIH website said. “In TOGETHER, an adaptive platform trial conducted in Brazil, there was no apparent difference between the ivermectin and placebo arms for the primary outcome of risk of emergency department visits or hospitalization (14.7% vs. 16.4%).”

The Hill reported that several other health organizations, including the World Health Organization, the European Medicines Agency, the Infectious Diseases Society of America, and the NIH, advise against using the drug in COVID-19 cases.

The American Medical Association, the nation’s largest group of doctors, recommended physicians stop prescribing the medication to treat the virus, the report said.

According to the news outlet, more than 88,000 prescriptions for ivermectin were dispensed in just one month in 2021, compared to 3,600 human prescriptions in all of 2020.

The WHO said in March 2021 that ivermectin use in treating COVID-19 yielded inconclusive evidence of effectiveness.

The organization said that pooled data from 16 randomized controlled trials determined that there was “very low certainty” that ivermectin use reduced mortality, the need for medical ventilation, hospital admission, and clinical improvement in COVID-19 patients.