FDA Warning Letter Issued to Website Purveying Ivermectin Pills for Covid-19
21 Mar 2023
Emergency Use AuthorizationClinical Result
A website that markets ivermectin as a Covid-19 treatment has run afoul of the FDA. The agency issued a warning letter notifying the site that it is selling unapproved and misbranded products over the internet to consumers in the U.S.
The warning letter, dated March 16, was posted by the FDA on Tuesday. According to the agency, the website ivermectin4covid.com stated: “Ivermectin (Iverheal 12) is an antiparasitic, and also an antiviral drug manufactured by Healing Pharma. It is used to kill the parasites in the body. It is also useful in Covid 19 care.”
Iverheal12 is a generic version of ivermectin manufactured by Healing Pharma, a Mumbai, India-based generic medicines company. The drug is a 12 mg dose that Healing Pharma offers in packages of 10 tablets per box. The language the FDA quoted from ivermectin4covid’s site is a word-for-word restatement of language in Healing Pharma’s description of the product.
The FDA letter states that that while approved versions of ivermectin are available in the U.S., the Iverheal 12 mg product from Healing Pharma is not one of them. The agency also said approved versions of ivermectin are for treating parasitic infections, and they are available only by prescription.
“In addition, ivermectin has not been approved by FDA for use in the prevention, diagnosis, treatment, mitigation, or cure of COVID-19,” the warning letter stated.
The letter tells the company to review its website, labels, and promotional materials to ensure that they do not misleadingly represent products as safe and effective for uses that are not approved by the FDA. Furthermore, the company is directed to respond to the FDA within 48 hours with an email describing the steps it has taken to address violations and to prevent their recurrence.
The ivermectin4covid website now shows a single page stating it has been temporarily suspended according to guidance by the FDA. An archived version shows it was also selling hydroxychloroquine in packages of 100 tablets per box. According to a check of the website on hostingchecker.com, ivermectin4covid.com is hosted in Singapore by DigitalOcean, a New York-based company that operates data centers across the world.
Ivermectin traces its origins to Japan, where scientists isolated a microorganism from a soil sample in the 1970s, according to a 2011 paper published in Proceedings of the Japan Academy, Series B. This microorganism was found to have properties useful in killing internal and external parasites. A partnership between Kitasato Institute in Japan and pharmaceutical giant Merck led to the development of broad-spectrum antiparasitic agents called avermectins.
Ivermectin is a semisynthetic antiparasitic derived from avermectin and made for oral dosing. Merck brought the product to market under the name Stromectal. Though patents on this product have long expired and generic versions are widely available, Merck still sells Stromectal. In 2021, during the height of the pandemic, the company reiterated that preclinical and clinical research found no scientific basis for using ivermectin to treat Covid-19.
Well-controlled scientific studies continue to show that ivermectin does not help in the treatment of Covid-19. A randomized, placebo-controlled study that enrolled more than 1,500 U.S. patients when the delta and omicron variants were dominant found that ivermectin did not significantly improve the time to recovery from mild-to-moderate Covid-19. The peer-reviewed results were published last October in the Journal of the American Medical Association.
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