The use of any treatment for COVID-19 that is not approved or cleared by the FDA, unless it is part of a clinical trial, can be very dangerous and cause serious harm, says a document issued by the Food and Drug Administration (FDA).FDA(see the following table).
This is the case of Ivermectin, whose overdose to mistakenly treat COVID-19, joins the crisis caused by hospitals overwhelmed with new cases and a high vaccine reluctance to stop the pandemic.
Inappropriate and dangerous use of this drug designed for use in animals has been detected in various parts of the country. Given the number of deaths that have occurred from the disease, it's perhaps not surprising that some consumers are mistakenly seeking unconventional, unapproved treatments, but, "while this is understandable, use caution," the FDA says.
"The FDA's job is to carefully evaluate the scientific data on a drug to make sure it is safe and effective for a given use, and then decide whether or not to approve it. He noted that there is growing interest in Ivermectin to treat humans for COVID-19. However, this drug is used in the U.S. to treat or prevent parasites in animals.
In response, the FDA has received multiple reports of patients requiring medical attention and being hospitalized after self-medicating with ivermectin intended for horses.
What you should know about Ivermectin and COVID-19
Ivermectin has not been approved by the FDA to treat or prevent COVID-19 in humans. It is approved in very specific doses for some parasitic worms, and topical formulations - on the skin - are available for lice and skin conditions such as rosacea. Ivermectin is not an antiviral - a drug to treat viruses.
Taking large doses of this drug is dangerous and can cause serious harm, the FDA said. However, it said, if you have a prescription for Ivermectin for an agency-approved use, it must be obtained from a legitimate source and taken exactly as prescribed.
"Never use drugs intended for animals on humans: the preparations are very different."
What is Ivermectin and how is it used?
Ivermectin tablets are approved by the FDA to treat people with strongyloidiasis and intestinal onchocerciasis, two conditions caused by parasitic worms. In addition, some topical forms of ivermectin are approved to treat external parasites such as lice and for skin conditions such as rosacea.
Some formulations of Ivermectin are used in animals to prevent heartworm disease and certain internal and external parasites. It is important to note that these products are different from those used for people, and are safe when used as prescribed, only in animals.
When can Ivermectin be dangerous to use?
The FDA has not reviewed data supporting the use of ivermectin in patients with COVID-19 to treat or prevent disease caused by SARS-CoV-2 virus. Some initial research is underway, but the agency has not approved the drug for this use.
"There is a lot of misinformation circulating about this, and you may have heard that you can take large doses of ivermectin. This is false," the FDA said.
Even approved levels of ivermectin can interact with other medications, such as blood thinners. Overdose is also possible, which can cause nausea, vomiting, diarrhea, hypotension (low blood pressure), allergic reactions (itching and hives), dizziness, ataxia (balance problems), seizures, coma, and even death.
Ivermectin products for animals are different from those designed for people. For one thing, animal medicines are usually highly concentrated because they're used for large animals like horses and cows, which can weigh a ton or more.
In addition, the FDA reviews drugs not only for the safety and efficacy of the active ingredients, but also for the inactive ingredients.
Many of the inactive ingredients found in animal products are not evaluated for use in people, or are included in a much larger amount. In some cases, we do not know how these inactive ingredients will affect the absorption of Ivermectin in the human body.
In the meantime, effective ways to reduce the spread of COVID-19 remain: wear a facemask in public or poorly ventilated places, stay at least 6 feet away from others who don't live with you, wash your hands frequently, and avoid crowded places. And of course, get vaccinated.
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