A consumer update from the U.S Food and Drug Administration
COVID-19: We’ve been living with it for what sometimes seems like forever. Given the number of deaths that have occurred from the disease, it’s perhaps not surprising that some consumers are turning to drugs not approved or authorized by the Food and Drug Administration (FDA).
One of the FDA’s jobs is to carefully evaluate the scientific data on a drug to be sure that it is both safe and effective for a particular use. In some instances, it can be highly dangerous to use a medicine for the prevention or treatment of COVID-19 that has not been approved by or has not received emergency-use authorization from the FDA.
There seems to be a growing interest in a drug called ivermectin for the prevention or treatment of COVID-19 in humans. Certain animal formulations of ivermectin, such as pour-on, injectable, paste, and "drench", are approved in the U.S. to treat or prevent parasites in animals. For humans, ivermectin tablets are approved at very specific doses to treat some parasitic worms, and there are topical (on the skin) formulations for head lice and skin conditions like rosacea.
However, the FDA has received multiple reports of patients who have required medical attention, including hospitalization, after self-medicating with ivermectin intended for livestock.
Here’s what you need to know about ivermectin
* The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals. Ivermectin is approved for human use to treat infections caused by some parasitic worms and head lice and skin conditions like rosacea.
* Currently available data do not show ivermectin is effective against COVID-19. Clinical trials assessing ivermectin tablets for the prevention or treatment of COVID-19 in people are ongoing.
* Taking large doses of ivermectin is dangerous.
* 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.
* Never use medications intended for animals on yourself or other people. Animal ivermectin products are very different from those approved for humans. Use of animal ivermectin for the prevention or treatment of COVID-19 in humans is dangerous.
What is ivermectin and how is it used?
Ivermectin tablets are approved by the FDA to treat people with intestinal strongyloidiasis and onchocerciasis, two conditions caused by parasitic worms. In addition, some topical forms of ivermectin are approved to treat external parasites like head lice and for skin conditions such as rosacea.
Some forms of animal ivermectin are approved to prevent heartworm disease and treat certain internal and external parasites. It’s important to note that these products are different from the ones for people, and safe only when used in animals as prescribed.
When can taking ivermectin be unsafe?
The FDA has not authorized or approved ivermectin for the treatment or prevention of COVID-19 in people or animals. Ivermectin has not been shown to be safe or effective for these indications.
There’s a lot of misinformation around, and you may have heard that it’s okay to take large doses of ivermectin. It is not okay.
Even the levels of ivermectin for approved human uses can interact with other medications, like blood-thinners. You can also overdose on ivermectin, which can cause nausea, vomiting, diarrhoea, hypotension (low blood pressure), allergic reactions (itching and hives), dizziness, ataxia (problems with balance), seizures, coma and even death.
Ivermectin products for animals are different from ivermectin products for people
For one thing, animal drugs are often highly concentrated because they are used for large animals like horses and cows, which weigh a lot more than we do – a ton or more. Such high doses can be highly toxic in humans. Moreover, the FDA not only reviews drugs for safety and effectiveness of the active ingredients, but also for the inactive ingredients. Many inactive ingredients found in products for animals aren’t evaluated for use in people. Or they are included in much greater quantity than those used in people. In some cases, we don’t know how those inactive ingredients will affect how ivermectin is absorbed in the human body.
Options for preventing and treating COVID-19
The most effective ways to limit the spread of COVID-19 include getting a COVID-19 vaccine when it is available to you and following current CDC guidance.
Talk to your health care provider about available COVID-19 vaccines and treatment options. Your provider can help determine the best option for you, based on your health history.
