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One of the U.S. Food and Drug Administration&#;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.
There continues to be interest in a drug called ivermectin for the prevention or treatment of COVID-19 in humans. The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals.
For humans, ivermectin tablets are approved at specific doses to treat some parasitic worms, and there are topical (on the skin) formulations for head lice and skin conditions like rosacea. For animals, certain pour-on, injectable, paste, chewable, and &#;drench&#; ivermectin products are approved in the U.S. to treat or prevent parasites in animals.
The FDA has received multiple reports of patients who have required medical attention, including hospitalization, after self-medicating with ivermectin intended for animals.
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 in animals. It&#;s important to note that these products are different from the ones for people, and safe only when used in animals as labeled or as prescribed.
The FDA has not authorized or approved ivermectin for the treatment or prevention of COVID-19 in people or animals. The FDA has not determined that ivermectin is safe or effective for these indications (uses).
You may have heard that it&#;s okay to take large doses of ivermectin. Taking large doses of ivermectin can be dangerous.
Even doses 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, diarrhea, hypotension (low blood pressure), allergic reactions (itching and hives), dizziness, ataxia (problems with balance), seizures, coma and even death.
Current CDC guidance provides practical recommendations and information to help people lower risk from a range of common respiratory viral illnesses, including COVID-19.
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.
Ivermectin, an anti-parasitic drug often used in animals, has seen a steep rise in prescriptions as patients seek out alternative treatments for COVID-19. If a patient insists on this drug, infectious disease expert John Farley, MD, MPH, has the following advice for doctors: tell that patient to get vaccinated.
Explore top articles, videos, research highlights and more from the AMA&#;your source for clear, evidence-based news and guidance during the pandemic.
See the Latest Updates&#;If they're infected and qualify for monoclonal antibodies, they should be treated,&#; said Dr. Farley, director of the Food and Drug Administration (FDA) Office of Infectious Diseases in the Center for Drug Evaluation and Research.
The FDA has not approved or authorized ivermectin drug for COVID-19, and other federal agencies have warned against its use for preventing and treating the virus. In an episode of &#;AMA COVID-19 Update,&#; Dr. Farley discussed the drug&#;s safety concerns, its potential side effects and the important role of physicians in guiding the unvaccinated to better choices.
The AMA has joined other organizations in opposing the ordering, prescribing or dispensing of ivermectin to prevent or treat COVID-19 outside of a clinical trial.
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Little evidence supporting ivermectin
Results from small clinical trials touting its benefits has fueled patient interest. However, many of these trials took place in other countries, without any FDA oversight.
&#;We actually have no way of confirming whether the results reported in those trials are real or not,&#; Dr. Farley said. Other clinical trials have shown no benefit for ivermectin.
People who choose ivermectin over vaccination could be making a tragic mistake, he cautioned. Physicians should leverage their status as a trusted source to guide patients to another solution.
&#;If they're sitting in your exam room, even if they're pushing back and giving you a hard time, they trust your recommendations. I would encourage them to get vaccinated for prevention,&#; said Dr. Farley. Any patient with COVID-19 who is in a high-risk group should get treated with a monoclonal antibody to help stay out of the hospital.
Not always intended for humans
While some ivermectin products are meant for humans, others are specifically formulated for animal or veterinary use. The problem with humans taking drugs intended for animals is those drug formulations often contain ingredients that would be safe for a horse or a cow but not for a human, said Dr. Farley.
The FDA has identified multiple reports of patients who tried to self-medicate with ivermectin products intended for livestock and were subsequently hospitalized.
Some oral formulations have been approved by FDA to treat people with parasitic worms. &#;It&#;s a valuable drug, particularly in international settings,&#; Dr. Farley said. Generally, it&#;s given as a single-dose treatment and repeated only at recommended intervals.
&#;We actually don't have data about the safety of taking ivermectin every day for a long period of time,&#; he added.
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Subscribe NowThe drug can cause stomach problems, skin rash and itching, and nervous system problems such as dizziness and tremors.
COVID-19 treatment trials underway
Everyone wants a pill to treat COVID-19. Clinical trials are underway to examine by-mouth drugs to treat the deadly illness. &#;That's a very high priority for the government. We need to wait for the results of those trials to know if one of those treatments shows benefit,&#; said Dr. Farley.
If the trial data is convincing enough, the federal government will work as hard as it can to make that treatment available and provide physicians information they need to maximize benefit and minimize risk, he emphasized.
Patients infected with COVID-19 and at low risk for disease progression who insist on ivermectin should join a clinical trial. This way, they&#;d get treated with a safe formulation of the drug, at the right dose, said Dr. Farley. Patients can find clinical trials available with contact information at clinicaltrials.gov.
Get the latest news on the COVID-19 pandemic, vaccines and variants, and more reliable information directly from experts and physician leaders with the &#;AMA COVID-19 Update.&#;
You can catch every episode by subscribing to the AMA&#;s YouTube channel or the audio-only podcast version.
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