You may have heard about a drug called ivermectin, which some people have taken off-label in hopes of treating their COVID-19 infection. It’s the latest example of a medication being used to treat COVID-19 without clinical evidence to support its safety and effectiveness.
Poison control centers have recently seen a five-fold increase in calls from people who have experienced adverse effects after self-treating COVID-19 with ivermectin.
It is critical to know that ivermectin can lead to serious harm and cause severe illness or even death when misused.
What is “off-label” use?
Ivermectin tablets are approved by the U.S Food and Drug Administration (FDA) to treat two conditions caused by parasitic worms: intestinal strongyloidiasis and onchocerciasis. In addition, some topical forms have been approved to treat external parasites, such as head lice, and for certain skin conditions, like rosacea.
This drug is not authorized or approved by the FDA for the prevention or treatment of COVID-19, because researchers have not found evidence of its safety or effectiveness for that.
Thus, the use of ivermectin as a COVID-19 medication would be considered an off-label use. But what does that mean?
When a medication is approved by the FDA, the approval is for the medication to be used to treat a specific condition or disease. A health care provider might suggest off-label use of a medication if other medications have not been effective for the patient or no other medications are available.
When off-label use is considered, the patient and their health care provider would discuss the risks and benefits and make a decision together. Without medical oversight, people can have a bad reaction to the drug, they could take a dangerously high dose or the drug could interact negatively with their other medicines.
The veterinary formulation of ivermectin
With ivermectin, off-label use is not the only recent consideration. Some people, eager to try the medication without consulting a doctor, have purchased a formulation intended for horses. Ivermectin as a horse medicine is used by veterinarians to prevent and treat parasitic infections – it’s a dewormer.
Veterinary products often contain high concentrations of a drug, which may lead to overdose in humans. In addition, veterinary medications may have inactive ingredients that have not been evaluated for use in humans.
When taken by a human, the veterinary formulation of ivermectin can cause nausea, vomiting and diarrhea. In larger doses, it may cause low blood pressure, confusion, hallucinations, seizure, coma and death.
When is off-label use safe?
The key to off-label use of any medication is that you would partner with your health care provider to evaluate your options. Not only is your provider a medical expert, they are aware of your overall health and any risk factors that could affect your safety. Without this guidance, any off-label drug use can be dangerous.
Before you consider taking any medication, please talk to your health care provider. And for your own health and safety, only obtain medications with a prescription written by your provider specifically for you.
Learn more about COVID-19 and the COVID-19 vaccine.