The FDA says it has not approved Ivermectin for use in treating or preventing COVID in humans. It's actually intended for horses.
Despite the warning, the FDA said it's had multiple reports of patients who have been hospitalized after taking Ivermectin.
In fact, the FDA took to Twitter over the weekend, urging people to stay away from the drug.
"You are not a horse. You are not a cow. Seriously, y'all. Stop it," read the tweet.
You are not a horse. You are not a cow. Seriously, y'all. Stop it. https://t.co/TWb75xYEY4— U.S. FDA (@US_FDA) August 21, 2021
According to the FDA's website, Ivermectin tablets are approved at very specific doses for some parasitic worms, and there are topical (on the skin) formulations for head lice and skin conditions like rosacea.
The FDA says Ivermectin is not an anti-viral (a drug for treating viruses).
Meanwhile, in the Houston area, Ivermectin sales have gone up, according to some pet store owners.
Trace Menchaca, who owns Modern Pet Foods in northwest Harris County, said she's been selling a lot more Ivermectin lately.
"We typically sell ten of those maybe a month, but in the past month, we've probably sold 50 to 100 each. We've seen a huge uptick. The sales have increased," she said.
Given that huge increase, Menchaca suspects it could be related to the misinformation circulation about Ivermectin and coronavirus.
"We don't know that's what they're using it for. Certainly, that's what we suspect," said Menchaca.
However, the product sold in her store is only designed to treat animals and should never be used by humans.
"The concentration can be much higher for animal product and medication compared to human medication," explained Dr. Jill Weatherhead, an assistant professor of infectious diseases and tropical medicine at the Baylor College of Medicine. "Additionally, there can be other additives to the medication that are used in animal meds compared to human meds."
To be clear, there is a dosage of Ivermectin for human consumption. It's a different dosage and it's designed to treat parasitic infection but it's not approved for use to treat COVID.
"At those doses and durations, it is a very safe and tolerable medication. The problem is when you start treating off label without any scientific evidence of benefit," said Weatherhead.
Despite the FDA warning, one father said his son was prescribed Ivermectin for treatment.
In College Station, Gary Lynch said his 15-year-old son, Jordan, tested positive for COVID. Jordan had mild coronavirus symptoms.
The doctor prescribed the medicine, according to Lynch. That's when he said Jordan took one pill and later became sick to his stomach.
His family then then called a relative, who happens to be a doctor.
"She told us not to give it to him because it's not FDA approved," said Lynch.
The father is sharing his story in hopes that parents and adults make sure they're asking about the prescriptions and treatments they're receiving.
We did reach out to the medical provider that Lynch said prescribed Ivermectin. They followed up the next day, sharing NIH's published guidelines for why Ivermectin may be prescribed for some patients with COVID-19, and providing the following statement.
"In short, physicians may prescribe it for some patients out of a desire to do everything that can be done to fight this devastating disease. We don't have time to wait months and years for efficacy studies (paralysis by analysis), people are dying now, and we need to do everything we can that is reasonably safe to do. Ivermectin is reasonably safe when treatment is supervised by a medical professional, no one disputes that.
Also, lacking FDA approval alone is not a reason to forgo using or trying a specific treatment. Many, many medications are used "off-label" for non-FDA approved indications as the standard of care. It's not feasible to seek FDA approval for every indication a drug may be beneficial for and in some unprecedented cases, such as during a global pandemic, there may not be time to wait for one.
Furthermore, it should be considered that Remdesivir, monoclonal antibodies, and COVID-19 vaccines were all used and recommended nearly universally before or without formal FDA approval. Lack of FDA approval alone is not a good reason not to use a specific medication despite what Jordan Lynch's doctor says. In fact, I'd be willing to bet that he/she actually does it all the time.
Bottom line, is it safe? Yes. Does it help? We don't know for sure, but there is some evidence that it does. If your life, or the life of a loved one, potentially depended on it, would you want your doctor to allow you, or your loved one, to try it under their guidance and supervision? Of course.
It's disheartening that one of our patients', who we work so hard and care so much for, father has the misguided perception that we mismanaged their son's care by giving him medication for worms. It's also disheartening to have the media change your status from 2020 hero to 2021 villain. As for us front-liners, we'll just keep our heads down and keep doing our best to fight COVID."
Thanks for considering,
John Davidhizar, MD
NOTE: Trace Menchaca is a family member of an ABC13 staff member.
For updates on this report, follow ABC13 reporter Marla Carter on Facebook,Twitter and Instagram.