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FDA warns against taking ivermectin for COVID, but Austin pharmacists say drug is scarce anyway

Heather Osbourne
Austin American-Statesman

As the U.S. Food and Drug Administration continues to warn against the use of ivermectin as an experimental treatment for coronavirus symptoms, a handful of Austin-area pharmacists say supply issues make it nearly impossible to fill the increased demand for the drug anyway.

Ivermectin, an anti-parasitic agent that increased in demand by 2,400% in August after some used it as an alternative treatment for coronavirus symptoms, has been the topic of much debate in recent weeks by health professionals and the public. 

Ivermectin's use as a COVID-19 treatment was popularized by Austin-based podcaster Joe Rogan, a vaccine skeptic who reportedly used the anti-parasitic drug after being diagnosed with the disease.

The drug is not approved by the FDA for COVID-19, and it only should be used to treat infections caused by some parasitic worms and head lice and skin conditions like rosacea, according to health experts from the FDA and the national Centers for Disease Control and Prevention. 

Ivermectin poisoning calls have increased by 163%, according to the American Association of Poison Control Centers.

Clinical trials assessing ivermectin tablets for the prevention or treatment of COVID-19 in people are ongoing, according to the FDA. 

But ivermectin poisoning calls have increased by 163%, according to data collected by the American Association of Poison Control Centers and reported by USA TODAY. 

More:Fact check: Precursor to ivermectin did win Nobel Prize, but it's not a proven COVID-19 treatment

"The FDA has not authorized or approved ivermectin for the treatment or prevention of COVID-19 in people or animals," the FDA said in a statement on its website. "Ivermectin has not been shown to be safe or effective for these indications (symptoms)."

More:Fewer patients but critical care still strained as Austin struggles to improve in COVID-19 hospital data

The FDA on its website clarifies that ivermectin products for animals are different from ivermectin for people. Ignoring this distinction might cause human users to take large doses of the drug intended for horses and cows. 

Many of the inactive ingredients in the animal form of ivermectin are not tested for use in people, according to the FDA. However, even the levels of ivermectin approved for humans can still cause nausea, vomiting, diarrhea, low blood pressure, allergic reactions, dizziness, problems with balance, seizures, coma and even death if too much is taken. 

Ivermectin scarce in Austin

Aaron Williams, a pharmacist at Brodie Lane Pharmacy in South Austin, said Wednesday that his team has been receiving about one request each day for ivermectin for human consumption, a decrease from about two requests per day last month. 

Before the most recent coronavirus surge, fueled by the delta variant, Williams said it was uncommon to receive even one prescription for human-use ivermectin. 

"It's a rarely used drug," Williams said. "I always found it ironic that people said they didn't want to get vaccinated because they didn't want to be a guinea pig. And, yet, there have been more doses given of COVID vaccines than there has been prescriptions for ivermectin in the last 10 years." 

Pharmacist Matt Warnken of 38th Street Pharmacy in Central Austin said his team has experienced about the same number of requests for ivermectin as Brodie Lane Pharmacy. However, both pharmacists say filling the drug prescriptions has been difficult for two reasons.

More:Fact-check: Did India's COVID cases plummet after hydroxychloroquine, ivermectin use?

One reason is the lack of availability from wholesalers of the drug, according to Williams.

The second reason is that pharmacists are struggling to verify prescription orders from doctors and practitioners.

Pharmacies are hearing from midlevel practitioners, many from outside of Texas, who need oversight by a supervising physician when they send a script in for ivermectin. A call center phones and asks the pharmacist to fill the prescription, but the pharmacists want to double-check with the supervising doctors first or at least verify that they’re real.

"We haven't really been able to fill the majority of the orders," Williams said, adding that his pharmacy doesn't have any orders pending. "Kind of what we see a lot of times is, as we question these call centers for information about the supervising physicians, they just cancel the orders with us and call somewhere else." 

Even though the FDA is strictly against the use of ivermectin to treat or prevent symptoms of COVID-19, some Austin-area pharmacies such as Austin Compounding Pharmacy are promoting it. 

The American-Statesman called Austin Compounding Pharmacy on Wednesday, but the person who answered the phone said they were too busy to talk because of the demand for ivermectin.

The pharmacy's website, despite a lack of legitimate scientific confirmation, says "taking ivermectin once a week will decrease your risk of infection and reduce the severity if you do contract COVID-19." 

A report from KVUE-TV this week said Austin Compounding Pharmacy has received about 300 prescriptions for ivermectin per day.

However, Williams said the doses of ivermectin being taken by people who believe it will prevent or treat coronavirus symptoms are too high. 

"Especially at the dosing that they're using, it's kind of outside the range of dosing that the FDA approved for studied indications, which is always kind of a red flag," Williams said.

"For an off-label indication, once the dosing starts to push those upper limits and goes to anything higher than FDA-approved indications, it's always something to be cautious of because we just don't know what kind of effects that will have since it hasn't been studied," he said.

The FDA agreed, saying: "there’s a lot of misinformation around, and you may have heard that it’s OK to take large doses of ivermectin. It is not OK."

The history of ivermectin

Despite national health leaders warning against the drug's use, some social media users continue to support the use of ivermectin for COVID-19, citing that two discoverers of a precursor of ivermectin, known as avermectin, won the 2015 Nobel Prize in physiology and medicine for the treatment of parasites, according to a USA TODAY report. 

In the late 1970s, a Merck researcher, parasitologist William Campbell, found that when mice infected with intestinal roundworms were given the bacteria cultivated by biochemist Satoshi Omura, the parasites were effectively wiped out, the USA TODAY report said. 

The key ingredient stifling the parasites, Campbell's team discovered, was a chemical they named avermectin, which turned out to be a mixture of eight closely related compounds, USA TODAY reporters found. In 1981, after clinical trials in animals, Merck commercialized the Avermectin B1 derivative, ivermectin, for veterinary use. 

By the 1980s, ivermectin was the top-selling veterinary drug in the world, according to USA TODAY. This is also when potential human applications emerged. 

Ivermectin, after many human trials, was first distributed in 1988 to countries affected by river blindness and another parasitic disease called lymphatic filariasis, which is caused by microscopic worms that invade the human lymph system.

The FDA approved ivermectin for human use as an anti-parasitic drug in 1996 for treatment of river blindness and strongyloidiasis, another parasitic infection that mostly infects animals but can affect humans, according to USA TODAY.

"The reason for the interest in ivermectin is that studies in the lab have shown it can block viruses from multiplying in experimental settings – i.e., in a petri dish – and so people hoped this would mean it could help treat COVID-19 in people too," Dr. Denise McCulloch, an infectious disease specialist with the University of Washington's School of Medicine, said in an email to USA TODAY.

"Unfortunately, the few high-quality studies that have been done to date do not demonstrate a beneficial effect of ivermectin when it is used in people with COVID-19," she noted.

USA TODAY staff reporter Miriam Fauzia contributed to this report.