FDA says there is no ivermectin for COVID, but it’s rare in Austin anyway
As the United States 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 anyway almost impossible to meet the growing demand for medicine.
Ivermectin, an antiparasitic agent whose demand rose 2,400% in August after some used it as an alternative treatment for symptoms of the coronavirus, has been the subject of much debate in recent weeks by medical professionals. and the public.
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The use of ivermectin as a COVID-19 treatment was popularized by Austin-based podcaster Joe Rogan, a vaccine skeptic who allegedly used the pest control drug after being diagnosed with the disease.
The drug is not approved by the FDA for COVID-19, and it should only be used to treat infections caused by certain parasitic worms and head lice and skin conditions like rosacea, according to health experts from the US. FDA and national Centers for Disease Control. and Prevention.
Clinical trials evaluating ivermectin tablets for the prevention or treatment of COVID-19 in humans are underway, according to the FDA.
But calls for ivermectin poisoning have increased 163%, according to data collected by the American Association of Poison Control Centers and reported by USA TODAY.
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“The FDA has not licensed or approved ivermectin for the treatment or prevention of COVID-19 in humans or animals,” the FDA said in a statement posted on its website. “Ivermectin has not been shown to be safe or effective for these indications (symptoms).”
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The FDA on its website states that ivermectin products for animals are different from ivermectin for humans. Ignoring this distinction could cause human users to take large doses of the medicine for horses and cows.
According to the FDA, many inactive ingredients in the animal form of ivermectin are not tested for use in humans. However, even ivermectin levels approved for humans can still cause nausea, vomiting, diarrhea, low blood pressure, allergic reactions, dizziness, balance problems, seizures, coma, and even fainting. dead if too much is taken.
Ivermectin rare in Austin
Aaron Williams, a pharmacist at Brodie Lane Pharmacy in South Austin, said Wednesday his team received about one request per day for ivermectin for human consumption, a decrease from about two requests per day last month.
Before the latest wave of coronavirus, fueled by the delta variant, Williams said it was rare to receive even a single prescription for ivermectin for human use.
âIt’s a rarely used drug,â Williams said. âI have always found it ironic that people say they didn’t want to be vaccinated because they didn’t want to be a guinea pig. And yet there have been more doses of COVID vaccines than there are. has had prescriptions for ivermectin in the past 10 years. ”
Pharmacist Matt Warnken of 38th Street Pharmacy in Central Austin said his team received roughly the same number of ivermectin requests as Brodie Lane Pharmacy. However, both pharmacists say filling the drug prescriptions has been difficult for two reasons.
One of the reasons is the lack of availability from wholesalers of the drug, according to Williams.
The second reason is that pharmacists find it difficult to verify prescriptions from doctors and practitioners.
Pharmacies receive mid-level practitioners, many of whom are from outside Texas, who need the supervision of a supervising physician when they submit a script for ivermectin. A call center phones and asks the pharmacist to fill the prescription, but pharmacists want to check with the supervising physicians first or at least verify that they are real.
âWe weren’t really able to fill the majority of the orders,â Williams said, adding that his pharmacy had no back orders. “What we often see is that when we poll these call centers for information on supervising physicians, they just cancel orders with us and call elsewhere.”
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 US statesman called Austin Compounding Pharmacy on Wednesday, but the person who answered the phone said she was too busy to speak due to the demand for ivermectin.
The pharmacy’s website, despite the lack of legitimate scientific confirmation, states that “taking ivermectin once a week will reduce your risk of infection and reduce the severity if you contract COVID-19.”
A KVUE-TV report this week stated that Austin Compounding Pharmacy received approximately 300 prescriptions for ivermectin per day.
However, Williams said the doses of ivermectin taken by people who think it will prevent or treat symptoms of the coronavirus are too high.
âParticularly at the dosage they use, it’s a little outside the dosage range that the FDA has approved for the indications being studied, which is always kind of a red flag,â Williams said.
âFor an off-label indication, once the dosage starts to push those upper limits and goes to something higher than the FDA-approved indications, you still have to be careful because we just don’t know what kind of. effects this will have since this has not been studied, âhe said.
The FDA agreed, saying, âThere’s a lot of misinformation around, and you may have heard that it’s okay to take high doses of ivermectin. It’s not acceptable.
The history of ivermectin
Despite national health leaders warning against the use of the drug, some social media users continue to support the use of ivermectin for COVID-19, citing that two discoverers of an ivermectin precursor, known as avermectin, won the 2015 Nobel Prize in Physiology and Medicine for the Treatment of Parasites, according to a report from USA TODAY.
In the late 1970s, a Merck researcher, parasitologist William Campbell, discovered that when mice infected with intestinal roundworms received the bacteria grown by biochemist Satoshi Omura, the parasites were effectively eliminated, according to the USA TODAY report. .
The key parasite-smothering ingredient, Campbell’s team found, 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 marketed the avermectin B1 derivative, ivermectin, for veterinary use.
In the 1980s, ivermectin was the world’s best-selling veterinary drug, according to USA TODAY. It was also at this time that potential human applications emerged.
Ivermectin, after extensive human testing, was first distributed in 1988 in countries affected by river blindness and another parasitic disease called lymphatic filariasis, caused by microscopic worms that invade the lymphatic system human.
The FDA approved ivermectin for human use as an antiparasitic drug in 1996 for the treatment of river blindness and strongyloidiasis, another parasitic infection that primarily infects animals but can affect humans, according to USA TODAY.
“The reason for the interest in ivermectin is that laboratory studies have shown that it can prevent viruses from multiplying in experimental environments – that is, in a Petri dish – and therefore people were hoping it would mean it could help treat COVID-19 in people too, “said Dr. Denise McCulloch, an infectious disease specialist at the University of Washington School of Medicine, in an email to USA TODAY.
âUnfortunately, the few high-quality studies that have been done to date do not demonstrate a beneficial effect of ivermectin when used in people with COVID-19,â she noted.
USA TODAY reporter Miriam Fauzia contributed to this report.