By Michael Kitchin
Note: The content in this article represents the opinions of the author and should not be construed as medical advice. Always seek the advice of your physician or other qualified healthcare provider with any questions you may have regarding a medical condition or treatment and before undertaking a new health care regimen, and never disregard professional medical advice or delay in seeking it
Since the beginning of the COVID-19 global pandemic, people have desperately sought out potential treatments, some evidence-based, others not. To date, the most dubious examples of supposed COVID-19 treatments have included hydrogen-peroxide humidifiers, silver-infused toothpaste, and ivermectin.
Despite the widespread domestic availability of a safe, effective, FDA-approved vaccination that protects against 96% of severe illness due to COVID-19 (70% in the case of the omicron variant), the unproven use of ivermectin to treat Coronavirus infections skyrocketed in late 2021. Per the FDA, (as of the date of publication) there is no available data to suggest that ivermectin is effective in treating COVID-19. While early studies in 2020 indicated that ivermectin may yield some benefit in the treatment of COVID-19, the quality and integrity of these clinical trials have since been called into question. Subsequent trials have shown no benefit to ivermectin use for COVID-19. Approved for the treatment of parasitic worms in humans, the drug has recently been used in several high-profile cases to “treat” COVID-19. With the meteoric rise in demand from primarily unvaccinated patients, well-meaning healthcare providers are prescribing ivermectin for off-label use in droves. Pre-pandemic there were approximately 3,600 ivermectin prescriptions filled a week. In mid-August of 2021, the CDC recorded 88,000 filled prescriptions in a week leading to a national shortage of ivermectin produced for human use.
In the face of this shortage or struggling to find a provider willing to prescribe the medication, some descended upon farming and livestock supply outlets in pursuit of over-the-counter veterinary ivermectin. The animal version of the drug is approved for use by the FDA only in horses, cattle, and other livestock to treat parasitic worms. Although the rigorous approval process for animal drugs is similar to that of human medications the approval processes are separate, and for good reason. Animal drugs are often mixed with compounds that make it easier to administer the medication to animals and these compounds can be unsafe for human consumption. Available animal dosing for ivermectin is frequently 10-15 times greater than human dosing and there are significant side effects of ivermectin overdose, including liver injury, kidney failure, seizures and potentially death. In September of 2021, New Mexico saw 14 hospitalizations from ivermectin toxicity. In addition to the potential consequences of taking ivermectin intended for human consumption when there is no demonstrated treatment benefit, by consuming veterinary ivermectin people are ignoring or accepting the added risks of ingesting medications manufactured and packaged for animals.
On August 21st 2021 the FDA released a consumer update admonishing the practice of taking ivermectin for COVID-19. State departments of health have put out public safety messaging through multiple outlets, but we continue to see an uptick in ivermectin-related calls to poison centers nationally. These early measures of a public awareness campaign come straight from the public health playbook. Trouble is, the largely unvaccinated Americans seeking ivermectin have already demonstrated their resistance to this type of messaging. It is for this reason that the FDA and regulators should take a more aggressive tact to prevent further strain on healthcare systems in areas with low vaccination rates.
The FDA is empowered to regulate both animal and human drugs through Chapter V of the 1938 Federal Food, Drug, and Cosmetic Act. The language of the act defines drugs for animals and humans separately, with language outlining the analogous approval processes. In both cases, drugs for which “adequate directions for safe and effective lay-use cannot be written” are designated as prescription medications. Conversely, over-the-counter (OTC) medications must have directions for use that enable a layperson to use the drugs safely and effectively by adhering to them. In the case of ivermectin, the human variety was determined to require a prescription, whereas the animal variety can be sold OTC.
This siloed approach has generally been appropriate, and the regulatory framework was crafted without anticipating the potential need for government intervention to stop people from taking animal medications.Unfortunately, the separation in regulation ties the hands of the FDA in this unique situation.
In general, the FDA will only facilitate the recall of a product if there is a safety issue, mislabeling, contamination, or deviations in strength or potency. Despite the new incidence of ivermectin toxicity from human ingestion of animal drugs, nothing about the safety profile of the drug has changed in the eyes of the FDA. Humans taking animal ivermectin are presumably aware that they are using the drug in a way counter to the directions. The drug isn’t harming animals from its misuse in humans. Hence the response of a public awareness campaign. The campaign aims to reinforce the instructions for safe use included in these products.
So what else can be done? Several farm supply stores have reportedly been requiring proof of animal ownership in the form of photographic evidence before selling ivermectin. It may be possible for local health departments to work with the stores that carry veterinary ivermectin to develop a standardized method to verify animal ownership prior to the sale of ivermectin. Such a measure relies on the goodwill and cooperation of business owners to help prevent shortages of life-saving animal medications and is ultimately non-enforceable.
Considering congressional action, American legislators and regulators alike rarely intervene directly when harm results from a product being misused by the consumer. Acetaminophen is frequently used in suicide attempts by taking more than directed, and the US has generally resisted effective measures to reduce risks such as limiting purchasable quantities. Despite the thousands of laundry detergent pod poisonings per year, regulators have only asked manufacturers to make them less appealing to children by redesigning them with no further threat of regulation or recall. In light of these examples, it is unlikely that we’ll see major regulatory or legislative movement to decrease animal ivermectin sales to consumers looking to use it on themselves.
Until action is taken to empower the FDA to restrict or reclassify over-the-counter the sale of animal drugs in cases of significant off-label public misuse, it is likely that injuries induced by ivermectin toxicity will continue. By passing a narrow amendment to the 1938 Federal Food, Drug and Cosmetic Act, further animal drug-induced injury can be minimized.