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Yes, is ivermectin a pharmaceutical? Understanding its approved uses and common misconceptions

4 min read

Discovered in the 1970s and developed from a soil microorganism, ivermectin has since become a versatile pharmaceutical with widespread applications in both human and veterinary medicine. The drug has a complex history and has been the subject of both Nobel Prize-winning research and modern misinformation campaigns.

Quick Summary

Ivermectin is a well-established pharmaceutical approved by the FDA for specific parasitic infections and skin conditions in humans and is also used in veterinary medicine. It is not approved for treating or preventing COVID-19.

Key Points

  • A Proven Pharmaceutical: Ivermectin is a legitimate and approved medication with a Nobel Prize-winning history for its development against parasitic diseases.

  • Not for COVID-19: The FDA and major health organizations do not recommend or authorize ivermectin for treating or preventing COVID-19, and large-scale trials have shown no benefit.

  • Specific Approved Uses: Ivermectin is FDA-approved for treating certain human parasitic infections, such as intestinal strongyloidiasis and onchocerciasis, and some skin conditions.

  • Dangerous Animal Formulations: Veterinary ivermectin is formulated differently and at much higher doses than human versions, making it dangerous and potentially toxic for human use.

  • Misinformation Alert: A significant amount of misinformation has circulated about ivermectin's use, particularly in relation to COVID-19, leading to public health risks.

  • Consult a Doctor: It is essential to only take ivermectin as prescribed by a healthcare professional for approved indications, not for unproven or self-diagnosed conditions.

  • Broader Research: While established as an antiparasitic, ivermectin is also being explored for potential anti-inflammatory, antiviral, and anticancer properties, though these uses are still under investigation.

In This Article

The Pharmaceutical Journey of Ivermectin

Ivermectin's status as a legitimate pharmaceutical is rooted in its discovery and development. The drug originated from a collaborative research effort between Merck and the Kitasato Institute in Japan, following the isolation of avermectin from the soil bacterium Streptomyces avermitilis in the 1970s. The semi-synthetic derivative, ivermectin, was developed and subsequently introduced for commercial use in veterinary medicine by Merck in 1981.

Following its success as an antiparasitic agent in animals, researchers began investigating its potential for human use. Clinical trials led to its approval for treating parasitic infections in humans in the late 1980s. The profound humanitarian impact of ivermectin, particularly in treating parasitic diseases like river blindness, was recognized with the Nobel Prize in Physiology or Medicine in 2015, awarded to its discoverers, William C. Campbell and Satoshi Ōmura. This journey from a soil sample to a Nobel Prize-winning medication firmly establishes ivermectin as a foundational pharmaceutical.

FDA-Approved Uses for Humans

While ivermectin's use became a subject of controversy during the COVID-19 pandemic, its specific and approved applications for humans are clear and long-established. The U.S. Food and Drug Administration (FDA) has authorized its use for several parasitic diseases, which are typically treated with specific tablet or topical formulations.

Oral and Topical Formulations

  • Intestinal strongyloidiasis: This is an infection caused by the parasitic worm Strongyloides stercoralis, often acquired through contact with contaminated soil. Oral ivermectin is an FDA-approved treatment.
  • Onchocerciasis (river blindness): Caused by the parasitic worm Onchocerca volvulus and spread by blackflies, this infection can lead to skin rashes and vision loss. A single dose of oral ivermectin can significantly reduce the number of microfilariae in the skin.
  • Head lice: Some topical formulations of ivermectin are FDA-approved to treat head lice.
  • Rosacea: Topical ivermectin cream is approved by the FDA for treating the inflammatory skin condition rosacea, which is associated with skin mites.

Ivermectin and COVID-19: A Case Study in Misinformation

During the COVID-19 pandemic, ivermectin gained significant and unfounded attention as a potential treatment or preventative measure. This led to a wave of misinformation that had serious public health consequences. The claims were often based on preliminary, low-quality, or fraudulent studies that were not backed by credible scientific evidence or rigorous clinical trials.

Multiple large-scale studies, such as the ACTIV-6 trial, definitively demonstrated that ivermectin provides no clinical benefit for patients with mild to moderate COVID-19. In response, major health organizations, including the FDA and the World Health Organization (WHO), have repeatedly advised against using ivermectin for COVID-19.

The misuse of ivermectin during this period was compounded by people taking animal-specific formulations, which are highly concentrated and contain inactive ingredients not tested for human safety. This led to numerous reports of overdoses and hospitalizations, prompting the FDA to issue strong warnings against using veterinary products on humans.

Important Differences: Human vs. Veterinary Formulations

It is critical to distinguish between ivermectin products intended for humans and those for animals. The two types are fundamentally different in their concentration and formulation, and using the wrong product is extremely dangerous. Veterinary ivermectin, which is used for livestock like horses and cattle, comes in various forms such as pastes, injectables, and pour-ons. The doses are often many times higher than a safe human dose, as they are calibrated for animals weighing thousands of pounds. In contrast, human-grade ivermectin is carefully formulated in specific, FDA-approved doses for tablets or topical use.

The Future of Ivermectin in Pharmaceutical Research

Despite the controversy surrounding its use for COVID-19, ivermectin is a subject of ongoing research for other potential applications. Scientists are exploring its effects in areas beyond its traditional antiparasitic role. These investigations include:

  • Anti-inflammatory effects: Research has shown ivermectin can suppress inflammatory responses, potentially offering benefits for conditions beyond rosacea.
  • Antiviral activity: While not effective for COVID-19, in vitro studies suggest ivermectin may have antiviral effects against other viruses by inhibiting viral protein transportation. These effects have not yet been demonstrated in clinical settings.
  • Anticancer properties: Preliminary research explores ivermectin's potential role in cancer therapy, with studies showing it can inhibit the growth of certain cancer cells in laboratory settings. This is still in the early stages and requires extensive clinical investigation.

These areas of study demonstrate that ivermectin's potential remains a topic of scientific interest, but it underscores the importance of proper, evidence-based research and avoiding unproven, off-label use.

Comparison of Approved Human and Veterinary Ivermectin

Feature Human-Grade Ivermectin Veterinary-Grade Ivermectin
FDA Approval Yes, for specific parasitic and skin conditions Yes, for treating parasites in designated animals
Formulations Tablets, topical creams, and lotions Oral pastes, injectables, and pour-ons
Dosage Precisely measured for human body weight Calculated for large animal species, like horses and cattle
Intended Use Specific FDA-approved human conditions Treating or preventing parasites in animals
Safety for Humans Generally safe when used as prescribed by a doctor Dangerous and potentially toxic due to high concentration and inactive ingredients
Availability Prescription or some OTC topical forms (in some places) Available at farm supply stores, online animal supply outlets

Conclusion

In conclusion, ivermectin is a pharmaceutical with a well-documented and recognized history. Its effectiveness in treating specific human parasitic infections and skin conditions is supported by decades of evidence and FDA approval. However, the controversy surrounding its use for COVID-19 and the dangers of self-medicating with animal formulations highlight a crucial distinction between approved, evidence-based pharmaceutical use and harmful misinformation. While ongoing research into its other potential therapeutic effects is promising, it remains vital for patients to follow the guidance of legitimate health authorities and consult a doctor for appropriate treatment.

For more information on drug approvals and safety, consult reliable sources like the FDA. https://www.fda.gov/

Frequently Asked Questions

Yes, ivermectin is a medication approved for humans. The FDA has approved specific formulations of ivermectin for treating human parasitic infections like intestinal strongyloidiasis and onchocerciasis (river blindness), as well as topical applications for rosacea and head lice.

No, human-grade and veterinary-grade ivermectin are not the same. Veterinary products are formulated for large animals, with significantly higher concentrations and different inactive ingredients, making them unsafe and potentially toxic for humans.

No. The FDA has not authorized or approved ivermectin for the treatment or prevention of COVID-19. Large-scale clinical trials have consistently shown no significant benefit for patients with COVID-19.

The primary pharmaceutical function of ivermectin is as an antiparasitic agent. It works by interfering with the nerve and muscle functions of parasites, causing their paralysis and death.

Common side effects can include dizziness, nausea, vomiting, diarrhea, and fatigue. Taking large doses, especially veterinary formulations, can lead to serious adverse effects like seizures, coma, and low blood pressure.

Ivermectin is a semi-synthetic derivative of avermectin, a compound isolated from the bacterium Streptomyces avermitilis. This bacterium was originally discovered in a soil sample from Japan in the 1970s.

Some states have passed legislation to make ivermectin available over-the-counter (OTC). However, in most cases, oral ivermectin for humans still requires a prescription from a doctor, while some topical versions, such as for head lice, are more commonly available OTC.

The 2015 Nobel Prize in Physiology or Medicine was awarded for the discovery of avermectin and ivermectin, recognizing its tremendous impact in reducing parasitic diseases like river blindness and lymphatic filariasis, particularly in impoverished regions.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.