Ivermectin should only be used as COVID-19 treatment in large clinical trials
Researchers recommend a moratorium on prescribing ivermectin to treat or prevent COVID-19, except to provide the necessary evidence in data from large-scale randomized trials, according to a news release from Florida Atlantic University.
Ivermectin is a drug approved by the U.S. Food and Drug Administration (FDA) to treat parasites in animals and in humans with intestinal strongyloidiasis (roundworm) and onchocerciasis (river blindness) orally, as well as ectoparasites and skin conditions topically. Ivermectin is not approved by the FDA to treat or prevent COVID-19.
Nonetheless, prescriptions of ivermectin by U.S. healthcare providers increased more than tenfold from 3,589 per week pre-COVID-19 to 39,102. In addition, the U.S. National Institutes of Health (NIH), World Health Organization (WHO) and European Medicine Agency (EMA) have all advised against using ivermectin to treat or prevent COVID-19.
In a commentary published in the journal Therapeutic Innovation & Regulatory Science, researchers from Florida Atlantic University’s Schmidt College of Medicine and collaborators, urge all healthcare providers to always prioritize compassion with reliable evidence on efficacy and safety. As such, they recommend a moratorium on prescribing ivermectin to treat or prevent COVID-19, except to provide the necessary evidence in data from large-scale randomized trials.
“The evidence to support ivermectin to treat or prevent COVID-19 includes some basic research and inconsistent clinical observations that contribute to the formulation of a hypothesis of efficacy in COVID-19,” said Scott M. Alter, MD, MBA, Associate Research Professor and an Associate Professor of Emergency Medicine, FAU Schmidt College of Medicine. “Currently, data from peer-reviewed published randomized trials of sufficient size, dose and duration are sparse to reliably test the hypothesis of small-to-moderate benefits on clinically relevant endpoints.”
The researchers caution ivermectin is not a benign drug and has reported side effects that include cutaneous, gastrointestinal and cardiovascular symptoms. Specifically, skin rash, nausea, vomiting, diarrhea, stomach pain, hypotension, dizziness, and seizures have been reported.
The authors note that last year, officials at Merck, the manufacturer of ivermectin, stated that they also believe that the available data do not support the safety and efficacy of the drug beyond the doses and populations indicated in the regulatory agency-approved prescribing information. In addition, last summer, a meta-analysis of 14 trials, concluded that the currently available evidence does not support the prescription of ivermectin for treatment or prevention of COVID-19.
As a cautionary note, the researchers compare similarities in prescriptions of ivermectin to hydroxychloroquine, whose emergency use authorization was withdrawn by the FDA following the results of large-scale trials that demonstrated a lack of efficacy and possible harm for the treatment and prevention of COVID-19.
