Ivermectin in COVID-19: The Case for a Moratorium on Prescriptions.
Ther Innov Regul Sci
; 56(3): 382-385, 2022 05.
Article
in English
| MEDLINE | ID: covidwho-1682774
ABSTRACT
In treatment or prevention of COVID-19, ivermectin is not approved by the United States (US) Food and Drug Administration (FDA). Nonetheless, in the US, prescriptions of ivermectin by healthcare providers have increased > tenfold from 3589 per week pre-COVID-19 to 39,102. Ivermectin is FDA approved for animals to treat parasites and for humans to treat intestinal strongyloidiasis and onchocerciasis orally, and ectoparasites and skin conditions topically. It is not a benign drug, with reported side effects including cutaneous, gastrointestinal, and cardiovascular symptoms. 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. At present, data from peer-reviewed published randomized trials of sufficient size, dose, and duration to reliably test the hypothesis of the most plausible small to moderate benefits on clinically relevant endpoints are sparse. In addition to the US FDA, the US National Institutes of Health, World Health Organization, and European Medicines Agency have all advised against ivermectin for treatment or prevention of COVID-19 outside of randomized trials. For ivermectin in treatment or prevention of COVID-19, healthcare providers should reassure all patients that if sufficient evidence were to emerge, then this drug could be considered a therapeutic innovation and regulatory authorities would approve the drug. In the meanwhile, we strongly recommend a moratorium on the prescription of ivermectin for the treatment or prevention of COVID-19 except in randomized trials to provide the most reliable test of the hypothesis.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Ivermectin
/
COVID-19 Drug Treatment
Type of study:
Experimental Studies
/
Observational study
/
Prognostic study
/
Randomized controlled trials
Limits:
Animals
/
Humans
Language:
English
Journal:
Ther Innov Regul Sci
Year:
2022
Document Type:
Article
Affiliation country:
S43441-022-00378-0
Similar
MEDLINE
...
LILACS
LIS