The European Medicines Agency (EMA) does not recommend the use of ivermectin in the prevention or treatment of Covid-19 outside of clinical trials.
The ESA assessed the recent evidence for the use of ivermectin in the prevention and treatment of Covid-19 and concluded that the available data do not support its use in Covid-19 outside of well-designed clinical trials.
In the European Union, ivermectin tablets are approved for the treatment of several parasitic worm infestations, while dermal ivermectin preparations are approved for the treatment of skin diseases such as rosacea. Ivermectin has also been authorized for veterinary use in internal and external parasites in many species.
Ivermectin-containing medicines have not been authorized for use in the European Union for Covid-19, and no application has been received from EZA for such use.
Following recent media articles and publications on the use of ivermectin, the ESA evaluated the latest published evidence from laboratory studies, drug use observations, clinical trials and meta-analyzes. Laboratory studies have shown that ivermectin may inhibit the replication of SARS-CoV-2 (the virus that causes Covid-19), but requires much higher concentrations of ivermectin than can be achieved with currently recorded doses. Clinical trials have shown mixed results, with some studies showing no benefit but others reporting a potential benefit. Most of the studies evaluated by the ESA were small and had a number of shortcomings, including differences in the dosage of the medicine and the concomitant use of other medicines. Therefore, the ESA concluded that the currently available evidence was insufficient to support the use of ivermectin in Covid-19 outside of clinical trials.
Although ivermectin is generally well tolerated at the doses recorded for other indications, when used at much higher doses than may be required to achieve antivirally effective ivermectin concentrations in the lungs, its side effects may be exacerbated. Therefore, toxicity of ivermectin cannot be ruled out at doses higher than those recorded.
Therefore, the ESA concluded that the use of ivermectin for the prevention and treatment of Covid-19 is currently not recommended outside of controlled clinical trials. Further well-designed, randomized studies are needed to draw conclusions about the effectiveness and safety of this medicine for the prevention and treatment of Covid-19.
This ESA public health statement is supported by the ESA Covid-19 Pandemic Working Group (COVID-ETF) in the context of the ongoing discussions on the use of ivermectin for the prevention and treatment of Covid-19.