TGA issues fresh warning over ivermectin as COVID treatment

The Therapeutic Goods Administration (TGA) issued the warning earlier this week and reaffirmed that ivermectin is not approved in Australia to prevent or treat COVID-19 disease, and should not be imported for this indication.
 
‘Treatment of COVID-19 is not a permitted indication for any TGA-approved ivermectin products, which means that the TGA has not assessed the safety and efficacy of these products for this condition,’ the release stated.
 
‘Doctors that prescribe ivermectin off label must consider the potential risks and benefits, and obtain informed consent from patients about the condition and treatment options.
 
‘The TGA strongly discourages self-medication and self-dosing with ivermectin for COVID-19 as it may be dangerous to your health.’
 
The medication, which is typically used for the management and treatment of infections caused by parasites such as mites and worms, has consistently been touted as a potential COVID-19 treatment. However, studies are yet to support its effectiveness as an antiviral against COVID-19, nor determined whether it can improve clinical outcomes.
 
Professor Andrew McLachlan, Head of School and Dean of Pharmacy at the University of Sydney, recently wrote that the majority of ivermectin studies conducted to date show there’s not enough evidence to support its use in treating or preventing COVID-19, either alone or with antibiotics or supplements.
 
‘The initial lab studies into ivermectin’s effect on the coronavirus involved very high concentrations of the drug. These were many times higher than can be achieved in the body at doses recommended to treat parasites,’ he said.
 
‘The most robust summary of the evidence for ivermectin in COVID-19 … concluded ivermectin did not reduce death from any cause, the length of stay in hospital or people’s ability to clear the virus.’
 
Professor McLachlan did say that ivermectin remains a ‘medicine of interest for treating and preventing COVID-19’, but noted that groups including Australia’s National COVID-19 Clinical Evidence Taskforce and the World Health Organization have said it should only be used in clinical trials.
 
The TGA also cited a Cochrane Review that found no evidence to support the use of ivermectin for treating or preventing COVID-19 infection.
 
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