Although Ivermectin is not banned in Australia, it has limited prescription use, including for the treatment of roundworm infections.
The TGA said it had detected increased importation and prescribing of Ivermectin for the treatment of coronavirus.
“(It) is not approved in Australia (or in other OECD countries) to prevent or treat Covid-19 disease and should not be imported for this indication,” the TGA warned on Monday.
“The TGA strongly discourages self-medication and self-dosing with Ivermectin for Covid-19, as it may be dangerous to your health.
“There is insufficient evidence to validate the use of Ivermectin in patients with Covid-19.”
The TGA says there has been an increase in importations of the drug. Picture: Luis Robayo/AFPSource:AFP
Doctors are also warned that if they prescribe Ivermectin off label they must consider the risks and obtain informed consent from patients.
“More evidence-based research is required to determine if Ivermectin could be used as an antiviral medicine to fight against Covid-19 disease,” the TGA said.
“There is a need for larger and consistent randomised controlled clinical trials.”
In July, Cochrane Reviews found no evidence to support the use of Ivermectin for treating or preventing Covid-19 and noted the evidence base was limited.
The TGA also warned about the dangers of buying medication from unverified websites.
“Fake products, known as counterfeits, imitate genuine products but may contain undeclared and hazardous active ingredients,” the TGA said.
“Risky products, especially those sold by online sellers that do not request a doctor’s prescription, can put you at serious risk of unpredictable or severe adverse reactions.
“A lack of manufacturing and testing standards may also result in contaminated products.”