The TGA has issued a statement warning that Ivermectin is not approved for the treatment of COVID-19, following increased importation and prescribing
The Therapeutic Goods Administration says that it has detected increased importation and prescribing of Ivermectin for the treatment of COVID-19.
“Ivermectin is a prescription medicine that 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,” it warns.
“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.”
It points out Ivermectin’s indications in Australia: Ivermectin is indicated in the management and treatment of infections caused by parasites, such as mites and worms. In Australia, Ivermectin has been approved for the treatment of roundworm infections, scabies and inflammatory rosacea.
“Antiviral efficacy against COVID-19 and improvement to clinical outcomes from Ivermectin have not been proven,” the TGA warns.
It points out that it has not assessed the safety and efficacy of Ivermectin products for COVID-19.
“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,” says the TGA.
“More evidence-based research is required to determine if Ivermectin could be used as an antiviral medicine to fight against COVID-19 disease. There is a need for larger and consistent randomised controlled clinical trials.”
The TGA notes that a July 2021 Cochrane Review found no evidence to support the use of Ivermectin for treating or preventing COVID-19 infection, and noted that the evidence base is limited.
It also warned the general public against buying medicines online from unverified websites.
“Fake products, known as counterfeits, imitate genuine products but may contain undeclared and hazardous active ingredients.
“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.
“Caution is also advised before importing unapproved medicines into Australia for personal use. The TGA does not evaluate unapproved therapeutic goods for quality, safety and efficacy when imported via the Personal Importation Scheme.”