AUSTRALIA – The Therapeutic Goods Administration (TGA) announced today that doctors will be free to prescribe ivermectin “off-label” starting on 1 June 2023.
In its final decision, the TGA removed restrictions on the drug because there is “sufficient evidence that the safety risks to individuals and public health is low when prescribed by a general practitioner in the current health climate.”
Australia’s drug regulator banned ivermectin for “off-label” use, such as treating COVID-19, in September 2021.
In a 2021 press release, the TGA said that only general practitioners could prescribe the drug for “TGA-approved conditions.” These included the treatment of scabies and other parasitic infections.
The TGA also allowed particular specialists to prescribe ivermectin for “other unapproved indications” if they believed it was appropriate for a particular patient.
However, this discretion afforded to doctors when prescribing this medication did not include treatment for COVID-19.
During the pandemic, the TGA was concerned that people were taking ivermectin to treat COVID-19, instead of seeking “approved treatments” or getting vaccinated.
The Australian media routinely described the anti-parasitic medication as a “livestock de-wormer” when reporting on the drug and its use.
Ivermectin has a range of applications in both humans and animals, with different formulations of the drug being used to treat different conditions in both.
In people, America’s FDA has approved prescription ivermectin tablets to treat two infections caused by parasitic worms. Doctors can also prescribe a formulation of the drug for topical use – especially for those suffering from head lice or skin conditions like rosacea or scabies.
Australia, along with multiple Western countries, restricted access to the drug during the pandemic. The drug is hotly debated as a method to treat and prevent COVID-19.
The National COVID Evidence Taskforce (NCET) strongly advises against the use of ivermectin for the prevention or treatment of COVID-19.
That said, the Spectator Australia‘s Rebecca Weisser wrote in July 2021:
“As for safety, 3.7 billion doses of ivermectin have been used since 1987 and in 30 years, only 20 deaths following its use have been reported to the UN’s Vigi-Access database. Compare that to remdesivir, which has been given emergency use authorisation to treat COVID in Australian hospitals. In 12 months, there have been 551 deaths reported. Indeed, a study published in the prestigious Journal of the American Medical Association this week found remdesivir did not increase survival, just time spent in hospital.”
According to journalist Rebekah Barnett, Melbourne-based Monash University has been a conducting a placebo-controlled, double-blinded clinical trial to test the efficacy of ivermectin for COVID-19 prevention.
The trial’s lead doctor, Kylie Wagstaff, previously carried out preliminary research into the drug with the Doherty Institute.
In April 2020, the researchers reported that ivermectin stopped the “replication of the SARS-CoV-2 virus in cell culture within 48 hours.”
They also suggested that “ivermectin…warrants further investigation for possible benefits in humans.”