Source: www.tga.gov.au
From 1 June 2023, prescribing of oral ivermectin for ‘off-label’ uses will no longer be limited to specialists such as dermatologists, gastroenterologists and infectious diseases specialists.
In its final decision published today, the Therapeutic Goods Administration (TGA) has removed the restriction through its scheduling in the Poisons Standard 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.
This considers the evidence and awareness of medical practitioners about the risks and benefits of ivermectin, and the low potential for any shortages of ivermectin for its approved uses. Also, given the high rates of vaccination and hybrid immunity against COVID-19 in Australia, use of ivermectin by some individuals is unlikely to now compromise public health.
However, the TGA does not endorse off-label prescribing of ivermectin for the treatment or prevention of COVID-19.
A large number of clinical studies have demonstrated ivermectin does not improve outcomes in patients with COVID-19. The National Clinical Evidence Taskforce (NCET) and many similar bodies around the world, including the World Health Organization, strongly advises against the use of ivermectin for the prevention or treatment of COVID-19.
Ivermectin for oral use is a Prescription Only (Schedule 4) medicine in the Poisons Standard. It is only approved by the TGA for the treatment of river blindness (onchocerciasis), threadworm of the intestines (intestinal strongyloidiasis), and scabies.
The restriction on ivermectin was introduced in September 2021 because of concerns about the safety of consumers using ivermectin without health advice to treat COVID-19, widespread use of ivermectin instead of approved vaccines and treatments for COVID-19, and potential shortages of the medicine for approved uses.
The final decision follows an application to remove the restrictions and has been made according to the process required under the Therapeutic Goods Act 1989. It takes into account advice from the independent Advisory Committee on Medicines Scheduling (ACMS) and two rounds of public consultation.