Prescribing oral Ivermectin for “off-label use” will no longer be limited to specialists like dermatologist, gastroenterologists and infections disease experts, says Australia’s Therapeutic Goods Administration (TGA), which, however, still does not endorse the medication for the treatment or prevention of Covid-19.
MedicalBrief reports the organisation said in a notice that it had 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”.
The decision takes into consideration the evidence and awareness of medical practitioners about the risks and benefits of Ivermectin, and the low potential for any shortages of the drug for its approved uses.
The TGA said that additionally, 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”.
It added that large number of clinical studies had demonstrated Ivermectin “does not improve outcomes in patients with Covid-19”.
“The National Covid Evidence Taskforce (NCET) and many similar bodies around the world, including the World Health Organisation, strongly advise against the use of Ivermectin for the prevention or treatment of Covid-19.”
Ivermectin for oral use is a prescription only (Schedule four) medicine in the Poisons Standard, approved by the TGA only for the treatment of river blindness (onchocerciasis), threadworm of the intestines (intestinal strongyloidiasis), and scabies.
The restriction was introduced in September 2021 because of concerns about people using the drug without health advice in attempts to treat Covid-19; widespread use of the medication instead of approved vaccines and treatments for Covid-19; and potential shortages of it for approved uses.
notice-of-final-decision-to-amend-or-not-amend-the-current-poisons-standard-acms-40-accs-34-joint-acms-accs-32
Australian Department of Health & Aged Care notice (Open access)
See more from MedicalBrief archives:
Australian regulator bans off-label Ivermectin use as prescriptions climb
Unproven Ivermectin resurfaces as treatment for long COVID patients
Increased human use of veterinary Ivermectin reflected in Oregon Poison Centre calls
Ivermectin: Further claims of ‘serious errors or potential fraud’ in studies