The Therapeutic Goods Administration has ended a ban on off-label prescriptions of anti-parasitic drug ivermectin, nearly two years after floods of people attempted to procure the drug in the mistaken belief it would treat Covid-19.
The TGA announced on Wednesday it would remove the ban for off-label prescriptions of the drug from 1 June. Off-label prescriptions had been limited to specialists such as dermatologists, gastroenterologists and infectious disease specialists since September 2021.
The decision was made due to what the TGA said was “sufficient evidence that the safety risks to individuals and public health is low” in the “current health climate”.
The high rates of vaccination against Covid-19 in Australia and high hybrid immunity meant that use of the drug by people was “unlikely to now compromise public health” including the risk of potential shortages of the drug for its stated use for treating river blindness, threadworm of the intestines, and scabies.
But the regulator stressed the lifting of the ban did not amount to an endorsement of off-label prescribing of ivermectin to treat Covid-19, citing studies showing it was not an effective treatment.
“A large number of clinical studies have 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 Organization, strongly advises against the use of ivermectin for the prevention or treatment of Covid-19.”
At the time of the ban, off-label prescriptions of ivermectin for Covid-19 were being discussed quietly in Facebook and Telegram communities, with people sharing the names of sympathetic doctors who were willing to prescribe it. The TGA said at the time it was concerned that people could be taking unsafe doses of the drug if following advice from social media.
There had been a three-to-fourfold increase in ivermectin prescriptions in the months in the lead up to the ban sparking shortages, and a tenfold increase in people seeking to import the drug. Pharmacists also reported a rise in people presenting for prescriptions and not saying what it was sought for.
Westmead hospital in Sydney also reported at the time a patient was admitted after overdosing on ivermectin and a cocktail of other claimed Covid-19 cures found online.
One of the major political proponents of the treatment – Clive Palmer’s United Australia party - heralded in a tweet the lifting of the ban as a victory, saying Palmer and Craig Kelly “spoke out bravely in [the] face of relentless attacks from governments and government agencies”, and called for a royal commission into the Covid-19 response.
The TGA said the decision to lift the ban took into account advice from the independent advisory committee on medicines scheduling, and two rounds of public consultation.
