Removal of prescribing restrictions on ivermectin
3 May 2023
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 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.
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.
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TGA #Australia has announced today (3 May 2023), that 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.
Decision was made roughly on:
that everyone's vaccinated now (so less impact on vaccine hesitancy)
everyone now knows IVM "doesn't work" for prophylaxis and covid19
high dose studies suggest side effects are few and well understood
.. the 2021 decision are now appropriately mitigated through the high vaccination rate and immunity conferred by both prior infection and vaccination (hybrid immunity) in Australia, .. doses, frequency and duration of ivermectin use, demonstrate a low-risk of toxicity.
I have confidence that the volume of published studies demonstrating the lack of efficacy of ivermectin for the prophylaxis and treatment of COVID-19 enables all medical practitioners to exercise sound judgement when considering the specific use of ivermectin for COVID-19.
(also pg. 17)
Only problem with this TGA assertion is that the bulk of the anti-IVM studies are on "mortality benefit"
Even if we allow Lopez-Medina, TOGETHER, ACTIV-6 (which all use similar methodology - empty stomach, late use and gaffes) to trump previous "mortality benefit" trials..
How did they extend that to also suggest IVM is not effective for:
Which studies is their conclusion based on?
The anti-IVM studies don't have much to say about prophylaxis/anosmia
(Lopez-Medina even avoided reporting anosmia status at end!)
The bulk of the prophylaxis/anosmia studies remain unchallenged
In the real world the effect is also easier to observe (usually single drug given)
So why do anti-IVM activists repeately trip over themselves to say "everyone knows IVM doesn't work for covid19" ?
When the most they could claim to say is "it doesn't work for mortality benefit" (those are the anti-IVM studies they have on hand)
Why say more?
Why is there such wishy washy imprecise language and thinking from regulatory bodies?
How do they extrapolate "mortality benefit" to prophylaxis and anosmia non-benefit?
To then say "IVM has no benefit for covid19" ?
What universe of logic allows this jump?