Australian regulatory agency TGA reverses restrictions on Ivermectin - now not just certain specialists but general practitioners can prescribe Ivermectin "off-label" (May 3, 2023) - TGA also overreaches (as many others are wont to do) and suggests IVM doesn't work for prophylaxis/anosmia reversal

submitted by stereomatch from self.Ivermectin2

Press Release:

 

https://www.tga.gov.au/news/media-releases/removal-prescribing-restrictions-ivermectin

Removal of prescribing restrictions on ivermectin

3 May 2023

 

Archive:

https://archive.ph/HPrVd

 

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.

 

Links: https://www.tga.gov.au/resources/publication/scheduling-decisions-final/notice-final-decision-amend-or-not-amend-current-poisons-standard-acms-40-accs-34-joint-acms-accs-32

or

https://archive.ph/dGNOI

PDF:

https://www.tga.gov.au/sites/default/files/2023-05/notice-of-final-decision-to-amend-or-not-amend-the-current-poisons-standard-acms-40-accs-34-joint-acms-accs-32.pdf

 

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.

 

Links:

https://www.tga.gov.au/news/media-releases/new-restrictions-prescribing-ivermectin-covid-19

or

https://archive.ph/Xwbvl

 

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.

Contact for members of the media:

Email: news@health.gov.au

Phone: 02 6289 7400

 

 

Twitter thread:

 

https://twitter.com/real_GGoswami/status/1653631593955876865

Gautam Goswami

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.

 

https://twitter.com/stereomatch2/status/1653927849706016768

StereoMatch

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

https://www.tga.gov.au/sites/default/files/2023-05/notice-of-final-decision-to-amend-or-not-amend-the-current-poisons-standard-acms-40-accs-34-joint-acms-accs-32.pdf

 

https://twitter.com/stereomatch2/status/1653929912133357568

StereoMatch

pg 17:

.. 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.

Image:

https://imgur.com/a/SeypqbK

 

https://twitter.com/stereomatch2/status/1653930279541800961

StereoMatch

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)

 

https://twitter.com/stereomatch2/status/1653930789229465602

StereoMatch

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..

 

https://twitter.com/stereomatch2/status/1653931037611950081

StereoMatch

How did they extend that to also suggest IVM is not effective for:

  • prophylaxis

  • anosmia reversal

Which studies is their conclusion based on?

Overreach?

 

https://twitter.com/stereomatch2/status/1653932151455510528

StereoMatch

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)

 

https://twitter.com/stereomatch2/status/1653932657682808832

StereoMatch

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?

 

https://twitter.com/stereomatch2/status/1653937734124437504

StereoMatch

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?

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[–]Amirr010 2 insightful - 1 fun2 insightful - 0 fun3 insightful - 1 fun -  (0 children)

In a recent decision, the Australian regulatory agency TGA reversed its restrictions on Ivermectin, allowing its use under revised guidelines. This move has sparked significant debate within the medical community, especially when comparing treatment options for weight management. For example, comparing ozempic vs phentermine shows differing approaches to managing conditions like obesity. While Ozempic is a newer option for diabetes management with weight loss benefits, Phentermine remains a long-established appetite suppressant. The TGA's decision could influence treatment protocols and options available to patients in Australia.

[–][deleted] 1 insightful - 1 fun1 insightful - 0 fun2 insightful - 1 fun -  (0 children)

It’s still not over the counter in most of the US.

[–]stereomatch[S] 1 insightful - 1 fun1 insightful - 0 fun2 insightful - 1 fun -  (0 children)

The effect for prophylaxis and anosmia reversal is very visible.

For anosmia reversal see the evidence here:

https://saidit.net/s/Ivermectin2/wiki/index#wiki_ivermectin_and_post-covid19_anosmia.2Ffatigue_reversal