Wednesday, 19 June, 2024
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Australian regulator bans off-label Ivermectin use as prescriptions climb

Ivermectin has been banned from off-label use in Australia, except by certain specialists, after the number of people using it as aN unproven treatment for COVID-19 increased up to fourfold.

Certain specialists including infectious disease physicians, dermatologists, gastroenterologists and hepatologists will continue to be permitted to prescribe Ivermectin for other unapproved indications if they believe it is appropriate for a particular patient.

The Therapeutic Goods Administration (TGA) has banned the anti-parasitic drug from being prescribed for illnesses not described in its licence because it is concerned people are taking the medication instead of seeking approved treatment or having the COVID vaccines.

The TGA said that there were concerns over possible shortages for the drugʼs intended uses, such as TGA-approved conditions including scabies and certain parasitic infections. It had acted on advice from the Advisory Committee on Medicines Scheduling to ban the drug for most off-label use over concerns that people would overdose, saying that high doses are linked to effects as serious as seizures and coma.

The TGA said in a statement:

These changes have been introduced because of concerns with the prescribing of oral Ivermectin for the claimed prevention or treatment of COVID-19. Ivermectin is not approved for use in COVID-19 in Australia or in other developed countries, and its use by the general public for COVID-19 is currently strongly discouraged by the National COVID Clinical Evidence Taskforce, the World Health Organisation and the US Food and Drug Administration.

Firstly, there are a number of significant public health risks associated with taking Ivermectin in an attempt to prevent COVID-19 infection rather than getting vaccinated. Individuals who believe that they are protected from infection by taking Ivermectin may choose not to get tested or to seek medical care if they experience symptoms. Doing so has the potential to spread the risk of COVID-19 infection throughout the community.

Secondly, the doses of Ivermectin that are being advocated for use in unreliable social media posts and other sources for COVID-19 are significantly higher than those approved and found safe for scabies or parasite treatment. These higher doses can be associated with serious adverse effects, including severe nausea, vomiting, dizziness, neurological effects such as dizziness, seizures and coma.

Finally, there has been a 3-4-fold increased dispensing of Ivermectin prescriptions in recent months, leading to national and local shortages for those who need the medicine for scabies and parasite infections. It is believed that this is due to recent prescribing and dispensing for unapproved uses, such as COVID-19.  Such shortages can disproportionately impact vulnerable people, including those in Aboriginal and Torres Strait Islander communities.

There is only one TGA approved oral ivermectin product, Stromectol ivermectin 3mg tablet blister pack which is indicated for the treatment of river blindness (onchocerciasis), threadworm of the intestines (intestinal strongyloidiasis) and scabies.

Last week, a Sydney hospital reported that a patient was admitted after overdosing on Ivermectin and a mixture of other claimed COVID “cures” found online.


The Independent article – Ivermectin: Australian regulator bans drug as off-label Covid treatment after sharp rise in prescriptions


See more from MedicalBrief archives:


Ivermectin is not a ‘miracle drug’ against COVID. Vaccines are


Ivermectin: Studies come thick and fast; Regulators remain unmoved


Merck warns on Ivermectin for COVID: No evidence of efficacy and safety



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