Other safety alerts
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| Australia: Removal of prescribing restrictions on ivermectin |
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The Therapeutic Goods Administration (TGA) announces that prescribing of oral ivermectin for ‘off-label’ uses will no longer be limited to specialists such as dermatologists, gastroenterologists and infectious diseases specialists from 1 Jun 2023.
In its final decision published on 3 May 2023, the 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 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 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 Sep 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.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/media-releases/removal-prescribing-restrictions-ivermectin
In Hong Kong, there is one registered pharmaceutical product for human use containing ivermectin, namely Soolantra Cream 10mg/g (HK-64980). This product is registered by Galderma Hong Kong Limited. It is a prescription-only medicine which is indicated for the topical treatment of inflammatory lesions of rosacea in adult patients. Related news was previously issued by TGA, and was posted on the Drug Office website on 11 Sep 2021. The Department of Health will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Wednesday, May 3, 2023
Issued at HKT 15:00
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