Australia’s Therapeutic Goods Administration (TGA) placed new restrictions on the prescribing of oral ivermectin, according to an announcement last Friday.
General practitioners are now only able to prescribe ivermectin for TGA-approved conditions (indications) – scabies and certain parasitic infections. Certain specialists including infectious disease physicians, dermatologists, gastroenterologists and hepatologists (liver disease specialists) will be permitted to prescribe ivermectin for other unapproved indications if they believe it is appropriate for a particular patient.
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 Organization 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.
All medical practitioners can continue to prescribe oral ivermectin for the approved indications. However, prescribing of oral ivermectin for indications that are not approved is now limited to certain specialists.