Dispensing rates have shot up over threefold, causing drug shortages for those with a legitimate need, the TGA warns.
GPs are now only permitted to prescribe oral ivermectin for TGA-approved conditions such as scabies and specific parasites.
The TGA’s announcement, based on advice from the Advisory Committee for Medicines Scheduling, came in response to the burgeoning – and baseless – interest in the drug as a prevention and cure for covid.
In Australia, dispensing rates have shot up at least threefold, leading to shortages for patients needing it for legitimate reasons.
People taking higher doses of the drug, which has been spruiked online and on social media, have suffered severe nausea, vomiting, dizziness, seizures and have even become comatose.
“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,” the regulator warned on Friday.
Not only were people taking the parasite medication off-label at risk of serious adverse events, but they were also less likely to seek medical care or testing for covid symptoms because of their misplaced belief that they were protected.
Stromectol (ivermectin) 3mg is the only oral formulation approved by the TGA, and it is indicated for the treatment of scabies, intestinal strongyloidiasis and river blindness (onchocerciasis).
“Such shortages can disproportionately impact vulnerable people, including those in Aboriginal and Torres Strait Islander communities,” the TGA said.
While GPs can continue to prescribe the drug only for those approved indications, other specialists have more latitude.
“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.”