The TGA has imposed new restrictions on the prescribing of oral ivermectin, concerned about its off-label use in COVID-19
The Therapeutic Goods Administration made the move following advice from the Advisory Committee for Medicines Scheduling.
“General practitioners are now only able to prescribe ivermectin for TGA-approved conditions… scabies and certain parasitic infections,” the TGA said.
“Certain specialists including infectious disease physicians, dermatologists, gastroenterologists and hepatologists… 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,” said the TGA.
“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.”
It said that 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,” the TGA warned.
“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 three-four-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.”
Earlier this month an overdose of ivermectin was reported in a COVID-positive patient who went to Westmead Hospital.
The person had taken ivermectin as well as other products they hoped would treat the novel coronavirus, all sourced online. The person recovered from the overdose.
At the time, Pharmaceutical Society of Australia national president A/Prof Chris Freeman told the AJP that pharmacists were reporting an increase in the number of people presenting with ivermectin scripts, but unwilling to discuss the therapeutic purpose.
“Some members have explained that when they’ve gone to have a conversation around what the indication for Ivermectin was, the patient has become very defensive, and refused to continue the conversation with the pharmacist,” Dr Freeman said.
“When the pharmacist understands that the patient intends to use Ivermectin as a prophylactic against COVID-19, or to have on hand should they get COVID-19, and the pharmacist has tried to explain that that’s potentially inappropriate, it’s caused some confrontation with the pharmacist and the patient.”
The TGA reminded health professionals that 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,” it said.
“However, prescribing of oral ivermectin for indications that are not approved is now limited to certain specialists.”