Australia's medicine and therapeutics regulator, the Therapeutic Goods Administration (TGA), has introduced new restrictions on the prescribing of ivermectin for COVID-19 and other off-label use.
The new restrictions mean that general practitioners may only prescribe the drug for TGA-approved conditions and not for other non-approved purposes—also referred to as "off-label" use. No penalties were specified in the TGA announcement in the event of a GP skirting the rules.
Only certain specialists can continue to prescribe oral ivermectin for off-label use. They include infectious disease physicians, dermatologists, gastroenterologists, and hepatologists, the TGA announced.
Stromectol ivermectin 3mg is the only oral ivermectin product that is TGA-approved. The indications approved are river blindness, threadworm of the intestines, and scabies.
TGA Lays Out ConcernsThe TGA in an email to The Epoch Times said that it "strongly recommends against the routine use of ivermectin in the treatment of COVID-19 because of the lack of robust data supporting its effectiveness, as well as the risk of significant adverse effects including nausea, vomiting, dizziness, seizures and coma at the potential doses claimed to be of use in COVID-19."
The TGA told The Epoch Times, "Evidence from well-conducted large, prospective and randomised controlled studies is needed before the efficacy and safety of ivermectin for the treatment of COVID-19 can be understood. Without this, as is the case for any unproven treatment, the risks of taking ivermectin outweigh any potential benefit to COVID-19 patients."
"The information source used to formulate policy in Australia is both out of kilter with conclusions from over 60 controlled clinical trials and the positive experience recorded when IVM was used in national and regional programmes," Clancy wrote, referring to the Cochrane review. "Cochrane is an incomplete and unreliable basis for decision making on COVID-19 management in an Australian context. The views of international experts are trumped by unknown local bureaucrats."
In the TGA's announcement on Sept. 10, it asserted 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."
The agency suggested, providing no evidence, that there may be people who think they are protected from COVID-19 by taking ivermectin, who "may choose not to get tested or to seek medical care if they experience symptoms." The TGA commented that such an action "has the potential to spread the risk of COVID-19 infection throughout the community."
The TGA said that another concern involves "unreliable social media posts and other sources" that have reportedly advocated for the use of ivermectin in "significantly higher" doses compared to what is approved and found safe for the treatment of scabies or parasites. The agency provided no evidence for such social media posts.
"These higher doses can be associated with serious adverse effects, including severe nausea, vomiting, dizziness, neurological effects such as dizziness, seizures, and coma."
The regulator also said that there has been a three- to four-fold increase in the dispensing of ivermectin prescriptions in recent months, which it claimed has resulted in "national and local shortages for those who need the medicine for scabies and parasite infections."
Immediate Backlash by MPsTwo Australian politicians immediately issued announcements late Sept. 10 criticizing the TGA restrictions.
"The UNITED AUSTRALIA PARTY tonight calls for [an] urgent Royal Commission in this TGA over this decision," he wrote, saying that the decision "could be investigated for possible corruption."
"It’s a sad day for the nation, as the expert medical evidence from overseas indicates that this outrageous decision by the TGA will result in the death of Australians," Kelly added.
On IvermectinIvermectin is a generic medicine that can be produced cheaply in many places around the world and has been widely used in humans against some parasitic worms, and to combat scabies, lice, as well as rosacea. It is also used as an anti-parisite drug in livestock, including horses and cows.
William Campbell and Satoshi Omura in 2015 won the Nobel Prize in Physiology or Medicine for the discovery and applications of ivermectin. The World Health Organization features ivermectin on its List of Essential Medicines. It is also an FDA-approved antiparasitic agent.
But it cautioned that ivermectin "cannot be used in humans for COVID-19 until further testing and clinical trials have been completed to confirm the effectiveness of the drug at levels safe for human dosing."
"The potential use of Ivermectin to combat COVID-19 remains unproven, and depends on funding to progress the work into the next stages," the university said at the time.