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 TGA, an agency under Australia’s Department of Health, announced that the changes were introduced “because of concerns with the prescribing of oral ivermectin for the claimed prevention or treatment of COVID-19.”
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.
The TGA told The Epoch Times in an emailed statement, “The implementation of the Poisons Standard, including the recent restrictions to General Practitioner prescribing of ivermectin, is given legal effect through relevant state and territory drugs, poisons and controlled substances legislation. This includes penalties for breaching the conditions in the Poisons Standard that are adopted into states and territories legislation.”
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.
Ivermectin is not TGA-approved for use to treat COVID-19 in Australia. The TGA said that its use for COVID-19 in the general public is “currently strongly discouraged” by three entities—the National COVID Clinical Evidence Taskforce (pdf), the World Health Organization, and the U.S. Food and Drug Administration.
TGA Lays Out Concerns
The 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 agency cited a recent review of ivermectin trials by the Cochrane Collaboration, in which the authors said they were “uncertain about the efficacy and safety of ivermectin used to treat or prevent 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 Cochrane review has been criticized by Robert Clancy, a leading Australian clinical immunologist, who penned a commentary in Quadrant saying the review was “out of line with a series of supportive meta-analyses by non-conflicted competent epidemiologists.”
“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.”
“It is believed that this is due to recent prescribing and dispensing for unapproved uses, such as COVID-19,” the TGA’s statement reads. “Such shortages can disproportionately impact vulnerable people, including those in Aboriginal and Torres Strait Islander communities.”
Immediate Backlash by MPs
Two Australian politicians immediately issued announcements late Sept. 10 criticizing the TGA restrictions.
Federal MP George Christensen, a Liberal Party member from the state of Queensland, posted on Telegram a photo of his medications, writing, “My ivermectin treatment pack. Prescribed by a GP. Now the TGA has banned GPs from prescribing the drug off-label. It’s a decision they will regret.”
Christensen also shared a lengthy list of studies, writing, “here’s some REAL INFO on IVERMECTIN.”
Federal MP Craig Kelly, a former Liberal Party member and now leader of the United Australia Party, in a statement posted on Telegram called the TGA move “OUTRAGEOUS” and accused the agency of having “interfered with the sanctity of the Doctor patient relationship in Australia, by ignoring the evidence of over 50 published studies and also ignoring expert medical advice from doctors that have treated thousands of patients successfully with Ivermectin—by prohibiting doctors from prescribing this medicine to sick Australians.”
“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.
Ivermectin 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.
Doctors and health care professionals have considered ivermectin as a repurposed medicine in tackling COVID-19, especially when used in early treatment. Many have praised ivermectin for having successfully helped thousands of their patients survive the initial waves of COVID-19.
As of Sept. 9, there are at least 63 studies, of which 45 are peer-reviewed, on the treatment of COVID-19 with ivermectin.
Two groups, the Front Line COVID-19 Critical Care Alliance and the British Ivermectin Recommendation Development Group, have been campaigning for the off-label use of the drug to combat the disease amid the pandemic.
Monash University, based in the Australian state of Victoria, announced in April 2020 that a study it led showed that “a single dose of the drug, Ivermectin, could stop the SARS-CoV-2 virus growing in cell culture.”
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.
Editor’s note: This article has been updated with added statements from the TGA.