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 Epoch Times has reached out to the TGA for further information.
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 its announcement 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 added that people who think they are protected from COVID-19 by taking ivermectin “may choose not to get tested or to seek medical care if they experience symptoms,” and claimed that doing so “has the potential to spread the risk of COVID-19 infection throughout the community.”
The TGA said that a second 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.
“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 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,” its 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.