Australia's medicines watchdog says more people are importing a controversial and unproven drug in an attempt to combat COVID-19.
The Therapeutic Goods Administration (TGA) has reported increased importation and prescription of Ivermectin.
Ivermectin is an anti-viral medication that has been approved by the TGA for the treatment of roundworm infections, scabies and inflammatory rosacea. However, it has not been approved to treat or prevent COVID-19.
The Feed sent a media request to the Department of Health last week after observing a shortage notice for the drug from 2 August to 23 August 2021 due to an “unexpected increase in consumer demand".
A spokesperson said the Ivermectin shortage for the STROMECTOL 3mg tablet blister pack has since been “resolved”.
On its website, the TGA said it strongly discourages self-medication with Ivermectin as it “may be dangerous to your health.”
“There is insufficient evidence to validate the use of Ivermectin in patients with COVID-19,” the TGA added.
On Friday, Mississippi’s health department issued that over 70 per cent of recent calls to the state’s poison centre came after people took ivermectin bought at livestock supply centres.
This prompted the US Food and Drug Administration to issue an uncharacteristically blunt statement about Ivermectin: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
The FDA has approved Ivermectin in small doses to treat parasitic worms. Larger doses can be dangerous to humans and are often used against parasites in livestock.
Before he was banned from Facebook for “misinformation”, Member for Hughes Craig Kelly shared information about Ivermectin on his social media page almost daily.
On Twitter and Telegram, the Independent MP continues to spruik the drug’s supposed benefits against the virus.
“More cases, more pain & suffering ALL because they WON’T release the IVERMECTIN,” Mr Kelly wrote on Twitter on Sunday.
“OBSESSION with suppressing Ivermectin denying medical choice AND costing lives,” he wrote in another tweet.
Federal member for Hughes Craig Kelly resigned from the Liberal Party to become an Independent MP. Source: AAP
The Department of Health spokesperson said despite some studies published “on unreferenced websites or in lower-tier medical journals, the consensus view of major regulators and in top-tier international medical journals is that the evidence for the clinical efficacy and safety of ivermectin for the treatment of COVID-19 is not strong at this stage.”
The spokesperson added the National COVID-19 Clinical Evidence Taskforce advised against the use of Ivermectin to treat COVID-19 outside clinical trials “without appropriate approval.”
Professor Andrew McLachlan, Dean of Pharmacy at Sydney University, said he was not surprised to see Ivermectin in high demand during the pandemic.
“We have seen this for other medicines that have been claimed to be COVID treatments such as hydroxychloroquine,” he told The Feed.
Hydroxychloroquine is an anti-malaria drug used to treat rheumatoid arthritis and lupus, according to the Australian Medical Association (AMA).
The World Health Organisation has said hydroxychloroquine is ineffective as a treatment for COVID-19 Source: AFP
Professor McLachlan said he was seeing a lot of misinformation about Ivermectin and other supposed COVID treatments and preventatives online.
“[This is] often related to misunderstanding or misinformation – perhaps vested interests or false hope,” he said.
Ivermectin has had “a chequered history when it comes to treating COVID-19”, according to Professor McLachlan.
“The bulk of studies so far show there’s not enough evidence Ivermectin is useful in treating or preventing COVID-19, either alone or with antibiotics or supplements,” he said.
Professor McLachlan said Ivermectin was first identified as a potential COVID-19 treatment based on experiments in isolated cells and animals.
However, he said the initial lab studies into Ivermectin’s effect on COVID-19 involved very high concentrations of the drug that were “many times higher than can be achieved in the [human] body.”
The most recent high-quality, study evidence of Ivermectin trials was published in . The trials found no strong evidence to support the use of Ivermectin for the treatment or prevention of COVID-19 “outside of well‐designed randomised trials.”
In June, researchers at the University of Oxford announced they would be starting another Ivermectin trial, called , investigating treatments for people at more risk of serious COVID-19.
“Ivermectin remains a medicine of interest for treating and preventing COVID-19,” Professor McLachlan said.
“Yet, key questions remain including the best Ivermectin dose, how long Ivermectin should be taken and when it should be given to people with COVID based on their stage of infection and illness.”
Head of the TGA John Skerritt. Source: AAP
To this date, the TGA has not received any application to register Ivermectin for the treatment of COVID-19, the spokesperson said.
“The TGA cannot compel a company to make an application or approve a medicine in the absence of an application,” the spokesperson told The Feed.
Doctors are able to prescribe existing medicines off-label based on their own clinical judgement, according to the spokesperson.
“It is not illegal but is subject to the clinical discretion of the prescriber with consideration of the potential risks and benefits in the setting of informed consent.”
On its website, the TGA also advised against importing unapproved medicines into Australia for personal use.
“Fake products, known as counterfeits, imitate genuine products but may contain undeclared and hazardous active ingredients,” the site reads.
“Risky products, especially those sold by online sellers that do not request a doctor's prescription, can put you at serious risk of unpredictable or severe adverse reactions.”
“The TGA does not evaluate unapproved therapeutic goods for quality, safety and efficacy when imported via the Personal Importation Scheme.”
