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Australian imports of ivermectin increase tenfold, prompting warning from TGA

A national shortage and tenfold increase in Australians importing ivermectin in August has sparked a warning from the Therapeutic Goods Administration against the use of the medicine, which is typically used to deworm livestock, as a treatment for Covid-19.

Amid growing reports in the United States in recent weeks of people calling poison information hotlines over self-medicating with ivermectin as a treatment for Covid-19, a spokesperson for the TGA told Guardian Australia there had been a massive increase in people bringing the drug into Australia.

“The TGA works closely with the Australian Border Force to detect potentially unlawful imports of therapeutic goods for assessment by the TGA. As a result of this work, detections of ivermectin have increased significantly, more than tenfold,” a spokesperson said.

Amid the country’s largest Covid outbreak still surging in New South Wales, there was a shortage of local supply of ivermectin, which is approved for use in humans for treating issues such as river blindness and threadworm, in August, the TGA said.

“An unexpected increase in consumer demand resulted in a recent shortage of Stromectol 3mg ivermectin tablets between 2 August 2021 to 20 August 2021. This shortage has been resolved.”

The concern over the increased importation led to the TGA last week issuing a public statement against people using the drug for Covid-19 treatment.

“Ivermectin is a prescription medicine that is not approved in Australia (or in other OECD countries) to prevent or treat Covid-19 disease, and should not be imported for this indication,” the regulator said.

“The TGA strongly discourages self-medication and self-dosing with ivermectin for Covid-19 as it may be dangerous to your health. There is insufficient evidence to validate the use of Ivermectin in patients with Covid-19.”

The National Covid-19 Clincial Evidence Taskforce this month released a one-page FAQ for people considering using ivermectin as a Covid-19 treatment, stating its strong recommendation against using the drug outside of randomised clinical trials.

“As at 20 August 2021, the taskforce has concluded that there remains significant uncertainty whether ivermectin is more effective and safer than standard care in treating patients with Covid-19,” the taskforce stated.

Guardian Australia has observed people in Australian anti-vaccination groups on social media site Telegram, sharing links to online stores where people can import the drug, which doctors in Australia to obtain a prescription from, and advice on how to take the drug.

The Australian interest in ivermectin as a treatment alternative for Covid-19 has its origins from rightwing media such as Fox News and political circles in the United States.

The US Food and Drug Administration last week had to tell the public not to take the drug, as reports pointed to an increased call to poison hotlines from people who had taken ivermectin, with at least one hospitalisation.

“You are not a horse,” the FDA said in a tweet. “You are not a cow. Seriously, y’all. Stop it.”

The FDA warned side-effects from taking ivermectin could include “skin rash, nausea, vomiting, diarrhoea, stomach pain, facial or limb swelling, neurologic adverse events (dizziness, seizures, confusion), sudden drop in blood pressure, severe skin rash potentially requiring hospitalisation, and liver injury (hepatitis).

“Laboratory test abnormalities include decrease in white cell count and elevated liver tests. Any use of ivermectin for the prevention or treatment of Covid-19 should be avoided.”

As a consequence of the attention rightwing politicians and media pundits are giving the drug in the United States, the call for the drug to be used for Covid treatment has also been adopted in Australia by their local counterparts.

Sky News recently received a one-week ban from posting on its YouTube page for videos advocating for the use of experimental and unproven Covid-19 treatments such as ivermectin and hydroxychloroquine.

Aside from former Liberal MP Craig Kelly, who was banned from Facebook for among other things, promoting ivermectin, others within parliament have also been seeking answers on why the drug has not be approved in Australia.

Liberal National Party senator Gerard Rennick and One Nation Party senator Malcolm Roberts both asked the health department in Senate estimates questions about the availability of ivermectin in Australia for Covid-19.

The department said in response no application had ever been sought by anyone for the approval of the use of ivermectin for Covid-19 treatment in Australia.

“For ivermectin to be registered … by the TGA for the treatment of Covid-19, a sponsor must submit a comprehensive application to support the supply of the medicine,” the department said.

The application would need to include a dossier of clinical studies, non-clinical/toxicology studies, and other information. The department said to date the studies published on ivermectin’s use in treating Covid-19 were not compelling.

“While there are some studies published either on unreferenced websites or in second- or third-tier medical journals, the consensus view of major regulators and in top-tier international journals is that the evidence for clinical efficacy of ivermectin is not compelling at this stage.”

Source: Theguardian.com

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