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Restrictions placed on ivermectin use in general practice
GPs can now only prescribe the drug, which has been touted as a potential COVID cure, for TGA-approved indications.
There is limited evidence to support the use of ivermectin as a treatment for COVID-19.
The Therapeutic Goods Administration (TGA) announced the new restrictions late on Friday afternoon, following increased reports of patients and doctors seeking to use the drug as a COVID treatment and prophylaxis.
GPs are now only able to prescribe ivermectin for TGA-approved indications such as scabies and certain parasitic infections.
However, specific specialists – including infectious disease physicians, dermatologists, gastroenterologists and hepatologists – will still be permitted to prescribe the drug for other unapproved indications if they believe it is appropriate for a particular patient.
‘The TGA, acting on the advice of the Advisory Committee for Medicines Scheduling, has placed new restrictions on the prescribing of oral ivermectin,’ the TGA release stated.
‘Ivermectin is not approved for use in COVID-19 in Australia or in other developed countries, and its use by the general public for COVID-19 is currently strongly discouraged by the National COVID Clinical Evidence Taskforce, the World Health Organization and the US Food and Drug Administration.’
There has been a 3–4-fold increase in ivermectin prescriptions in Australia in recent months, while in August imports of the drug were reportedly 10 times higher than usual, prompting a warning from the TGA.
Pharmacists are also reporting a rise in customers refusing to disclose the reason for their ivermectin prescription, while a Melbourne general practice has been offering $85 ivermectin consultations.
The growing use of the medication has be fuelled primarily by anti-vaccination groups and right-wing politicians, but there is limited evidence to support its use and it can have significant side effects; Westmead Hospital recently admitted a patient following a self-inflicted ivermectin overdose that resulted in severe diarrhoea and vomiting.
According to the TGA, there are several ‘significant public health risks’ associated with taking ivermectin in an attempt to prevent COVID-19 infection rather than getting vaccinated.
‘Individuals who believe that they are protected from infection by taking ivermectin may choose not to get tested or to seek medical care if they experience symptoms. Doing so has the potential to spread the risk of COVID-19 infection throughout the community,’ the release announcing the restrictions states.
‘Secondly, the doses of ivermectin that are being advocated for use in unreliable social media posts and other sources for COVID-19 are significantly higher than those approved and found safe for scabies or parasite treatment.
‘These higher doses can be associated with serious adverse effects, including severe nausea, vomiting, [and] neurological effects such as dizziness, seizures and coma.’
The major increase in prescribing has also led to national and local shortages that are affecting patients who need the medicine for scabies and parasite infections.
‘Such shortages can disproportionately impact vulnerable people, including those in Aboriginal and Torres Strait Islander communities,’ the TGA stated.
Stromectol ivermectin 3 mg is the only TGA-approved oral ivermectin product. It is indicated for the treatment of river blindness (onchocerciasis), thread worm of the intestines (intestinal strongyloidiasis) and scabies.
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