186. Regarding Ivermectin, is this the first time in Australian history that the Federal Government has instructed the withdrawal of a medicine in the context of a public health emergency? 187. What evidence was there that taking Ivermectin could be a risk to the community either directly, or indirectly by discouraging vaccination. Given vaccination doesn’t stop transmission how was taking Ivermectin a threat to others? 188. What evidence was considered by the committee when recommending that Ivermectin was a risk to individual patient health. Did the Committee and Minister review any evidence of death or injury through inappropriate use of Ivermectin? I note Dr Skerritt stated 12mg was an unsafe dose in a previous conversation yet the sponsors of the drug have claimed that one off does of 120mg and 30,60 and 90mg doses on day 1, day 4 and day 7 are safe.

Question Number: 194
PDR Number: SQ22-000564
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 186 There was no ‘withdrawal of ivermectin”; the decision to instruct restrictions on off-label prescribing was made by a delegate of the Secretary of Health and Aged Care on the strong advice of the Advisory Committee for Medicines Scheduling. Prescribing of ivermectin is not banned, and it has not been withdrawn from use, in Australia. General practitioners (GPs) can prescribe ivermectin, but only for approved indications, which are the treatment of scabies and certain parasitic infections. Ivermectin can also be prescribed for unapproved indications, such as the prevention and treatment of COVID-19, however such off-label prescribing must be under the supervision of an appropriate specialist clinician, for example, an infectious diseases specialist. The restrictions do not prevent use of ivermectin for COVID-19 as part of a clinical trial approved by, or notified to, the TGA under the Therapeutic Goods Act 1989. There are approximately 30 substances for which medicines containing those substances cannot be prescribed by GPs but only by either a particular type of specialist or by medical practitioners who have express permission from the Secretary of their State or Territory Department of Health. Safety-based restrictions on GP prescribing through medicines scheduling have been part of the health regulatory landscape for many years.

Question 187 Most medicines when consumed at high enough amounts can be toxic. The dosage, drug form, frequency of the dose, patient age, the condition/s being treated, severity of the condition/s, and other medications being taken by the patient are all factors that are taken into account in determining the potential risks from consuming a medicine and whether this is outweighed by the benefits. The ivermectin oral tablet is approved for short-term treatment of specific conditions in which the benefits outweigh the risks. However, the prescribing of ivermectin for unapproved indications, dosages, and frequencies should be overseen by an appropriate medical specialist who can assess the relative benefits and risks for the particular patient. Oral ivermectin has the potential to cause severe adverse events, particularly when taken in the high doses that have recently been described in social media and other sources for the prevention or treatment of COVID-19 infection.

Potential adverse events from ivermectin include:
• severe skin reactions accompanied by fever, chills and aching muscles
• severe blisters and bleeding in the lips, eyes, mouth, nose and genitals
• worsening asthma
• swelling of the face, legs, ankles and feet
• nausea and vomiting
• dizziness
• seizures, and
• coma.

The Product Information document for approved indications of Ivermectin emphasises that interactions between ivermectin and other drugs have not been studied in clinical trials. This is particularly relevant to some of the treatment protocols that advocates for ivermectin use in COVID-19 have promoted. In these protocols patients received various concomitant medications (e.g. doxycycline, hydroxychloroquine, azithromycin, zinc, corticosteroids) in addition to ivermectin. These other medicines can potentially increase the ivermectin levels in the body by affecting the body’s metabolism. The ivermectin dosing schedules promoted for use in COVID-19 are not one-off doses, and are almost always higher in total dose administered than those used for treatment of parasites. While the ivermectin dose for the treatment of parasites is 3–15 mg depending on the patient’s body weight and the parasite, only a single dose of ivermectin is usually required for parasites such as onchocerciasis or strongyloidiasis while for scabies two doses are given one or two weeks apart. In contrast, the COVID-19 treatment protocols proposed doses of 12 mg (irrespective of body weight) on five consecutive days. While the 2013 Australian Public Assessment Report on ivermectin mentions administering three doses of 60, 90 and 120 mg on different days as part of clinical trials, this does not translate to a recommended dose for therapy. The focus of safety studies in these dosing trials was also more narrowly on potential central nervous system side effects. Furthermore, these doses were given to healthy young adult males who are not reflective of the majority of people who may be ill with, or seeking prophylaxis for, COVID-19.

The Database of Adverse Event Notifications includes five reports of fatal outcomes in patients taking ivermectin. Some of the medical studies on deaths following higher doses of ivermectin as well as media reports on deaths following attempts to use ivermectin to treat COVID-19 are below:
• www.thelancet.com/journals/lancet/article/PIIS0140-6736(05)62668-2/fulltext
• https://pubmed.ncbi.nlm.nih.gov/9186403/
• www.ft.com/content/9715bd16-bcb2-4bfc-bbd9-b7316d787698, and
• www.kiro7.com/news/trending/coronavirus-2-deaths-linked-ivermectin-new-mexicoofficials-say/5SZ55BRSFRDGTLJZ7ODKGZP6XI/

People who have been prescribed ivermectin may believe themselves to be protected from COVID-19 resulting in them not getting vaccinated or tested, or seeking appropriate medical care if they developed symptoms. In addition, there is significant published evidence indicating that particularly for the COVID-19 variants circulating in early-mid 2021, vaccines did have a positive impact on transmission.

Question 188 The Advisory Committee on Medicines Scheduling recommended restrictions to GP prescribing of ivermectin in response to increases in off-label prescribing for COVID-19 that posed a significant public health risk, having considered the above evidence. The potential for ivermectin to cause severe adverse events in the high dosage levels reported as being used for the treatment of COVID-19 was one aspect of the risk. Merck publicly confirmed on 4 February 2021 that to date, there is no scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies, no meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease, and a concerning lack of safety data in the majority of studies (available at: www.merck.com/news/merck-statement-on-ivermectin-use-during-the-covid-19- pandemic/).