The use of Ivermectin for the treatment and prevention of COVID-19 received a lot of public interest in 2020. Early evidence, mostly from studies with a small number of patients and conducted with varying degrees of scientific rigour, indicated some potential benefit in the management of COVID-19.

At the time, there were reports of illicit Ivermectin-containing products entering the South African

market, as well as the use of veterinary Ivermectin products.

In response to the demand for access to Ivermectin for human use, SAHPRA enabled a controlled compassionate use programme relying on section 21 of the Medicines and Related Substances Act. The programme was initiated in January 2021. Permission was granted to five importers of unregistered Ivermectin oral solid dosage forms, and health facilities were enabled to hold bulk stock, in anticipation of patient need. Individual named patient applications were still required after prescribers had initiated use of Ivermectin. SAHPRA also undertook to monitor the emerging evidence of safety and efficacy, for both treatment and prevention.

Since the programme was adopted however, there have been several developments regarding the evidence of efficacy of Ivermectin:

• The studies that suggested potential efficacy of Ivermectin in the prevention and treatment of

COVID-19 and which motivated the adoption of the programme have since been retracted.

• The key meta-analysis by Hill et al, upon which the proponents of Ivermectin relied, has been

retracted by the authors. This was due to serious ethical concerns regarding a study on which

the meta-analysis heavily relied.

• The findings of two large clinical trials¹ conducted in 2021 do not support the use of Ivermectin

for COVID-19 patients.

• Two national health organisations updated their guidelines and do not recommend the use of

Ivermectin in patients with COVID-19, except in the context of clinical trials.²

• The health regulatory authority of the United States, the Food and Drug Administration (FDA),

cautions against the use of Ivermectin for COVID-19, except in the context of clinical trials. The

FDA’s consumer update of 12 October 2021 states that:³

• “The FDA has not authorised or approved Ivermectin for the treatment or prevention of COVID-19 in people or animals. Ivermectin has not been shown to be safe or effective for these indications”;
• “Taking large doses of Ivermectin is dangerous”; and
• “Even the levels of Ivermectin for approved human uses can interact with other medications, like blood-thinners. You can also overdose on Ivermectin, which can cause nausea, vomiting, diarrhoea, hypotension (low blood pressure), allergic reactions (itching and hives), dizziness, ataxia (problems with balance), seizures, coma and even death.”
• Subsequent to the adoption of the programme, the World Health Organization (WHO) issued

an advisory recommending that Ivermectin only be used within the context of clinical trials.

SAHPRA has a duty to consider all the published data and the conclusions of these reputable authorities.

While there was reason to suggest the value of Ivermectin at the time the programme was adopted, this is no longer the case. In addition, vaccines for COVID-19 are now widely available. SAHPRA has made available other vaccines and therapeutics for COVID-19 through section 21 of the Act.

No new applications for importation of unregistered Ivermectin products have been received since

August 2021. A marked decline in the number of health facilities applying for permission to hold bulk

stock was noted after August 2021. No individual named patient applications have been approved

since December 2021, and a lack of reporting by the treating healthcare providers of the achieved outcomes was also noted.

The scientific evidence, as set out above, as well as the other developments summarised above has

caused SAHPRA to revise its approach to the programme in accordance with Regulation 29(4).

Given that there is currently no credible evidence to support a therapeutic role for Ivermectin in

COVID-19, SAHPRA decided to terminate the programme with immediate effect. No further

imports of unregistered Ivermectin products will be allowed, and health facilities will no longer be

able to hold bulk stock in anticipation of prescriptions for such unregistered Ivermectin products.

Prescribers will still be expected to report on the clinical outcomes achieved in patients for whom

section 21 approval has been issued.

SAHPRA will continue to monitor the peer-reviewed, scientific literature regarding the safety and

efficacy of Ivermectin.

References

1 I-TECH Randomized Clinical Trial and the Together Randomized Clinical Trial.

2 Rapid review of Ivermectin for COVID-19 Update, 30 July 2021, NEMLC Sub-committee on COVID-19; National Institute

for Communicable diseases (NICD)/National Department of Health (NDOH) guideline, Clinical Management of Suspected

or Confirmed Covid-19 Disease, December 2021.

3 https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-Ivermectin-treat-or-prevent-covid-19