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Authorities are clamping down on the dispensing of Ivermectin, which is being touted as a COVID-19 “miracle drug”, following concerns that an underground market may soon emerge.

The South African Health Products Regulatory Authority (SAHPRA) is warning the public against using the drug to treat COVID-19, as it has not been approved for use in humans.

Ivermectin is a widely used drug for the treatment and control of parasites in animals and is used to treat several tropical diseases in humans not commonly seen in South Africa, as well as scabies and head lice.

In South Africa, Ivermectin is registered for use under Act 36 of 1947 (Department of Agriculture) for use in animals. This means that veterinarians and other trained personnel are allowed to prescribe it as an anti-parasitic agent for a variety of animals. The drug is not currently registered for human use, but SAHPRA occasionally grants Section 21 permits for the use of topical ivermectin as an unregistered product for the treatment of individual patients with conditions such as scabies or head lice.

SAHPRA notes that while Ivermectin is considered generally safe, side-effects include skin rash, nausea, vomiting, diarrhoea, stomach pain, facial or limb swelling, neurologic adverse events (dizziness, seizures, and 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 enzymes.

On December 22, SAHPRA said that “Ivermectin is not indicated nor approved by SAHPRA for use in humans. There is no confirmatory data on Ivermectin available as yet for its use in the management of COVID-19 infections. In terms of safety and efficacy there is no evidence to support the use of ivermectin and we do not have any clinical trial evidence to justify its use.”

SAHPRA reports that to date, there have been no positive recommendations for the use of ivermectin in the management of COVID-19 infections by any regulatory authority with which SAHPRA has reliance agreements, e.g. USFDA, EMA, MHRA, etc., and that the WOrld Health Organisation (WHO) does not currently recommend the use of ivermectin for the treatment or prophylaxis of COVID-19 infections.

Furthermore, a report on the pharmacokinetics of ivermectin concluded that: “Preliminary findings suggest that standard doses of ivermectin would not result in efficacious concentrations, and that extraordinary doses to achieve efficacious concentrations may result in unacceptable toxicity in COVID-19 patients.”

Despite all of this, reports continue to emerge of people using the drug. A 43-year-old man who entered the country from Dubai was arrested at King Shaka International Airport for being in possession of almost 2500 ivermectin tablets.

The Ahmed Al-Kadi Hospital in Durban also came under fire, after tipoffs revealed a pharmacist was dispensing the drug to a patient for free.

“We collected evidence and we confronted the hospital with this evidence. This happened on 7 January. It was a joint operation with the South African Police Service, eThekwini Metro and Organised Crime. We confronted the responsible pharmacist and he admitted he had dispensed the drug and this was confirmed by the hospital manager,” SAHPRA said in a statement.

“SAHPRA will furthermore report the matter to the pharmacy council. The investigation into the doctors who prescribed it is ongoing and once this has been concluded, it will be reported to the HBCSA.”

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