The South African Health Product Regulatory Authority (SAHPRA) has reiterated its stance on the use of Ivermectin for either prophylaxis or treatment of Covid-19.
On Wednesday, it released a statement saying Ivermectin was neither indicated nor approved for use in humans.
SAHPRA said studies conducted around Ivermectin were too negligible to determine its efficacy.
“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,” said SAHPRA.
To determine the efficacy of a drug, a large number of people are required, something that concerned SAHPRA when it comes to Ivermectin.
According to the Essential Medicines List, a Covid-19 sub-committee review on the overall quality of the randomised trials involving Ivermectin in Covid‐19 patients did not pass muster.
South Africans have since been warned not to use the parasiticide as a treatment for Covid-19.
This is after some South Africans took to social media to show themselves ingesting the drug, which is registered only for animal use in the country.
According to SAHPRA, the drug in South Africa was registered for use under the Fertilizers, Farm Feeds, Seeds and Remedies Act 36 of 1947, which is under the Department of Agriculture, for veterinary indications.
Although the drug was in the past authorised for the treatment of head lice and scabies, it is unlawful to use the drug outside the treatment of these.
In its statement, SAHPRA said the use of Ivermectin could lead to harmful side effects.
“It is also important to note that while ivermectin is considered generally safe, side effects include skin rash, nausea, vomiting, diarrhea, stomach pain, facial or limb swelling, neurologically adverse events [dizziness, seizures, and confusion], a sudden drop in blood pressure and liver injury [hepatitis].”