SAHPRA
The efficacy of what was once hailed as a 'miracle cure' by some for Covid-19 has been quashed by the SA Health Products Regulatory Authority (SAHPRA) following the findings of at least two large clinical trials conducted in August 2021.
In a statement on Monday night, the regulator said it had subsequently terminated its controlled access programme for Ivermectin with immediate effect.
It said there was currently no credible evidence to support a therapeutic role for Ivermectin in Covid-19.
SAHPRA spokesperson Yuven Gounden explains why it had initially approved the controlled access programme.
"At that time there were reports of illicit Ivermectin-containing products, as well as veterinary Ivermectin products being used. SAHPRA therefore enabled a controlled compassionate use-programme relying on Section 21 of the Medicines and Related Substances Act," said Gounden.
He said the situation had changed since 2021.
"Since then, studies have suggested the potential efficacy of Ivermectin has been limited and they have been retracted. The findings of two large clinical trials conducted in 2021 do not support the use of Ivermectin for patients with Covid-19.
"Given that there is currently no credible evidence to support a therapeutic role for Ivermectin in Covid-19, SAHPRA has decided to terminate the programme with immediate effect.
"No further importation of unregistered Ivermectin products will be allowed, and health facilities will no longer be enabled to hold bulk stock in anticipation of prescriptions for such unregistered Ivermectin products," he added.
SAHPRA said it would continue to monitor peer-reviewed, scientific literature regarding the safety and efficacy of Ivermectin.
