The South African Health Products Regulatory Authority has terminated, with immediate effect, the Ivermectin-controlled compassionate use programme.
In a statement on Monday, the health authority said there is no credible evidence to support a therapeutic role for Ivermectin in Covid-19.
“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.”
In early 2021, Sahpra allowed a controlled compassionate use of Ivermectin to treat Covid-19.
Evidence from some small studies at the time suggested there was some potential benefit in the drug, as it was shown to lower viral loads and lead to faster recovery times for patients.
Sahpra said there had been several developments regarding the evidence of the efficacy of Ivermectin since the controlled compassionate use programme was adopted.
Here’s are the reasons why Sahpra has terminated the programme:
- The studies that suggested Ivermectin could be efficient to treat and prevent Covid-19 have since been retracted.
- The findings of two large clinical trials conducted in 2021 do not support the use of Ivermectin for patients with Covid-19.
- The World Health Organisation (WHO) and the United States Food and Drug Administration (FDA) issued an advisory recommending that Ivermectin can only be used within the context of clinical trials.
Sahpra said while it would continue to monitor the peer-reviewed, scientific literature regarding the safety and efficacy of Ivermectin, the scientific evidence had led to the termination of the Programme.
“The effect of these developments is that where there was equipoise at the point in time when the Programme was adopted, there is no longer equipoise.
“A further important development is that 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,” said Saphra.
In South Africa, Ivermectin is registered for use in animals. It is widely used for the control of parasites in animals and is used to treat several tropical diseases, including scabies and head lice.
Read #SAHPRA's statement on the termination of the #Ivermectin Controlled Compassionate Use Access Programme.https://t.co/Iul5XICyhX
— SAHPRA (@SAHPRA1) May 30, 2022