South African Health Products Regulatory Authority (Sahpra) CEO Dr Boitumelo Semete announced on Monday the termination of the use of the Ivermectin drug for the treatment and prevention of Covid-19 in South Africa.
The drug received significant worldwide public interest in 2020 as having some potential benefit in the management of Covid-19.
The Sahpra said that there was currently no credible evidence to support a therapeutic role for Ivermectin in Covid-19.
Unregistered Ivermectin products will not be allowed to be imported and health facilities will not be allowed to hold bulk stock in anticipation of prescriptions for such unregistered Ivermectin products.
However, prescribers are still expected to report on the clinical outcomes of those patients for whom treatment approval was given prior.
“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,” said Semete.
She added that although there had been several developments in Ivermectin efficacy, Covid-19 vaccines are now widely available.
The Sahpra has noted a decline in the number of health facilities applying for permission to hold bulk stock of Ivermectin since August 2021.
Sahpra said it would continue to monitor the peer-reviewed, scientific literature regarding the safety and efficacy of Ivermectin.
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