SAHPRA terminates Covid-19 Ivermectin programme

SAHPRA terminates Covid-19 Ivermectin programme

The South African Health Products Regulatory Authority (SAHPRA) has terminated its controlled access programme for Ivermectin.

SAHPRA terminates Covid-19 Ivermectin programme
SAHPRA

The drug was hailed as a miracle cure by some for Covid-19, but the regulator says there is currently no credible evidence to support a therapeutic role for Ivermectin in Covid-19.


Sahpra says the findings of two large clinical trials conducted in 2021 do not support the use of Ivermectin, and thus the studies that suggested the potential efficacy of the drug in the prevention and treatment of Covid-19 have been retracted.


SAHPRA spokesperson Yuven Gounden says scientific evidence has caused it to revise its approach to the clinical programme.


"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."


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"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.

 

"Prescribers will still be expected to report on the clinical outcomes achieved in patients for whom section 21 approval has been issued."


The health regulatory authority of the United States, the Food and Drug Administration (FDA), has also cautioned against the use of Ivermectin for Covid-19, except in the context of clinical trials as recommended by the World Health Organisation.

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