Given that there is currently no credible evidence to support a therapeutic role for ivermectin in Covid-19, the SA Health Products Regulatory Authority has decided to terminate its controlled access programme with immediate effect.
A programme permitting controlled access to ivermectin for the prevention or treatment of Covid-19 in humans has been terminated by the SA Health Products Regulatory Authority .
The “controlled compassionate use programme” granted permission 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 required after prescribers had initiated use of ivermectin. Sahpra undertook to monitor the emerging evidence of safety and efficacy, for both treatment and prevention.
The FDA said: “Even the levels of ivermectin for approved human uses can interact with other medications, like blood-thinners. You can also overdose on ivermectin, which can cause nausea, vomiting, diarrhoea, hypotension , allergic reactions , dizziness, ataxia , seizures, coma and even death.”No new applications for importation of unregistered ivermectin products have been received since August last year, said Sahpra.