Since then, Sahpra said studies that suggested potential efficacy of ivermectin in the prevention and treatment of Covid-19 have been retracted. The findings of two large clinical trials conducted in 2021 also did not support the use of ivermectin for patients with Covid-19.
The US Food and Drug Administration (FDA) in October stated: “ivermectin has not been shown to be safe or effective for these indications” and cautioned “taking large doses of ivermectin is dangerous”.
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 (low blood pressure), allergic reactions (itching and hives), dizziness, ataxia (problems with balance), seizures, coma and even death.”
A declining interest in ivermectin
No new applications for importation of unregistered ivermectin products have been received since August last year, said Sahpra.
“A marked decline in the number of health facilities applying for permission to hold bulk stock was noted after August 2021. No individual named patient applications have been approved since December 2021, and a lack of reporting by the treating healthcare providers of the outcomes achieved was also noted,” it added.
“The effect of these developments is that where there was equipoise [balance of interests] at the point in time when the programme was adopted, there is no longer equipoise.
“Given that there is currently no credible evidence to support a therapeutic role for ivermectin in Covid, 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. Prescribers will still be expected to report on the clinical outcomes achieved in patients.
Sahpra said it would continue to monitor the peer-reviewed, scientific literature regarding the safety and efficacy of ivermectin.
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Ivermectin for Covid-19 discontinued in SA amid lack of credible data, declining interest
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 (Sahpra).
There was a buzz about the product in 2020, with reports of illicit ivermectin-containing products entering SA, as well as the use of veterinary ivermectin products.
Wanting to prevent an uncontrolled situation in which people were using veterinary ivermectin in a dangerous way, in January 2021 Sahpra said clinicians could apply to use permitted human formulations for specific named patients and would be obliged to report on the outcomes.
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.
Since then, Sahpra said studies that suggested potential efficacy of ivermectin in the prevention and treatment of Covid-19 have been retracted. The findings of two large clinical trials conducted in 2021 also did not support the use of ivermectin for patients with Covid-19.
The US Food and Drug Administration (FDA) in October stated: “ivermectin has not been shown to be safe or effective for these indications” and cautioned “taking large doses of ivermectin is dangerous”.
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 (low blood pressure), allergic reactions (itching and hives), dizziness, ataxia (problems with balance), seizures, coma and even death.”
A declining interest in ivermectin
No new applications for importation of unregistered ivermectin products have been received since August last year, said Sahpra.
“A marked decline in the number of health facilities applying for permission to hold bulk stock was noted after August 2021. No individual named patient applications have been approved since December 2021, and a lack of reporting by the treating healthcare providers of the outcomes achieved was also noted,” it added.
“The effect of these developments is that where there was equipoise [balance of interests] at the point in time when the programme was adopted, there is no longer equipoise.
“Given that there is currently no credible evidence to support a therapeutic role for ivermectin in Covid, 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. Prescribers will still be expected to report on the clinical outcomes achieved in patients.
Sahpra said it would continue to monitor the peer-reviewed, scientific literature regarding the safety and efficacy of ivermectin.
TimesLIVE
Support independent journalism by subscribing to the Sunday Times. Just R20 for the first month.
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