Controversial drug no longer permitted for use against Covid
The use of ivermectin to treat Covid has been terminated by the medicines regulator.
The South African Health Products Regulatory Authority (SAHPRA) announced on Monday that the special dispensation granted for the use of ivermectin has been terminated, after a review of evidence.
SAHPRA states that “there is currently no credible evidence to support a therapeutic role for Ivermectin in Covid”. It cites a surfeit of evidence supporting the opinion that ivermectin is of no clinical use for the prevention or treatment of Covid.
Last year, ivermectin was at the centre of an international storm when it was touted as a magic bullet for the prevention and treatment of Covid.
As GroundUp reported at the time, researchers had found some grounds for optimism across a series of studies. At a time when access to vaccines was far from guaranteed, there was an understandable clamour to test many different treatments, even unlikely ones.
But the drug – which is excellent for the treatment of parasitic worms – quickly became politicised.
Afriforum launched a court campaign to force SAHPRA to approve the use of ivermectin for Covid.
In January 2021, SAHPRA settled with Afriforum. Under the terms of the settlement, ivermectin was made available to anyone who applied to use it under SAHPRA’s section 21 process.
As noted in SAHPRA’s statement, the hype around ivermectin has vanished. Since August 2021, there has been a “marked decline” in the number of healthcare facilities applying to hold ivermectin, and there have been no approved individual applications to use ivermectin since December. SAHPRA also noted a lack of reporting on the outcomes of ivermectin treatment from healthcare providers (which is required in terms of the settlement agreement).
With the termination of the programme, importing unregistered ivermectin products will not be allowed; and health facilities will not be allowed to hold bulk stock of unregistered ivermectin products. Doctors who have prescribed ivermectin for Covid will still be expected to report to SAHPRA on the outcomes of the treatment.
Ivermectin and Covid-19: Why it’s promising but why we need to be cautious
While several studies have shown promising results there is not yet enough data for regulatory authorities to approve ivermectin
- There is a clamour by some people for ivermectin to be approved for treating Covid-19.
- While some studies show promising results, there is not yet enough data for regulatory authorities to approve its use for Covid.
- The system for approving drugs is cautious because there have been drugs in the past that seemed promising but turned out to be dangerous.
There is a clamour by some people for ivermectin to be approved by the South African Health Products Regulatory Authority (SAHPRA) to treat Covid-19. An article published on Tuesday in the South African Medical Journal (SAMJ) titled Ivermectin for COVID-19: Promising but not yet conclusive, written by six Tygerberg Hospital and Stellenbosch University clinicians and scientists, explains the current status of the drug.
Ivermectin is an anti-parasitic drug, which has been used against a range of parasitic conditions, in humans and animals. In South Africa, SAHPRA has granted access to unregistered ivermectin in cases of resistant scabies, but the drug is not approved for human use in this country. SAHPRA, according to the SAMJ article, has said that the drug may not be used except in “well-designed, ethically approved scientific studies”.
SAHPRA has indicated it will consider individual applications for pre-approval use of the drug.
The South African Department of Health issued a summary of evidence on ivermectin in December, stating: “The overall quality of the randomized trials involving ivermectin in Covid-19 patients is extremely low”. It also says: “From the available randomised control trial evidence, ivermectin is not superior to placebo in terms of viral load reduction or clinical progression. There is no evidence from randomised control trials for any reduction in mortality.” (We highly recommend reading this report. It’s well written.)