The South African Healthcare Products Regulatory Authority (Sahpra) has warned the public not to use ivermectin drug to treat the Covid-19. The drug is used to treat parasites in animals but is currently being touted as a possible treatment for Covid-19. The warning comes at the time when countries across the globe, including South Africa, are rushing to approve vaccines to inoculate their citizens against the rampant Covid-19.
According to Sahpra, the drug works by paralysing and killing parasites in animals and is also used to treat scabies, lice and a range of tropical diseases in humans, which are not common in South Africa. Currently, ivermectin is registered for use in animals and this allows veterinarians and other trained health practitioners to prescribe it as an anti-parasitic agent for a variety of animals.
But Sahpra stressed that, although it has occasionally granted permission to use the drug as treatment for humans with scabies and lice, it is currently not registered for human use.
Sahpra released a statement recently to refute reports that the drug is used to treat the coronavirus. “Ivermectin is not indicated nor approved by Sahpra for use in humans. There is no confirmatory data on ivermectin available as yet for its use in the management of COVID-19 infections,” read the statement. The health authority body added that “in terms of safety and efficacy there is no evidence to support the use of ivermectin and we do not have any clinical trial evidence to justify its use”.
Following the growing interest in the drug, Sahpra said it has “reviewed the available data from clinical data studies”, adding that Dr Andrew Hill of the University of Liverpool conducted the systematic review. Dr. Hill concluded that well designed clinical trials are required to provide sufficient scientific data for the use of ivermectin for the treatment of COVID-19.
To date, “there have been no positive recommendations for the use of ivermectin in the management of Covid-19 infections by any regulatory authority with which Sahpra has a reliance agreements, e.g. USFDA, EMA, MHRA, among others. The WHO does not currently recommend the use of ivermectin for the treatment or prophylaxis of COVID-19 infections,” noted Sahpra.
It said it will expedite and continue to evaluate any emerging peer reviewed publications or data on the use of the drug for the treatment of COVID-19. Said Sahpra: “we will also consider enabling access to approved formulations of ivermectin intended for human use, including through Section 21 authorisation, provided such a request is supported by evidence for the indication requested and is justified based on a risk benefit assessment that includes safety and clinical efficacy data”.
US’s Federal Drug Administration, which approved the use of ivermectin in some instances, also warned against its use to treat COVID-19. The drug administration said no person should use the drug unless specifically prescribed by an authorised healthcare practitioner or obtained from a legitimate source.
Several other infectious disease experts and specialists also warned against the use of the drug. They all agreed that currently no data from credible journals or peer reviewed journals support the use of ivermectin to treat COVID-19. In addition, they pointed out that the drug was originally designed for veterinary use and there is no way it can be re-purposed for human use without undergoing the necessary scientific trials.
Meanwhile, IOL on Friday reported that a hospital manager and a pharmacist were arrested after the latter is alleged to have administered ivermectin to a patient. The duo works for the Ahmed Al-Kadi Hospital based in Mayville, KwaZulu-Natal.
This follows a raid by the police accompanied by officials from Sahpra who were tipped off about the incident. In a separate but related matter, according to the publication, a Pakistani national was arrested at King Shaka International Airport after he was found in possession of more than 2 000 ivermectin tablets in his hand luggage. He was on his way from Dubai.