It would be “professional misconduct” for a health practitioner or pharmacist to prescribe animal drug ivermectin to humans to treat Covid-19.
This is according to co-chair of the Ministerial Advisory Committee (MAC) Prof Salim Abdool Karim, who was speaking to eNCA on Tuesday night.
The drug — which is registered in SA under the Fertilisers, Farm Feeds, Agricultural Remedies and Stock Remedies Act — has been touted as being effective to prevent and cure Covid-19.
According to the SA Health Products Regulatory Authority (SAHPRA), ivermectin is widely-used for the treatment and control of parasites in animals, and is used to treat several tropical diseases in humans not commonly seen in SA, as well as scabies and head lice.
Abdool Karim said people were “clutching at straws” in thinking it was effective against Covid-19, and the evidence was flimsy at best that the drug could combat the coronavirus.
The renowned epistemologist compared the use of ivermectin to how people latched on to other drugs — hydroxychloroquine and artemisinin in particular — during the first wave of Covid-19 as an act of despair.
“One of the things that happens when the cases start going up, when people begin to see family members, friends getting infected and dying, is they get this sense of frustration and helplessness. ‘What’s going on here? I need a medical cure.’
I equivocally do not support the use of ivermectin at this time. There are several trials under way, some of them well conducted, so we’ll wait to get those results. Until then, ivermectin that’s available in the country is for animal use only.
— Prof Salim Abdool Karim
“And I saw in the first wave how desperate people were for a medical cure. Within days they wiped out and bought every bit of hydroxychloroquine in every pharmacy. I was getting calls and letters from people wanting to know why aren’t we using artemisinin, which is a miracle cure from Madagascar. Why aren’t we providing it to the people?” he said.
However, much like in those cases, he is adamant that ivermectin should not be prescribed for human use.
“I equivocally do not support the use of ivermectin at this time. There are several trials under way, some of them well conducted, so we’ll wait to get those results. Until then, ivermectin that’s available in the country is for animal use only.”
According to a MAC report dated January 7, there is “insufficient evidence at this stage to support the routine use of ivermectin for either the prevention or treatment of Covid-19”.
It said that while the use of the drug to prevent Covid-19 had “generated significant global interest”, because there was “limited evidence of efficacy and safety, as well as appropriate dosing ... its place in therapy and prophylaxis remains uncertain at this point”.
The MAC said physicians were “grasping at any option which promises positive results”.
“Ivermectin is being portrayed, despite the lack of high-quality evidence, as one such option. It has therefore been observed that unregulated use of ivermectin is evident in SA and increasing. No ivermectin-containing medicine for human use is registered in SA,” the report, signed by Abdool Karim and Prof Marian Jacobs, the co-chairs of the committee, reads.
Like the MAC, the SAHPA guidelines on the use of the drug says there was insufficient evidence available to recommend its use in humans.
The authority also warned that its use could be harmful to humans.
“It is also important to note that while ivermectin is considered generally safe, side-effects include skin rash, nausea, vomiting, diarrhoea, stomach pain, facial or limb swelling, neurologic adverse events (dizziness, seizures and confusion), sudden drop in blood pressure, severe skin rash potentially requiring hospitalisation and liver injury (hepatitis). Laboratory test abnormalities include decrease in white cell count and elevated liver tests,” its guidelines read.
However, the MAC acknowledged that there was “some in vitro evidence that ivermectin has antiviral activity against SARS-CoV-2”.
“Ivermectin has been used, at various doses and in combination with other medicines, in a number of clinical studies, both observational and randomised. The currently available data have been reviewed by the National Essential Medicines Committee Covid-19 Subcommittee and by SAHPRA, but are considered insufficient to justify safe use in clinical practice at this point.
“More data is required from adequately powered, well-designed randomised clinical trials to demonstrate the efficacy and safety of ivermectin in both treatment and prevention of Covid-19. Some larger trials are ongoing, and it is hoped the results will become available within the first quarter of 2021,” the report reads.
The MAC noted, though, that ivermectin was being widely promoted for the treatment and/or prevention of Covid-19.
“There are numerous anecdotal reports from general practitioners and pharmacists of the widespread prescribing and sale of ivermectin for these purposes. Different dosages and dosage forms are being used, including those compounded from available veterinary products. No meaningful clinical data can be collected from this type of unregulated, off-label use. The vast majority of patients with Covid-19 will recover without specific pharmacological treatment,” it says.
At the same time, however, reports were received of “apparent toxicity from overdoses of ivermectin”. “Though portrayed as safe, ivermectin is associated with a range of adverse effects when used in its registered indications in humans.
“Until more robust evidence is available, the routine use of ivermectin for either the prevention or treatment of Covid-19 is not justified. Nonetheless, emerging evidence must be sought and carefully reviewed. Reports of clinical trials of ivermectin for the prevention or treatment of Covid-19 must be closely watched, as they become available. Unregulated distribution channels are at risk of the introduction of substandard and falsified products, which can be deleterious to human health,” the report concludes.
