Four out of five ivermectin tablets tested in a study published this week had “at least one” additional pharmaceutical ingredient which had not been registered.
According to the study — titled “A qualitative analysis of seven ivermectin formulations in SA” and published in the SA Medical Journal — seven samples of the drug, which was being sold for human consumption, were analysed. Of these samples, two were capsules and five were in tablet form.
“The study found that all the samples had both the major homologues of ivermectin (B1a and B1b) and also that four out of the five tablet formulations tested had at least one additional undeclared pharmaceutical ingredient,” said the study authors, Qasim Bhorat and As’ad Bhorat, of the Soweto Clinical Trials Centre.
The use of ivermectin to treat Covid-19 has become a legal hot potato, with many people — including doctors — advocating for its use.
The SA Health Products Regulatory Authority (Sahpra) said at the end of January that it would “implement a compassionate use access programme” through available legislation — and that this would also allow “much-needed data on the performance of ivermectin in South African patients” to be collected.
But the authors of the SAMJ study published this week warned that the drug may contain ingredients that were harmful.
They write: “That 80% of the ivermectin tablet formulations tested in this study contained undeclared additional APIs [active pharmaceutical ingredient] that are unknown to both the prescriber and the patient has potential safety concerns for any person who uses these formulations. Potential safety concerns include, but are not limited to, allergies, drug interactions and the side-effect profile of the relevant API.
“While ingestion of these products may raise significant potential safety concerns for patients, it may also create consequent legal ramifications for the dispenser and/or prescribing doctor of these unregistered medications.
“The safety and legal concerns of using unregistered ivermectin formulations for the treatment or prophylaxis of Covid-19 highlighted by this study are therefore important information for both prescribers and patients.”
They also found that the tablet formulations of the drugs they procured “all had labelling claiming manufacture outside SA’s borders and have therefore been illegally imported into SA and dispensed/sold/used as a potential treatment for Covid-19, thereby bypassing South African Health Products Regulatory Authority (Sahpra) registration and any other SA quality control process or check”.
“Both the ivermectin capsule formulations were compounded in SA,” they added.
The samples were secured between January 12 and February 3 this year, with the suppliers found “based on information obtained from word of mouth and social media information”.
“To date, there is no formulation of ivermectin registered or approved for human use in SA. The ivermectin formulations being used to manage Covid-19 in SA are principally from three sources: veterinary preparations, which are widely available as intravenous formulations for injection, compounding pharmacies, or illegal importation.
“Illegal importation of ivermectin pharmaceutical formulations has become a significant source of the ivermectin being sold, dispensed and used in SA. This illegal and unregulated sourcing of ivermectin raises questions around the quality and the content of the ivermectin being prescribed and used,” the authors state.
They acknowledge that there has been “strong social media advocacy for its use” to treat Covid-19.
“The current scientific evidence on the efficacy of ivermectin in the treatment and/or prophylaxis of Covid-19 remains equivocal, with recommendations that additional quality data is required before its use can be recommended or not,” said the study.
From the analysis of the seven samples, 10 different additional pharmaceutical ingredients were identified.
“Some of these APIs have properties that may play a clinical role in management of the symptoms of Covid-19 infections. Given the high percentage (57%) of ivermectin formulations shown to have additional undeclared APIs, anecdotal evidence of successful Covid-19 treatment with ivermectin formulations may be confounded by the possible intentional addition of these undeclared medications to target and alleviate Covid-19 symptoms.
“This may well contribute to the impression of efficacy in ameliorating Covid-19 symptoms, and requires further evaluation and analysis,” the study says.
TimesLIVE (TMG Digital)