'Significant' risk to dispensing SA's unregistered Ivermectin

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Four out of five Ivermectin tablets tested in South Africa had at least one unregistered active pharmaceutical ingredient, writes MedicalBrief. This had “significant potential safety concerns for patients (and) consequent legal ramifications for the dispenser and/or prescribing doctor”, warns the small study, published in the SA Medical Journal.

The authors write that the anecdotal evidence of successful COVID19 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.

The study notes that a number of South African healthcare practitioners are promoting the prescription and use of products claiming to contain Ivermectin for the treatment and/or prevention of COVID-19 in SA, as well as There strong social media advocacy for its use. 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 are required before its use can be recommended or not.

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.

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 has become a significant source and this illegal and unregulated sourcing raises questions around the quality and the content of the ivermectin being prescribed and used.

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 samples were secured between 12 January and 3 February this year, with the suppliers found “based on information obtained from word of mouth and social media information”.The average price paid for 10 Ivermectin tablets was
R513.33.

“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.

A total of 10 different undeclared active pharmaceutical ingredients (APIs) were identified in various samples, in the analysis:
Acetaminophen, an analgesic and antipyretic;
Dicyclomine, an antimuscarinic drug that also has antispasmodic action;
Diclofenac, a non-steroidal anti-inflammatory drug used for the relief of pain and inflammation;
Hydroxyzine, a histamine H1-receptor antagonist with sedative, anxiolytic and anti-emetic properties;
Mebeverine, an antispasmodic with direct action on the smooth muscle of the gastrointestinal tract;
Nortriptyline, a tricyclic antidepressant with mild sedating effects;
Ornidazole, a nitroimidazole with the antimicrobial actions of metronidazole;
Pregabalin, an anti-epileptic used in the treatment of partial seizures, generalised
anxiety disorders and fibromyalgia with the most common adverse
events being somnolence and dizziness;
Clopidogrel, an inhibitor of platelet aggregation;
Etizolam, a short-acting benzodiazepine derivative used for the short-term treatment of insomnia and anxiety disorders.

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 COVID19 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 fact that 80% of the Ivermectin tablet formulations tested in this study contained undeclared additional APIs 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.

 

Study details
A qualitative analysis of seven Ivermectin formulations in South Africa

QE Bhorat, AE Bhorat

Published in the SA Medical Journal on 18 February 2021

Abstract
Some South African (SA) healthcare practitioners are promoting the prescription and use of products claiming to contain Ivermectin for the treatment and/or prevention of COVID-19 in SA. This study qualitatively analysed seven samples of Ivermectin formulations (5 tablet and 2 capsule formulations) being sold in SA for human use. The samples were analysed using a high-performance liquid chromatography instrument connected to a Sciex X500R quadrupole time-of-flight high-resolution mass spectrometer. The study found that all the samples had both the major homologues of Ivermectin (B1a and B1b) and also that 4 out of the 5 tablet formulations tested had at least one additional undeclared active pharmaceutical ingredient.

 

SAMJ study (Open access)

 

SAHPRA material

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