Substandard and falsified ivermectin tablets obtained for self-medication during the COVID-19 pandemic as a source of potential harm.

COVID-19 antiparasitic drugs online medicines quality control substandard medicine

Journal

Drug testing and analysis
ISSN: 1942-7611
Titre abrégé: Drug Test Anal
Pays: England
ID NLM: 101483449

Informations de publication

Date de publication:
03 Dec 2023
Historique:
revised: 07 11 2023
received: 11 10 2023
accepted: 10 11 2023
medline: 4 12 2023
pubmed: 4 12 2023
entrez: 3 12 2023
Statut: aheadofprint

Résumé

In 2019, a global viral pandemic, due to the SARS-CoV-2 virus, broke out. Soon after, the search for a vaccine and/or antiviral medicine began. One of the candidate antiviral medicines tested was ivermectin. Although several health authorities warned the public against the use of this medicine outside clinical trials, the drug was widely used at the end of 2020 and in 2021. Simultaneously, several reports started to emerge demonstrating serious adverse effects after self-medicating with ivermectin. It stands to reason that the self-administration of substandard or falsified (SF) medicines bearing harmful quality deficiencies have contributed to this phenomenon. In order to have a better view on the nature of these harmful quality deficiencies, SF ivermectin samples, intercepted in large quantities by the Belgian regulatory agencies during the period 2021-2022, were analyzed in our official medicines control laboratory. None of the samples (n = 19) were compliant to the quality criteria applicable to medicinal products. These SF products either suffered from a systematic underdosing of the active pharmaceutical ingredient or were severely contaminated with bacteria, two of which were contaminated with known pathogens that cause gastrointestinal illness upon oral intake. In addition to the direct risks of self-medicating with such a product, the improper usage and dosage of ivermectin medication might also facilitate ivermectin tolerance or resistance in parasites. This may have detrimental consequences on a global scale, certainly as the number of newly developed active pharmaceutical ingredients that can safely be used to combat parasites is rather scarce.

Identifiants

pubmed: 38043940
doi: 10.1002/dta.3618
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2023 John Wiley & Sons, Ltd.

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Auteurs

Celine Vanhee (C)

Service Medicines and Health Products, Scientific Direction of Chemical and Physical Health Risks, Sciensano, Brussels, Belgium.

Bram Jacobs (B)

Service of Foodborne Pathogen, Scientific Direction of Infectious Diseases in Humans, Sciensano, Brussels, Belgium.

Angélique Kamugisha (A)

Service Medicines and Health Products, Scientific Direction of Chemical and Physical Health Risks, Sciensano, Brussels, Belgium.

Michael Canfyn (M)

Service Medicines and Health Products, Scientific Direction of Chemical and Physical Health Risks, Sciensano, Brussels, Belgium.

Hans Van Der Meersch (H)

Federal Agency for Medicine and Health Care Products, Brussels, Belgium.

Bart Ceyssens (B)

Federal Agency for Medicine and Health Care Products, Brussels, Belgium.

Eric Deconinck (E)

Service Medicines and Health Products, Scientific Direction of Chemical and Physical Health Risks, Sciensano, Brussels, Belgium.

Koenraad Van Hoorde (K)

Service of Foodborne Pathogen, Scientific Direction of Infectious Diseases in Humans, Sciensano, Brussels, Belgium.

Marie Willocx (M)

Service Medicines and Health Products, Scientific Direction of Chemical and Physical Health Risks, Sciensano, Brussels, Belgium.

Classifications MeSH