Uncovering the Quality Deficiencies with Potentially Harmful Effects in Substandard and Falsified PDE-5 Inhibitors Seized by Belgian Controlling Agencies

Vanhee, Celine; Jacobs, Bram; Mori, Marcella; Kamugisha, Angélique; Debehault, Loïc; Canfyn, Michael; Ceyssens, Bart; Van Der Meersch, Hans; van Hoorde, Koenraad; Deconinck, Eric; Willocx, Marie

doi:10.3390/forensicsci3030031

Cited by 3 publications

(2 citation statements)

References 49 publications

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“…Bioburden testing was performed as mentioned in [ 41 , 42 ]. The encountered bacteria were isolated on trypto-casein-soy agar for further analysis, while the encountered fungi were isolated on Sabouraud dextrose agar prior to downstream identification.…”

Section: Methodsmentioning

confidence: 99%

Quality Control and Safety Assessment of Online-Purchased Food Supplements Containing Red Yeast Rice (RYR)

Vanhee,

Jacobs,

Canfyn

et al. 2024

Foods

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Dietary supplements containing red yeast rice (RYR), a fermentation product of the fungus Monascus purpureus grown on white rice, remain popular in Europe as proclaimed cholesterol-lowering aids. The cholesterol-lowering effects are due to the occurrence of monacolin K, which is often present as a mixture of monacolin K lactone (MK) and as monacolin K hydroxy acid (MKA). MK is structurally similar to the cholesterol-lowering medicine lovastatin. Recently, due to safety concerns linked to the use of statins, the European Commission prohibited RYR supplements with a maximum serving exceeding 3 mg of total monacolins per day. Moreover, the amount of the mycotoxin citrinin, potentially produced by M. purpureus, was also reduced to 100 µg/kg. Evidently, manufacturers that offer their products on the European market, including the online market, must also be compliant with these limits in order to guarantee the safety of their products. Therefore, thirty-five different RYR supplements, purchased from an EU-bound e-commerce platform or from registered online pharmacies, were screened for their compliance to the European legislation for citrinin content and the amount of total monacolin K. This was conducted by means of a newly developed LC-MS/MS methodology that was validated according to ISO 17025. Moreover, these supplements were also screened for possible adulteration and any contamination by micro-organisms and/or mycotoxins. It was found that at least four of the thirty-five RYR supplements (≈11%) might have reason for concern for the safety of the consumer either due to high total monacolin K concentrations exceeding the European predefined limits for total monacolins or severe bacterial contamination. Moreover, three samples (≈9%) were likely adulterated, and the labeling of six of the seventeen samples (≈35%) originating from an EU-based e-commerce platform was not compliant, as either the mandatory warning was missing or incomplete or the total amount of monacolins was not mentioned.

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Section: Methodsmentioning

confidence: 99%

Quality Control and Safety Assessment of Online-Purchased Food Supplements Containing Red Yeast Rice (RYR)

Vanhee,

Jacobs,

Canfyn

et al. 2024

Foods

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“…The majority of hormone products circulating in the European market originate from countries within the European Union and Russia, with occasional contributions from Thailand, Turkey, Egypt, India, and Pakistan. [29][30][31] Similarly, significant volumes of anabolic steroids in the United States are sourced from Mexico, Russia, Romania, and Greece. 32 In the United Kingdom, the Misuse of Drugs Act classifies anabolic steroids under Schedule IV Part 2.…”

Section: Anabolic Steroidsmentioning

confidence: 99%

The Uses of Anabolic Androgenic Steroids Among Athletes; Its Positive and Negative Aspects- A Literature Review

Wenbo,

Yan

2023

JMDH

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The use of anabolic androgenic steroids (AAS) for strength training and muscle building is a widespread practice among athletes and young individuals. Athletes and bodybuilders are using these substances for various purposes, such as enhancing muscle mass, strengthening their bodies, and enhancing their performances. AAS exert a wide range of physiological effects that result in the activation of central signaling, resulting in adverse effects. Moreover, excessive use of AAS which can be categorized as AAS abuse; is linked to biological and psychological pathologies, which can lead to mortality. Complications arising from steroid abuse involve both cellular and physiological complications. Cellular complications arise when activation of signaling proteins like mTOR, Akt, etc. leads to alteration in protein synthesis pathways, cell cycle, oxidative stress, and apoptosis, contributing to damage at the cellular level. Physiological complications are evident with cardiovascular pathologies, including an altered lipid profile, cardiac hypertrophy, hypogonadism after discontinuation of AAS, and modulation of GABA receptors in the brain, all contributed by the androgen receptor signaling. Clinical complications budding from these altered physiological processes lead to clinical effects like testicular dysfunction, acne, gynecomastia, and neuropsychiatric disorders. Despite potential therapeutic benefits, AAS use is prohibited by the World Anti-Doping Agency (WADA) due to concerns over adverse health effects. This review highlights the molecular mechanisms, physiological processes, and clinical complications arising from the excessive use of AAS among athletes.

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

Vanhee,

Jacobs,

Kamugisha

et al. 2023

Drug Testing and Analysis

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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.

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Uncovering the Quality Deficiencies with Potentially Harmful Effects in Substandard and Falsified PDE-5 Inhibitors Seized by Belgian Controlling Agencies

Cited by 3 publications

References 49 publications

Quality Control and Safety Assessment of Online-Purchased Food Supplements Containing Red Yeast Rice (RYR)

Quality Control and Safety Assessment of Online-Purchased Food Supplements Containing Red Yeast Rice (RYR)

The Uses of Anabolic Androgenic Steroids Among Athletes; Its Positive and Negative Aspects- A Literature Review

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

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