Towards a decade of detecting new analogues of sildenafil, tadalafil and vardenafil in food supplements: A history, analytical aspects and health risks

Venhuis, Bastiaan J.; Kaste, D. de

doi:10.1016/j.jpba.2012.02.014

Cited by 156 publications

(118 citation statements)

References 80 publications

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“…sildenafil), their numerous approved and unapproved analogues, synthetic intermediates, and derivatives 16, 17. Their functionality is manifested by selective inhibition of phosphodiesterase type 5 enzyme (PDE5), which hydrolyzes cyclic guanosine 3,5‐monophosphate (GMP).…”

Section: Dietary Supplements Health and Education Act (Dshea) Good Mmentioning

confidence: 99%

Dietary supplements quality analysis tools from the United States Pharmacopeia

Sarma

Giancaspro

Venema

2016

Drug Testing and Analysis

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The United States Food and Drug Administration (FDA) issued the dietary supplement (DS) current good manufacturing practice (GMP) regulations in compliance with the mandate from the Dietary Supplements Health and Education Act (DSHEA), with the intention of protecting public health by ensuring the quality of DS. The GMP regulations require manufacturers to establish their own quality specifications for identity, purity, strength, composition, and absence of contaminants. Numerous FDA‐conducted GMP inspections found that the private specifications set by these manufacturers are often insufficient to ensure adequate quality of dietary ingredients and DS. Wider use of the public standards developed by the United States Pharmacopeial Convention (USP), in conjunction with GMP compliance, can help ensure quality and consistency of DS as they do for medicines. Public health protection could be enhanced by strengthening the GMP provisions to require conformance with relevant United States Pharmacopeia–National Formulary (USP–NF) standards, or in the absence of USP standards, other public compendial standards. Another serious concern is the presence of synthetic drugs and drug analogues in products marketed as DS. Use of the new USP General Chapter Adulteration of Dietary Supplements with Drugs and Drug Analogs <2251> may reduce the exposure of consumers to dangerous drugs disguised as DS. © 2016 The Authors. Drug Testing and Analysis published by John Wiley & Sons Ltd.

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Section: Dietary Supplements Health and Education Act (Dshea) Good Mmentioning

confidence: 99%

Dietary supplements quality analysis tools from the United States Pharmacopeia

Sarma

Giancaspro

Venema

2016

Drug Testing and Analysis

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“…There are more than 50 analogues of these products with minor structural modifications that may have the same desired pharmacological properties [30,31]. Since many of these analogues are difficult to detect and never went through the thorough preclinical and clinical studies needed for market authorization, their toxicity is unknown, thus becoming a serious safety concern to the public [31].…”

Section: Abbreviationsmentioning

confidence: 99%

“…Since many of these analogues are difficult to detect and never went through the thorough preclinical and clinical studies needed for market authorization, their toxicity is unknown, thus becoming a serious safety concern to the public [31]. Gilard et al [32] believe that the combination of 1 H NMR and mass spectroscopy is the easiest method to detect these analogues.…”

Section: Abbreviationsmentioning

confidence: 99%

Untitled

2016

Planta Med

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“…[12][13][14] The analogs generally display minor structural alterations to their approved correlative drug compounds while retaining the active moiety. [15] The analogs are not declared on the labeling, and little to no information is available regarding their toxicological or pharmacological effects, which presents a danger to public health. Regulatory agencies are becoming increasingly more skilled at detecting and identifying PDE-5 inhibitor analogs in these products.…”

Section: Introductionmentioning

confidence: 99%