Outbreak of Severe Hypoglycemia After Ingestion of a Male Enhancement Supplement — Virginia, August–November 2019

Ross, Jennifer A.; Downs, John W; Bazydlo, Lindsay A.L.; Bordwine, Paige; Gineste, Catherine E; Kopatic, Marissa C; Rege, Saumitra V.; Saady, Dawn M; Utah, Okey; Wyatt, Shane A.; Wills, Brandon K.; Rose, S. Rutherfoord; Holstege, Christopher P.

doi:10.15585/mmwr.mm6924a3

Cited by 8 publications

(8 citation statements)

References 4 publications

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“…One is its adaptability as new substances can be added later to the existing panel if judged relevant in view of clinical practice. Another advantage is the possibility of screening yohimbine and glibenclamide, 2 other usual adulterants in sexual enhancement supplements as previously described [25,43–48], but which were absent in our patient. A third one, very crucial, is that this method is part of our routine toxicological analyses, allowing quickly available results for clinicians.…”

Section: Clinical Consequencesmentioning

confidence: 82%

“…The issue of adulteration of sexual enhancement products with both a PDE5‐i and glibenclamide is persistent and crosses the World areas. Indeed, 11 years after the Singapore and Australian cases, another similar case series was reported in the USA (Virginia State) [43]. It was about 17 non‐diabetic men aged from 33 to 73 years presenting prolonged hypoglycaemia with brain involvement within the 48 h following the ingestion of the sexual enhancement supplement marketed as V8.…”

Section: Clinical Consequencesmentioning

confidence: 89%

“…This is concerning since such undetected substances also expose consumers to risks of adverse health effects, as their pharmacological and toxicological profiles are totally unknown. Risks are increased when supplements contain a mixture of two or more PDE5-is [7,10,17,36] or even other substances such as hypoglycaemic agents [43][44][45][46][47][48].…”

Section: The Inventiveness Of Manufacturersmentioning

confidence: 99%

“…Severe hypoglycaemia related to adulterated sexual enhancement supplements Few case series of life-threatening hypoglycaemia with brain involvement due to adulteration of sexual enhancement supplements with both PDE5-is and glibenclamide, a long-acting sulfonylurea oral hypoglycaemic agent, have also been published [43][44][45][46][47][48].…”

Section: L I N I C a L C O N S E Q U E N C E Smentioning

confidence: 99%

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Drug adulteration of sexual enhancement supplements: a worldwide insidious public health threat

Yéléhé‐Okouma

Pape

Humbertjean

et al. 2021

Fundamemntal Clinical Pharma

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Worldwide, the consumption of dietary supplements for the enhancement of sexual performance is common. Consumers are generally fond of these products because they often want to avoid drugs, preferring “natural” than “chemical” solutions. This is challenging, as many of these supplements labelled “herbal” or “natural” are actually adulterated with drugs, mainly phosphodiesterase‐5 inhibitors. This phenomenon is facilitated by fewer demanding regulations for marketing supplements. Thus, consumers may be widely exposed to serious adverse events, such as acute liver injury, kidney failure, pulmonary embolism, stroke or even death. We aim to warn physicians about this issue. This multidisciplinary review simultaneously deals with clinical consequences of this phenomenon, analytical toxicology and regulation. Indeed, after outlining this worldwide issue and highlighting that a drug‐adulterated dietary supplement is actually a falsified drug, we discuss its main contributing factors. Then, we describe some examples of adverse events of which a case of sildenafil–tadalafil‐induced ischaemic stroke that benefited medical care in our hospital. Furthermore, we present some means to avoid adulteration and discuss their limitations that may be explained by the heterogeneity of the regulation of dietary supplements between countries. Doing so, we point out the requirement of a global harmonization of this regulation for an efficient eradication of this public health threat. Meanwhile, dietary supplements should be considered adulterated until proven otherwise. Thus, we encourage physicians to investigate these products in the drug histories of their patients, especially when clinical conditions cannot be explained by classical aetiologies.

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Section: Clinical Consequencesmentioning

confidence: 82%

Section: Clinical Consequencesmentioning

confidence: 89%

Section: The Inventiveness Of Manufacturersmentioning

confidence: 99%

Section: L I N I C a L C O N S E Q U E N C E Smentioning

confidence: 99%

See 2 more Smart Citations

Drug adulteration of sexual enhancement supplements: a worldwide insidious public health threat

Yéléhé‐Okouma

Pape

Humbertjean

et al. 2021

Fundamemntal Clinical Pharma

View full text Add to dashboard Cite

show abstract

“…This cluster of AE reports led to seizure of this product from retail outlets and a national public health alert through the FDA MedWatch program. A warning that dietary supplements may contain prescription medications and can cause serious morbidity is reiterated ( Ross et al, 2020 ) [S].…”

Section: V8mentioning

confidence: 99%