Toxicological evaluation of a dietary supplement formulated for male sexual health prior to market release

Clewell, Amy E.; Qureshi, Irfan A.; Endres, John R.; Horváth, János; Financsek, I.; Neal-Kababick, James; Jade, K.A.; Schauss, Alexander G.

doi:10.1016/j.yrtph.2009.12.006

Cited by 11 publications

(9 citation statements)

References 22 publications

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“…In its majority, the pulp of Euterpe oleracea is used as an additive due to its high antioxidant activity, leading to an increased product shelf life. In a study performed by Clewell et al (2010), the analysis of a pharmaceutical product named 112 Degress™, reveals that it contains in ts formulation the following ingredients: amino acid L-tyrosine; and the herbs Euterpe oleracea fruit, Tribulus terrestres seed extract, Panax ginseng root extract,…”

Section: Pharmaceutical and Functional Applicationsmentioning

confidence: 99%

Amazon acai: Chemistry and biological activities: A review

et al. 2015

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Section: Pharmaceutical and Functional Applicationsmentioning

confidence: 99%

Amazon acai: Chemistry and biological activities: A review

et al. 2015

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“…The freeze dried açai fruit pulp was used in a formulation for the erectile dysfunction. An increase in the time of shelf life of this product was observed (Clewell et al, 2010). Tablets and açai capsules can be found in the market.…”

Section: Pharmaceutical Forms and Foods Based On Açaimentioning

confidence: 72%

Euterpe oleracea Mart. (aai): an old known plant with a new perspective

Silva¹,

Assis²,

Prada³

et al. 2016

Afr. J. Pharm. Pharmacol.

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The açai (Euterpe oleracea Mart) fruit pulp is extensively used in Brazil as food among other uses. The health benefits of açai are largely reported by the Amazon inhabitants. Nonetheless, just a few pharmacological and toxicological studies were made to probe the innocuousness and the safety of the use of this product. The aims of this work were to update knowledge about the chemical composition, pharmacological and toxicological studies of the fruits and to identify possible vacuum of knowledge in the use, evaluation, and characterization of E. oleracea Mart (Açai) as a promising Amazon superfruit. It was made a draw out internet revision, especially in databases as NCBI, SCOPUS, PUBMED, SCIELO, and ELSEVIER by using the keywords E. oleracea, açai, nutraceuticals and food supplementations. Also, it was looked for each one of the ethnobotanical uses reported for this plant species combined with the first keywords. A complete record of the chemical composition of this species was achieved. Just two studies in humans were found in the literature using the açai fruit pulp. There is no sufficient systematic evidence to assure that all of the ethnobotanical uses of this species are true. A great emptiness of scientific knowledge related to the real benefits of this plant species exist. There exist neither pharmaceutical forms nor standardized product derived from the açai fruit. Until now, the number of scientific studies that allow the validaton of the ethnopharmacological practices, the innocuousness and the safety of the use of this plant fruit is insufficient.

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“…A revisão realizada por Chhatre et al (2014) descreveu diferentes propriedades farmacológicas para T. terrestris, não havendo relatos sobre efeitos adversos, assim como não foram encontrados outros trabalhos disponíveis (22). Efeitos tóxicos não foram observados na ingestão do suplemento alimentar contendo T. terrestris (23) e análises realizadas em preparações Ayurvedicas contento T. terrestris mostraram que seu uso é seguro (24).…”

Section: Resultsunclassified

Farmacovigilancia De Fitoterápicos Em Uma Indústria Farmacêutica Brasileira: Mecanismo De Aperfeiçoamento Dos Produtos

Abreu

Moura

2014

Infarma

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The use of herbal medicines is based on popular traditions and considered a therapeutic alternative to the use of official medicine. Incorrectly, the use of these medications is considered as exempt from adverse reactions. However, it may cause harmful effects if used with no proper guidance. After been released in the market, drugs may cause unexpected adverse reactions, making necessary pharmacovigilance work. This study aimed to investigate cases of adverse reactions registered for herbal medicines from a Brazilian pharmaceutical industry. Therefore, a descriptive, retrospective, cross-sectional and quantitative study was carried out for a period of eighteen months, through a database of spontaneous reports of unexpected events for herbal medicinnes produced by the mentioned industry. During the evaluation period, thirty-two notifications were registered, distributed among six herbal medicines containing: Trifolium pratense L, Pinus pinaster Aiton, Hedera helix L., Tribullus terrestris L., Pelargonium sidoides DC., Cimicifuga racemosa (L.) Nutt. The most reported adverse reaction, regardless of plant species, was allergy. People above fifty years old were responsible for most reports, originated mainly from Brazilian southeastern region. It was possible to conclude that most herbal medicines produced and distributed by the pharmaceutical laboratory involved in this study can be considered safe and effective for the treatment of diseases which they are designed to. In order to guarantee better contact between the notifier and the prescriber, it is important to disclose pharmacovigilance of herbal medicines among health workers. In this sense, it is possible to know the probable harmful effects, allowing actions to improve the product, ensuring its efficacy and safety.

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Toxicological evaluation of a dietary supplement formulated for male sexual health prior to market release

Cited by 11 publications

References 22 publications

Amazon acai: Chemistry and biological activities: A review

Amazon acai: Chemistry and biological activities: A review

Euterpe oleracea Mart. (aai): an old known plant with a new perspective

Farmacovigilancia De Fitoterápicos Em Uma Indústria Farmacêutica Brasileira: Mecanismo De Aperfeiçoamento Dos Produtos

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