Nelson Vergel
Founder, ExcelMale.com
Some products for sexual enhancement augment sexual activity, but the labeled ingredients may not be the source of the effect. Of the 232 drug recalls by the US Food and Drug Administration (FDA) between 2007 and 2012—all for unlabeled drug ingredients—51% were dietary supplements. Of the dietary supplement products recalled, sexual enhancement products were the most commonly recalled (40%), followed by bodybuilding (31%) and weight-loss products (27%).[7]
Of the 1560 Health Safety Alerts for dietary supplements issued by the FDA MedWatch and Health Canada between 2005 and 2013, 33% were for sexual enhancement products.[8]
Unlabeled drugs in sexual enhancement products are frequently the prescription-only phosphodiesterase 5 (PDE5) inhibitors, such as sildenafil (Viagra®), tadalafil (Cialis®), vardenafil (Levitra®), and avanafil (Stendra®). With increasing frequency, the unlabeled drugs may be analogues of PDE5 inhibitors that have been modified slightly from the parent structures. These derivatives are not detected by routine laboratory screening, which reduces the risk for both detection by the FDA and lawsuits for patent infringement.[9] To date, more than 50 unapproved analogues of prescription PDE5 inhibitors have been identified.[10]
Recent assays performed on sexual enhancement products support the frequency of product adulteration. Of 91 products analyzed, 74 (81%) contained PDE5 inhibitors, including tadalafil and/or sildenafil (n = 40) or PDE5-inhibitor analogues (n = 34). Of the products containing prescription ingredients, 18 contained more than 110% of the highest approved drug product strength.[11]
Another study of 150 sexual enhancement products (eg, Evil Root, Herbal Stud, Magic Sex, ULTRASize) found 61% of the products were adulterated with PDE5 inhibitors: 27% with sildenafil, tadalafil, or vardenafil, and 34% with similar structural analogues. Among the adulterated products, 64% contained only one PDE5 inhibitor and 36% contained mixtures of two to four PDE5 drugs or analogues. The amounts of PDE5 inhibitor prescription medicines were higher than the maximum recommended dose in 25% of products.[8] Unlabeled yohimbine, flibanserin (Addyi™, which was recently approved by the FDA for female sexual dysfunction), phentolamine, DHEA, and testosterone also were found in some supplements.
http://www.medscape.com/viewarticle/853044?src=wnl_edit_tpal&uac=63518CJ#vp_2
Of the 1560 Health Safety Alerts for dietary supplements issued by the FDA MedWatch and Health Canada between 2005 and 2013, 33% were for sexual enhancement products.[8]
Unlabeled drugs in sexual enhancement products are frequently the prescription-only phosphodiesterase 5 (PDE5) inhibitors, such as sildenafil (Viagra®), tadalafil (Cialis®), vardenafil (Levitra®), and avanafil (Stendra®). With increasing frequency, the unlabeled drugs may be analogues of PDE5 inhibitors that have been modified slightly from the parent structures. These derivatives are not detected by routine laboratory screening, which reduces the risk for both detection by the FDA and lawsuits for patent infringement.[9] To date, more than 50 unapproved analogues of prescription PDE5 inhibitors have been identified.[10]
Recent assays performed on sexual enhancement products support the frequency of product adulteration. Of 91 products analyzed, 74 (81%) contained PDE5 inhibitors, including tadalafil and/or sildenafil (n = 40) or PDE5-inhibitor analogues (n = 34). Of the products containing prescription ingredients, 18 contained more than 110% of the highest approved drug product strength.[11]
Another study of 150 sexual enhancement products (eg, Evil Root, Herbal Stud, Magic Sex, ULTRASize) found 61% of the products were adulterated with PDE5 inhibitors: 27% with sildenafil, tadalafil, or vardenafil, and 34% with similar structural analogues. Among the adulterated products, 64% contained only one PDE5 inhibitor and 36% contained mixtures of two to four PDE5 drugs or analogues. The amounts of PDE5 inhibitor prescription medicines were higher than the maximum recommended dose in 25% of products.[8] Unlabeled yohimbine, flibanserin (Addyi™, which was recently approved by the FDA for female sexual dysfunction), phentolamine, DHEA, and testosterone also were found in some supplements.
http://www.medscape.com/viewarticle/853044?src=wnl_edit_tpal&uac=63518CJ#vp_2
