Sexual Enhancement Products Research Articles

Cross-Sectional Survey of Adulterated Sexual Enhancement Products Sold in the Sacramento Area of California

Cross-Sectional Survey of Adulterated Sexual Enhancement Products Sold in the Sacramento Area of California

Development of a detector tube for screening tadalafil and its analogues in adulterated sexual enhancement products.

Sexual enhancement products adulterated with phosphodiesterase 5 inhibitors (PDE-5i) pose a serious public health concern. Tadalafil and its analogues (Tds) are PDE-5i frequently detected as adulterants. In this study, a Td detector tube for the rapid detection of Tds was developed based on the color change reaction between sulfuric acid and Tds. The specificity of this test method was evaluated using 13 Tds, all of which elicited positive results. Additionally, 30 commonly found adulterants in dietary supplements, 11 active pharmaceutical ingredients of psychotropic drugs and 18 food ingredients were tested and obtained no false-positive results, except levomepromazine. The test tube accurately detected the presence or absence of Tds in 54 commercially available products. The visual detection limit was 2-50 and 5-20 μg/ml for Tds and tadalafil-spiked samples with matrix, respectively. The applicability of the developed detector tube to a semiquantitative test using digital image analyses were investigated using red, green, and blue color values. The results of the recovery test suggested that the tube test was affected by the dark-colored matrix. The results of semiquantitative analyses of tadalafil for five marketed products were consistent with the liquid chromatographic quantification results, except for the blue value. The detector tube developed in this study can facilitate with the rapid screening of Tds in adulterated sexual enhancement products.

Recent applications of phosphodiesterase (PDE5) inhibition assays for detecting adulterated sexual enhancement products.

Consumer products marketed for sexual enhancement are frequently adulterated with erectile dysfunction (ED) drugs and analogs; consuming these undisclosed adulterants can pose significant health hazards. Although ED drugs/analogs have unpredictable and diverse structures that pose challenges for detecting them, they all share the ability to inhibit phosphodiesterase-5 (PDE5) activity, a pharmacological mechanism responsible for their effects. Consequently, several PDE5 inhibition assays have been recently applied as screening methods to detect ED drug/analogs in products. Here, the successes and challenges are highlighted for screening sexual enhancement products by PDE5 inhibition assays.

Development and validation of HPLC/DAD method for simultaneously determination of six prohibited substances in model matrices

The authorities have identified an emerging trend where over-the-counter products, represented as dietary supplements, contain hidden active ingredients that could be harmful. Consumers may unknowingly take products laced with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients. Hidden ingredients are increasingly becoming a problem in products promoted for sexual enhancement, weight loss, or bodybuilding. The tests have revealed the presence of some undesired substances like sildenafil, tadalafil, vardenafil, and their analogues in tainted sexual enhancement products. The content of these substances is usually around the daily curative dose. A simple high-performance liquid chromatography (HPLC) method for simultaneously determination of sildenafil, vardenafil, tadalafil, dapoxetine, yohimbine, and sibutramine was developed and validated. InfinityLab Poroshell 120 EC-C18 (150 '4.6 mm '4 μm particles) was used, as well as a diode-array detector (DAD) at 230 nm, and a gradient flow with 0.030 М ammonium acetate buffer and acetonitrile. The method is linear in the following range: 2.5–37.5 μg/mL for yohimbine, 2.06–30.9 μg/mL for vardenafil, 2.0–30.0 μg/mL for sildenafil, 3.1–46.5 μg/mL for tadalafil, 1.98–29.7 μg/mL for dapoxetine, and 2.2–66.0 μg/mL for sibutramine. The linearity coefficient is R2 = 1 for all substances. Model matrices were spiked, and the analytical recoveries for all substances are in the range 97.5%–99.5%. The method exhibited an upper hand compared with previously reported methods in terms of speed and simplicity. Additionally, the mobile phase (also used as extracting, column washing, and diluting solvent) was composed of only buffer and acetonitrile, which rendered the method much cheaper than others.

Multi-Class Determination of 64 Illicit Compounds in Dietary Supplements Using Liquid Chromatography-Tandem Mass Spectrometry.

In this work, liquid chromatography–tandem mass spectrometry (LC-MS/MS) method was developed and validated for screening and confirmation of 64 illicit compounds in dietary supplements. The target compounds were illegally used pharmaceutical drugs, prohibited compounds, and not authorized ingredients for different therapeutics (sexual enhancement, weight loss, muscular strengthening, and relaxing products). The validation procedure was performed to evaluate selectivity, linearity, limit of detection (LOD), limit of quantification (LOQ), accuracy, and precision according to the Association of Official Analytical Chemists guidelines. The linearity was >0.98 in the range of 0.5–200 µg L−1. The LOQs were in the range 1–10 µg kg−1 for all target compounds. The accuracy (expressed as recovery) was 78.5–114%. The precision (expressed as the relative standard deviation) was below 9.15%. The developed method was applied for the determination of illicit compounds in dietary supplements collected from websites. As a result, the total detection rate was 13.5% (27 samples detected in 200 samples). The concentrations of detected samples ranged from 0.51 to 226 mg g−1. The proposed methodology is suitable for monitoring the adulteration of illicit compounds in dietary supplements.

Screening of illegal sexual enhancement supplements and counterfeit drugs sold in the online and offline markets between 2014 and 2017

The worldwide spread of illegal sexual enhancement products is posing a threat to public health. The aim of this study was to investigate illegal products claiming to be effective in improving sexual performance through the online or offline markets between 2014 and 2017; these products include foods, dietary supplements, counterfeit drugs, and herbal medicines. These samples were analysed by liquid chromatography-tandem mass spectrometry (LC–MS/MS) for the presence of 80 PDE-5 inhibitors (PDE-5i) and analogues. The developed method was validated as follows: LODs and LOQs spiked in solid- and liquid-type negative samples (0.03–3.33 ng/mL and 0.08–10.00 ng/mL), linearities (R2 > 0.997), recoveries spiked negative samples (82.2–109.3 %), accuracies (81.6–118.9 %), precisions (≥ 6.5%, RSD) of intra-day and inter-day, and stability (≥10.0%, RSD). Out of 362 measured samples, 145 were adulterated samples mostly detected in food (51%). Sildenafil group (50%) was frequently observed, followed by tadalafil group (41%). Although sildenafil and tadalafil were mainly detected in adulterated samples, their analogues were also found. In particular, new analogues have appeared steadily on illicit erectile dysfunction (ED) products even after they were first discovered. The concentration of detected samples ranged from 0.1 to 826.0 mg/g, and sildenafil of them contained a considerable amount in illicit ED products in 2014, posing a potential toxicology risk of public health. The testing method is fast and reliable making it suitable for both routine screening and up-to-date quantitative analysis of PDE-5i and their analogues in suspicious foods, dietary supplements, and counterfeit drugs.

Analysis of phosphodiesterase type 5 inhibitors as possible adulterants of botanical-based dietary supplements: extensive survey of preparations available at the Czech market

Popularity of natural-based preparations supporting the sexual potency significantly increased in recent years, which also led to the increase of illegal use of phosphodiesterase type 5 inhibitor (PDE-5) in sexual performance enhancement products. In this study, a rapid U-HPLC‒HRMS/MS method has been developed to simultaneously determine 59 PDE-5 inhibitors and their analogues.Within the development of sensitive method for analysis of 59 PDE-5 inhibitors and their analogues, both sample preparation procedure, as well as separation / detection conditions have been optimized. Extraction efficiency of particular extraction solvents, influence of different mobile phase additives on target analytes separation, as well as impact of various settings of mass analyzer on sensitivity of detection were examined. Data were collected in the ‘full MS/data dependent MS/MS’ acquisition mode (full MS–dd-MS/MS). Before the U-HPLC‒HRMS/MS method was used for analysis of real samples, proper validation had been conducted. The precision of the method expressed as the relative standard deviation (RSD) was ≤4.2% and ≤5.2% at spiking concentrations 5 μg/g and 0.25 μg/g, respectively. The limits of quantification were in the range 0.25 – 0.05 μg/g and the recovery ranged between 71 and 90%. The optimized method was successfully applied for analysis of 64 real samples, and 10 of them were proved to contain both registered or unregistered synthetic PDE-5 inhibitors. Additionally, the acquired U-HPLC‒HRMS/MS fingerprints were demonstrated to serve as an efficient tool for revealing of other type of possible fraud in products labeling. Retrospective mining of markers of herbs declared on dietary supplements packaging allowed to assess the trueness / untruth in the declaration of medical herbs composition.

Phosphodiesterase (PDE5) inhibition assay for rapid detection of erectile dysfunction drugs and analogs in sexual enhancement products.

Products marketed as dietary supplements for sexual enhancement are frequently adulterated with phosphodiesterase-5 (PDE5) inhibitors, which are erectile dysfunction drugs or their analogs that can cause adverse health effects. Due to widespread adulteration, a rapid screening assay was developed to detect PDE5 inhibitors in adulterated products. The assay employs fluorescence detection and is based on measuring inhibition of PDE5 activity, the pharmacological mechanism shared among the adulterants. Initially, the assay reaction scheme was established and characterized, followed by analysis of 9 representative PDE5 inhibitors (IC50 , 0.4-4.0ngmL-1 ), demonstrating sensitive detection in matrix-free solutions. Next, dietary supplements serving as matrix blanks (n = 25) were analyzed to determine matrix interference and establish a threshold value; there were no false positives. Finally, matrix blanks were spiked with 9 individual PDE5 inhibitors, along with several mixtures. All 9 adulterants were successfully detected (≤ 5 % false negative rate; n = 20) at a concentration of 1.00mgg-1 , which is over 5 times lower than concentrations commonly encountered in adulterated products. A major distinction of the PDE5 inhibition assay is the ability to detect adulterants without prior knowledge of their chemical structures, demonstrating a broad-based detection capability that can address a continuously evolving threat of new adulterants. The PDE5 inhibition assay can analyze over 40 samples simultaneously within 15minutes and involves a single incubation step and simple data analysis, all of which are advantageous for combating the widespread adulteration of sex-enhancement products.

Analysis of Safety Alerts Associated with Dietary Supplements from Japan and Overseas

The prevalence of dietary supplement use has increased in Japan, and consumers can purchase supplements from foreign countries through the internet. Therefore, it is important to consider both domestic and overseas safety alerts to prevent adverse events associated with dietary supplement use. We have been collecting global safety alerts associated with dietary supplements and providing this information to the public via the "Information system on safety and effectiveness for health foods (HFNet)" website. In this study, we analyzed the characteristics of safety alerts from 2010 to 2016 in HFNet (total: 2,124 alerts). The most common reason for alerts was illegal adulteration with pharmaceutical substances (85%), and sexual enhancement or weight loss products accounted for 68% of all alerts. Most alerts were based on market surveillance reports or recall information. However, 181 adverse event reports were identified, and most of them were related to weight loss or disease treatment in patients. In Japan, a majority of the adverse events was caused by products intended for weight loss or purchased online, and young female users were commonly involved. These findings should be helpful for prevention of adverse events associated with dietary supplement use.

A cross-sectional survey of sex toy use, characteristics of sex toy use hygiene behaviours, and vulvovaginal health outcomes in Canada

Researchers' interest in the use of sex toys has increased in the past 10 years as products become more accepted in mainstream media, and incorporated into individuals' sexual scripts. Though researchers and health educators have emphasized the importance of sex toy use hygiene behaviours, few studies have addressed the extent to which individuals are sharing, cleaning and covering their sex toys. The current research examined 1) the prevalence, frequency, predictors, and types of sex toys use/used, 2) the prevalence/frequency of sex toy use hygiene behaviours (e.g., cleaning, sharing, covering) and 3) whether sex toy use hygiene behaviours were related to vulvovaginal health outcomes among a sample of Canadian participants. As part of a larger survey examining genital health and hygiene practices, 1435 participants across Canada completed an anonymous online survey. Prevalence of sex toy use was 52.3%. Sex toys users were more likely to report a bisexual, lesbian, queer or questioning identity and were more likely to report engaging in additional partnered sexual activities such as oral and anal sex. Participants used a wide variety of sex toys including vibrators, butt plugs, BDSM toys, and household items. Most participants indicated that they cleaned their sex toys regularly using soap and water and 21.7% reported sharing their sex toy(s) with a partner. Sex toy use is common among Canadian women and individuals report using a variety of sexual enhancement products. Implications for educators and medical practitioners working with sexually active clients are also discussed.

Synthesis and Structure Revision of Dimeric Tadalafil Analogue Adulterants in Dietary Supplements

A number of phosphodiesterase 5 (PDE5) inhibitors approved by authorities have been used successfully in the treatment of erectile dysfunction. These medicines must be prescribed carefully due to their adverse effects, but they and their analogues are being illegally added to dietary supplements. These illegal dietary supplements pose a significant risk to public health. Several dimeric tadalafil analogues have been synthesized for use as reference standards in the inspection of functional foods that are mainly advertised as sexual enhancement products. During the course of this synthesis, 1-[bis(dimethylamino)methylene]-1H-1,2,3-triazolo[4,5-b]pyridinium 3-oxid hexafluorophosphate (HATU) was proven to be the reagent of choice for amide coupling to produce these dimeric tadalafil analogues. Moreover, the trans-isomer structures tentatively assigned for the isolated dimeric tadalafil analogues (bisprehomotadalafil and bisprecyclopentyltadalafil) found in dietary supplements are now revised to cis-isomer structures.

The public purchase of aphrodisiac products without prescriptions in the Alahsa region of KSA

Abstract Objectives To investigate requests for common prescription-only aphrodisiacs across community pharmacies in the Alahsa region of KSA. Methods A cross-sectional study was conducted among conveniently selected pharmacies in the eastern region of Alahsa, KSA. Self-administered questionnaires were directly distributed to 73 consenting community pharmacies. Completed questionnaires were coded, reviewed for accuracy and entered into a database in Statistical Package for the Social Sciences (Version 19.0; IBM Corporation, Somers, NY). The data were analysed using descriptive analysis. Results The survey response rate was 72.60%. With respect to the availability of aphrodisiacs and sexual supplements, most of the pharmacists disclosed that they had stocks of Viagra and Cialis. The most common men's health complication reported by pharmacists was erectile dysfunction (n = 12, 22.6%), followed by premature ejaculation (n = 4, 7.5%) and low sexual desire (n = 1, 1.9%). Less than half of pharmacists (n = 9, 16.9%) cited Viagra and Cialis as preferred drugs for treating premature ejaculation. Approximately 32 (60.3%) proposed delayed sprays as the first line of action, while 13 (24.5%) considered antidepressants as their first-choice drug. Conclusion The non-prescription dispensing of prescription-only medicines, including sexual enhancement products, is common in KSA. The majority of pharmacists continue to violate pharmaceutical laws without recognizing the potential harm they are causing their communities. Stakeholders should organize training and certification initiatives to ensure that pharmacists are aware of and comply with national pharmaceutical laws. These agencies should also ensure that pharmacies maintain safe and ethical practices.

Safety and Quality Concerns Regarding Over-the-Counter Sexual Enhancement Products Sold in the USA Market Pose a Major Health Risk.

Safety and quality concerns regarding over the counter sexual enhancement products sold in the USA market pose a major health risk to the general public. Nevertheless, the use of herbal medicines continues to expand rapidly across world and many people perceive usage of herbal medication as a safe and reliable way to improve health outcome. The safety of herbal supplements has become a globally major concern in national and international health authorities due to increasing adverse events and adulterations associated with usage of herbal medications. These non FDA approved products with unknown ingredients are widely accessible for purchase ranging from local food, drug stores and to the internet.These Erectile Dysfunction (ED) pills may contain Sildenafil, the active ingredient of Viagra in much higher quantity then legally prescribed by a licensed physician or they may contain unknown quantities of Thiosildenafil, the active ingredient in Cialis. The types of chemicals found in these medications are making it harder for regulatory authorities to track them down. These products keep the consumer in the dark in terms of the quantity, ingredients, effectiveness and possible side effects. These sexual enhancement products are being sold as safe and natural with false hopes to resolve erectile dysfunction. Patients who are prone to impulsive hypersexual behavior such as patients with bipolar disorder, substance use, borderline personality disorder and those who may feel adamant to discuss erectile dysfunction with their physicians are more likely to become the victims of using illicit medications/ drugs with serious health risks consequences.We present a case report of an individual with bipolar disorder and hypersexual behavior who became victim to over the counter sexual enhancement products/supplements which caused serious health and life threatening consequences.

Pornography, Sexual Enhancement Products, and Sexual Risk of Female Sex Workers and their Clients in Southern India

Despite their large numbers, and important role in the HIV epidemic in India, male clients of female sex workers (FSWs) are a difficult to reach population and little is known about their sexual behaviors. Using data from an integrated behavioral and biological assessment of 684 clients in Bangalore in 2012, we examined factors associated with their reports of having sex with three or more different female sex workers in the last month, and anal sex with sex workers. We included sociodemographic and sexual behavior factors and, for the first time in client studies in India, included data on the use of pornography and sexual enhancement products (SEPs) such as pills, oils, and sprays, in our multivariable analyses of client risk. Seventy-eight percent of clients had seen pornographic material and 8% reported ever having used SEPs. The profiles of men practicing the two risk behaviors examined were quite different. Travel in the past year, drunkenness in the past month, young age at first commercial sex, non-use of condoms at last sex, and finding sex workers in public places (but not use of pornography and SEPs) were independently associated with multiple partnering. Sex with a man or transsexual, being a white collar worker, seeking out FSWs at home, pornography and SEP use, and condom use at last FSW sex, were all independently associated with anal sex with an FSW. More research is needed to better understand the links between pornography and SEPs, and HIV risk behaviors, and HIV prevention programs need to be cognizant of the importance of ensuring that condom use is adequately promoted and supported in the context of anal sex in female sex worker-client interactions.

Vibrators and other sex toys are commonly recommended to patients, but does size matter? Dimensions of commonly sold products.

Vibrators and dildos are commonly used by women and men in the United States, and are increasingly recommended by clinicians. In addition, sex toys and various household objects are sometimes used for sexual stimulation in ways that pose health risks to their users. Data about the dimensions of such products may inform clinicians' recommendations. The purpose of the present study was to assess the sizes (length and circumference) of vibrators and dildos marketed for vaginal or anal insertion on websites that sell sexual enhancement products. Eight websites that sell sexual enhancement products were identified for inclusion in the study. The dimensions of vaginal vibrators and dildos listed for sale on each website were noted, and descriptive data were calculated for each website. Product length and circumference (mean, median, and range). Popular sex toy distributers offer a variety of product sizes. The length of many vibrators and dildos was sized between 4 and 6 in, and circumference was between 4 and 5 in. However, some companies featured products of a considerably larger size than others. Length and circumference of vibrators and dildos varied, but on average approximated mean penile dimensions. Clinicians' recommendations for use of vaginal or anal products can be enhanced by familiarity and offering additional information about product sizes and retailers.

Magic Power: changing gender dynamics and sex-enhancement practices among youths in Makassar, Indonesia

This paper examines changing sexualities and gender relations as they are reflected in the use of sexual enhancement products by young women and men in the eastern Indonesian city of Makassar. To examine the relationships between the use of these products and socially sanctioned gender roles, their ‘gender scripts’ were studied – the assumptions embedded in the products’ design and advertising. What kinds of femininity and masculinity are expressed through their use? It was found that the most popular products – ‘magic tissues’ that promise to prolong erections and a ‘neotraditional’ vaginal wash that promises to cleanse, perfume, and tighten vaginas – espouse the dual purpose of promoting sexual pleasure and hygiene. While it was found that the images in advertising to reflect changing gender relations in the field site, this research also points to enduring gender scripts in Indonesian culture: men should be virile, women should be clean and attractive.

Sexual enhancement products for sale online: raising awareness of the psychoactive effects of yohimbine, maca, horny goat weed, and Ginkgo biloba.

Introduction. The use of unlicensed food and herbal supplements to enhance sexual functions is drastically increasing. This phenomenon, combined with the availability of these products over the Internet, represents a challenge from a clinical and a public health perspective. Methods. A comprehensive multilingual assessment of websites, drug fora, and other online resources was carried out between February and July 2013 with exploratory qualitative searches including 203 websites. Additional searches were conducted using the Global Public Health Intelligence Network (GPHIN). Once the active constitutes of the products were identified, a comprehensive literature search was carried out using PsycInfo and PubMed. Results. The most common sexual enhancement products available on the Internet were identified. Their active ingredients included yohimbine, maca, horny goat weed and Ginkgo biloba. These four substances were reported with the occurrence of adverse events and the induction of psychological symptoms, such as mood changes, anxiety, and hallucinations as well as addictive behaviours. Conclusions. Uncontrolled availability of sexual enhancement products that contain potentially harmful substances is a major public health concern. The possible impact on population health, particularly among subjects with psychiatric disorders, usually at risk for sexual dysfunction, may be significant. This new trend needs to be extensively studied and monitored.

Table of Contents

AbstractGenetic variants matter for folate response in schizophreniaMothers' choline use could mitigate schizophrenia riskComparison of QT prolongation among iloperidone, quetiapine, and ziprasidoneUse of folic acid near conception can lower autism riskImpact of switching atypicals on heart disease and metabolic syndromeCNR1 gene and risk of the metabolic syndromeLow‐dose ketamine for major depressionAntidepressant treatment of bipolar depressionNaltrexone efficacy may decrease over timeAntidepressants for depression in Parkinson's diseaseTainted sexual enhancement products

Adverse events associated with the use of complementary medicine and health supplements: An analysis of reports in the Singapore Pharmacovigilance database from 1998 to 2009

Context. The use of complementary and alternative medicine (CAM), particularly herbal medicine and their derived products, have been increasing. However, sporadic reports of serious adverse effects associated with the use of these products have become a source of concern. Spontaneous adverse event reporting may be used to monitor the safety of these products. Objective. The objectives of this study is to analyze and describe the patterns of adverse events associated with the use of Chinese Proprietary Medicine, other complementary medicine and health supplements (termed CAM products) in the Singapore Pharmacovigilance database from 1998 to 2009 and to highlight areas of safety concerns. Methods. Adverse events associated with CAM products reviewed by the Vigilance Branch of the Health Sciences Authority for the period 1998–2009 were collated and analyzed. The following information was extracted and collated: patient demographics, type and indication of CAM products, system-organ class affected, seriousness of the adverse event, route of administration, hospitalization status, outcome of adverse event, concomitant use of conventional medicine, adulterant testing and profession of the reporter. Results. In the period 1998–2009, 627 cases of adverse events due to CAM products were reported. Most of these 627 cases (80.2%) were found to be serious and most of the patients used CAM products for sexual performance enhancement (291, 46.4%), to relieve pain such as joint and neck pain (36, 5.9%) and for slimming purposes (27, 4.3%). Of the 627 cases, endocrine disorders constituted 22.5% and central nervous system disorders constituted 20.6%. Liver was the main organ involved in the serious cases. Twenty-two fatalities were reported and hepatotoxicity was responsible for the deaths of 10 patients during the study period. Conclusions. In conclusion, 627 adverse event reports associated with CAM products had been successfully analyzed and described. They constituted ∼3.8% of the total number of adverse events reported from 1998 to 2009. Outbreaks of severe hypoglycemia in 2008 and 2009 were associated with the use of adulterated and illegal sexual performance enhancement products. Further work to confirm the hepatotoxicity of implicated CAM products is warranted. Reporting of suspected adverse events is strongly encouraged even if the causality is not confirmed because any signs of clustering will allow rapid regulatory actions to be taken. The analysis of spontaneously reported adverse events is important in monitoring the safety of CAM products and helps in the understanding of the benefits and risks associated with the use of such products.

Sex Toy Use by Gay and Bisexual Men in the United States

Recent studies have documented that vibrators are an important part of the sexual repertoires of both men and women and have demonstrated positive sexual health outcomes among individuals who use such products. However, little is known about the use of other sexual enhancement products, particularly among gay and bisexually identified men. This study sought to document the extent to which gay and bisexually identified men report using sex toys and the sexual and relational situations within which they used them. Data were collected via an internet-based survey from 25,294 gay and bisexually identified men throughout the U.S. recruited from an Internet site popular among men seeking social or sexual interactions with other men. A majority (78.5%) of gay and bisexually identified men reported having used at least one type of sex toy, including dildos (62.1%), non-vibrating cock rings (51.9%), vibrators (49.6%), butt plugs (34.0%), masturbation sleeves (27.9%), and anal beads or balls (19.3%). Among users, toys such as dildos or butt plugs were commonly inserted into one's own anus during masturbation (95.7%, n = 11,781) and insertion into their partners anus (72.0% n = 4,197) during partnered sexual activities. These data suggest that sex toy use is common among gay and bisexual men during both solo and partnered sexual activities and considered by these men as enhancing the quality of their sexual experiences.