title: Pharmacovigilance on sexual enhancing herbal supplements.
abstract: The use of herbal medicines continues to expand rapidly across world and many people show positive interest to use herbal products for their health. The safety of herbal supplements has become a globally major concern in national and international health authorities due to increasing adverse events and adulterations. It is difficult to analyze herbal products that cause adverse events due to lack of sufficient information and expertise. Inadequate regulatory measures, weak quality control system and uncontrolled distribution channels are some of reasons that enhance the informal pharmaceutical market. In recent years, the unfulfilled desire for sex has been a subject that has aroused increasing public interest with respect to improve sexual functions. The use of herbal medicines substantially increased due to escalated prevalence and impact of sexual problems worldwide and estimates predicting the incidence to raise over 320 million by year 2025. The various reasons to use herbal supplements in men may be due to experiencing changes in erectile dysfunction (ED) due to certain medical conditions such as diabetes and hypertension and bodily changes as a normal part of life and aging. There is a lack of adequate evidence, no impetus to evaluate and absence of any regulatory obligations to undertake rigorous testing for safety and efficacy of herbal supplements before they sold over-the-counter (OTC). Pharmacovigilance on herbal supplements is still not well established. Sexual enhancing herbals are on demand in men health but informal adulteration is growing issue of concern. Recently, increase in use of herbal supplements for erectile dysfunction has laid a path for many illegal compositions. This paper explores facts and evidences that were observed in different countries attempting to demonstrate the importance of strengthening regulatory system to strengthen the application of pharmacovigilance principles on sexual enhancing supplements. We hereby explore the problem of sexual herbal supplements from pharmacovigilance perspectives. We provide insights into the various concerns and call for collaboration to resolve the problem. We highly recommend to include herbal medicines in national pharmacovigilance systems and to establish comprehensive national pharmacovigilance program to raise the awareness about herbal medicines particularly those used in enhancing sexual desire.
authors.affiliation: Department of Clinical Pharmacy, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.
authors.forename: Akshaya Srikanth
authors.initials: AS
authors.lastname: Bhagavathula
authors.affiliation: Pharmacology Department, College of Medicine and Health Sciences (CMHS)-United Arab Emirates University (UAEU), United Arab Emirates.
authors.forename: Asim Ahmed
authors.initials: AA
authors.lastname: Elnour
authors.affiliation: Internal Medicine Department, CMHS-UAEU, United Arab Emirates.
authors.forename: Abdulla
authors.initials: A
authors.lastname: Shehab