Bhagavathula Akshaya Srikanth, Elnour Asim Ahmed, Shehab Abdulla
Department of Clinical Pharmacy, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.
Pharmacology Department, College of Medicine and Health Sciences (CMHS)-United Arab Emirates University (UAEU), United Arab Emirates.
Saudi Pharm J. 2016 Jan;24(1):115-8. doi: 10.1016/j.jsps.2015.01.018. Epub 2015 Feb 7.
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.
草药的使用在全球范围内持续迅速增长,许多人对使用草药产品促进健康表现出积极兴趣。由于不良事件和掺假行为不断增加,草药补充剂的安全性已成为国家和国际卫生当局全球主要关注的问题。由于缺乏足够的信息和专业知识,很难分析导致不良事件的草药产品。监管措施不足、质量控制体系薄弱和分销渠道不受控制是促进非正规药品市场的一些原因。近年来,对性的未满足欲望一直是一个引起公众对改善性功能日益关注的话题。由于全球范围内性功能问题的患病率和影响不断上升,预计到2025年发病率将超过3.2亿,草药的使用大幅增加。男性使用草药补充剂的各种原因可能是由于某些疾病(如糖尿病和高血压)导致勃起功能障碍(ED)发生变化,以及身体变化是生活和衰老的正常组成部分。在草药补充剂作为非处方药销售之前,缺乏足够的证据、没有评估的动力且没有任何监管义务对其安全性和有效性进行严格测试。草药补充剂的药物警戒仍未得到很好的确立。增强性功能的草药在男性健康领域有需求,但非正规掺假是一个日益令人担忧的问题。最近,用于治疗勃起功能障碍的草药补充剂使用增加为许多非法成分铺平了道路。本文探讨了在不同国家观察到的事实和证据,试图证明加强监管体系以强化药物警戒原则在增强性功能补充剂上应用的重要性。我们在此从药物警戒角度探讨性草药补充剂问题。我们深入了解各种问题,并呼吁合作解决该问题。我们强烈建议将草药纳入国家药物警戒系统,并建立全面的国家药物警戒计划,以提高对草药尤其是用于增强性欲的草药的认识。