Pfizer Inc., New York, NY 10017, USA.
J Sex Med. 2013 Jul;10(7):1842-9. doi: 10.1111/jsm.12172. Epub 2013 May 1.
Many products labeled "herbal" or "all natural" (herbal/natural) that claim to enhance sexual performance and imply use for the treatment of erectile dysfunction (ED) are marketed as over-the-counter (OTC) dietary supplements. However, adulteration with undeclared phosphodiesterase type 5 (PDE5) inhibitors appears widespread.
To assess the availability, cost, origin, categorical content, and adulteration with PDE5 inhibitors of purported herbal/natural OTC dietary supplements claiming to naturally enhance sexual performance.
Pfizer Global Security coordinated sample collection (all from convenience stores and filling stations in two U.S. metropolitan areas except for seven from U.S. Customs seizures) and liquid chromatography/mass spectrometry examination.
Adulteration with synthetic PDE5 inhibitors.
Ninety-one samples labeled as 58 distinct products and priced from $2.99 to $17.99 were evaluated. Origin/manufacture was claimed as United States (n = 62), apparently Asian (n = 15), and not clearly identified (n = 14). Although no sample claimed to include synthetic substances, 74 (81%) contained PDE5-inhibitor pharmaceutical ingredients, including tadalafil and/or sildenafil (n = 40, of which 18 contained >110% of the highest approved drug product strength) or PDE5-inhibitor analogs (n = 34). Pronounced heterogeneity of contents between samples within individual products indicated minimal quality control during manufacture. Labeling was inadequate (e.g., lacking lot number and/or expiry date) for 17 products (23 samples) and inconsistent between samples within a given product (e.g., in manufacturer, lot number, and/or expiry date) for seven of 17 products having multiple samples. Only 14 samples warned against concomitant nitrate use.
Ethical pharmaceutical companies are concerned for an unsuspecting public when their products are counterfeited, mislabeled, and illegally offered for sale in an unsafe manner. Because of the dangers of adulteration with synthetic PDE5 inhibitors, absent safety warnings, and lack of quality or consistent manufacture, men with ED unknowingly risk their health by using OTC herbal/natural products that claim to enhance sexual performance.
许多标有“草本”或“纯天然”（草本/天然）字样、声称能提高性表现并暗示可用于治疗勃起功能障碍（ED）的产品，都作为非处方（OTC）膳食补充剂销售。然而，这些产品中添加未申报的磷酸二酯酶 5（PDE5）抑制剂的情况似乎很普遍。
评估声称能自然增强性表现的草本/天然 OTC 膳食补充剂的供应情况、价格、来源、类别内容和 PDE5 抑制剂的掺假情况。
辉瑞全球安全协调样本采集（均来自美国两个大都市区的便利店和加油站，除了 7 个来自美国海关缉获）和液相色谱/质谱检测。
合成 PDE5 抑制剂的掺假情况。
评估了 91 个标有 58 种不同产品的样本，价格从 2.99 美元到 17.99 美元不等。声称的原产国/制造国为美国（n=62）、亚洲（n=15）和来源不明（n=14）。尽管没有样本声称包含合成物质，但 74 个（81%）样本含有 PDE5 抑制剂药物成分，包括他达拉非和/或西地那非（n=40，其中 18 个含有超过最高批准药物产品强度的 110%）或 PDE5 抑制剂类似物（n=34）。同一产品内不同样本的内容物存在明显的异质性，表明制造过程中质量控制不足。17 个产品中有 17 个产品（23 个样本）的标签不充分（例如缺乏批号和/或有效期），且在给定产品内的不同样本之间标签不一致（例如制造商、批号和/或有效期）。只有 14 个样本警告不要同时使用硝酸盐。
当他们的产品被伪造、贴错标签和以不安全的方式非法销售时，有道德的制药公司会为不知情的公众感到担忧。由于添加合成 PDE5 抑制剂、缺乏安全警告以及缺乏质量或一致的制造的危险，ED 男性在不知情的情况下使用声称能提高性表现的 OTC 草本/天然产品，从而使他们的健康面临风险。
