ST LOUIS (MD Consult) - On November 19, 2010, the US Food and Drug Administration (FDA) issued a warning, cautioning consumers not to use or purchase Vigor-25, a product marketed as a natural dietary supplement to enhance male sexual performance. The FDA is investigating the reported death of a 26-year-old man, possibly associated with the use of Vigor-25.
According to the FDA, the product contains sildenafil, the active ingredient in the prescription drug Viagra. If sildenafil is used with nitrate drugs, dangerous drops in blood pressure can occur.
Vigor-25 is distributed by Piston Corp and is sold on Internet sites and possibly in some retail outlets. The FDA has found many products marketed as dietary supplements for sexual enhancement during the past several years that can be harmful because they contain active ingredients in FDA-approved drugs or variations of these ingredients. Sexual enhancement products promising to provide rapid or long-lasting effects are likely to contain a contaminant.
In the event of any adverse effects associated with consumption of these products, consumers are instructed to contact a physician immediately. Adverse events that may be related to the use of these products should be reported to the FDA's Med Watch Program.
圣路易斯(MD Consult)——2010年11月19日，美国食品药品管理局(FDA)发布一则警告，提醒消费者切勿使用或购买活力-25(Vigor-25)，该产品是一种市售的天然膳食补充剂，可增强男性的性功能。FDA正在对一名26岁男性的死亡报告进行调查，初步判断其死因可能与使用活力-25有关。
据FDA称，该产品含有处方药伟哥的有效成分西地那非。若西地那非与硝酸盐类药物联用，服用者的血压可能出现危险性的下降。
活力-25由活塞公司(Piston Corp)分销，并通过网站销售，还可能在某些零售药店出售。FDA发现，在过去几年中以增强性功能的膳食补充剂形式上市的许多产品都可能会有害，因为它们含有FDA批准药物中的有效成分或这些成分的变异形式。承诺起效迅速或作用持久的性功能增强产品都可能含有某一种杂质。
FDA建议消费者，若发生与使用这些产品有关的任何不良反应，则立即联系医生，同时还应将可能与使用这些产品相关的不良事件上报至FDA的Med Watch Program。
