ST LOUIS (MD Consult) - On June 19, 2010, the US Food and Drug Administration (FDA) issued a notice warning consumers to avoid using a product known as Magic Power Coffee. The product is an instant coffee and is marketed as a dietary supplement for the promotion of sexual enhancement.
An FDA analysis of Magic Power Coffee revealed the presence of hydroxythiohomosildenafil, a chemical similar to sildenafil and the active ingredient in Viagra. The agency states that this component of the product is considered an undeclared drug ingredient. The label describes the product as an "all natural dietary supplement."
When taken by persons who also take nitrate medications, hydroxythiohomosildenafil, like sildenafil, may lead to dangerous drops in blood pressure. Sexual enhancement products that claim to work as well as prescription products are likely to expose consumers to unpredictable risks and the potential for injury or even death, according to the FDA.
Magic Power Coffee is distributed on Internet sites and online auctions by multiple independent distributors participating in an online multilevel marketing scheme. It is sold in a 2-serving box and a 12-serving carton containing six 2-serving boxes.
The FDA is advising consumers who have experienced any negative adverse effects from sexual enhancement products to consult a health care professional and to safely discard the product. Adverse events may be reported to the FDA's MedWatch program.
圣路易斯(MD Consult)——2010年6月19日,美国食品药品管理局(FDA)发布了一则通知,警告消费者切勿摄入名为“魔力咖啡”的饮品。该产品是一种速溶咖啡,以增强性功能的膳食补充剂形式销售。
FDA对魔力咖啡所做的一项分析显示,该产品中存在羟基硫基好猫西地那非(hydroxythiohomosildenafil),这种化学物质类似于西地那非,即伟哥中的有效成分。FDA声明,这种成分被视为未申报的药品成分。产品说明书将该产品描述为“纯天然的膳食补充剂”。
服用硝酸盐类药物的患者同时服用羟基硫基好猫西地那非,类似于服用西地那非,也可能会导致血压危险性下降。据FDA称,声称与处方药同等有效的增强性功能产品可能会使消费者有不可预知的风险,还可能会招致损伤甚至是死亡。
魔力咖啡由加入网上多层次销售网络的多个独立分销商通过网站或网上拍卖分销。其市售形式为2袋装的小盒及12袋装的大盒(内含6个2袋装小盒)。
对于因摄入增强性功能产品而发生任何不良反应的消费者,FDA建议其咨询医护专业人员并安全地处置产品,同时亦可将不良事件上报至FDA的MedWatch系统。