多种性功能增强产品被FDA叫停

圣路易斯(MD Consult)——2013年6月27日，美国食品药品管理局(FDA)发出了有关互联网及某些零售店出售的5种性功能增强产品的安全性警示。这些产品分别名为“Clalis”、“Exten 1300”、“MVP Mega”、“MaxTreme Zen”及“Silver Sword”。所有这些产品均含有未申报的成分，使用后可能会对患有某些疾病的男性造成危险，因为这些成分可能与某些处方药中的硝酸盐发生相互作用，可能使血压降至危险水平。

FDA已经对上述产品进行了分析，发现它们含有西地那非和(或)他达拉非。西地那非和他达拉非是FDA批准用于治疗勃起功能障碍的处方药物中的有效成分。

对于与使用上述产品有关的不良事件，应上报至FDA的MedWatch不良事件报告系统。

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ST LOUIS (MD Consult) - On June 27 and June 28, 2013, the US Food and Drug Administration (FDA) issued safety alerts concerning 5 products promoted for sexual enhancement that are sold via the Internet and in some retail stores. These products are known as Clalis, Exten 1300, MVP Mega, MaxTreme Zen, and Silver Sword. All of these products contain undeclared ingredients, and their use may pose a risk to men with certain health problems. These ingredients may interact with nitrates found in some prescription drugs (eg, nitroglycerin) and may lower blood pressure to dangerous levels.

The FDA has analyzed all of these products, and found that they contain either sildenafil or tadalafil (or both). Sildenafil and tadalafil are the active ingredients in FDA-approved prescription drugs used in the treatment of erectile dysfunction.

Adverse events related to use of these products should be reported to the FDA's MedWatch Adverse Event Reporting Program.