美国食品和药物管理局星期一在网站上警告说，中国生产的含有“伟哥”成分的营养补充品可能给消费者带来伤害。

美国食品和药物管理局提醒消费者不要购买“Super Shangai、Strong Testis、Shangai Ultra、Shangai Ultra X、Lady Shangai、Shangai Regular、也叫做Shangai超级猛男的产品”。

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美国食品和药物管理局的声明说，这些原产于中国的营养补充品中都没有在标签上注明含有“伟哥”的活性成分西地那非或类似成分。

声明说，这些产品中没有公布的成分可能会和一些处方药里的成分发生作用，使得血压降低到危险的程度，特别会给糖尿病、高血压、高血脂和心脏病患者带了风险。这些疾病是性功能障碍患者的常见病，医生可能会告诫他们不要服用那些有改善性功能的药物，因此他们会寻求全自然产品或不含处方药成分的产品。

FDA News FOR IMMEDIATE RELEASE
December 28, 2007
Media Inquiries:
301-827-6242
Consumer Inquiries: 888-INFO-FDA

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01766.html

FDA Warns Consumers Not to Use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular (also known as Shangai Chaojimengnan)
These products are illegal drugs and contain undeclared active ingredients in pre????ion erectile dysfunction drugs

The U.S. Food and Drug Administration (FDA) is advising consumers not to buy or use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular, also marketed as Shangai Chaojimengnan, products.

These products, which originate in China, are being marketed for the treatment of erectile dysfunction (ED) and for sexual enhancement. Although labeled as dietary supplements, these products do not qualify as dietary supplements because they contain undeclared active ingredients of FDA-approved pre????ion drugs for erectile dysfunction. The products are thus drugs that are illegal because they lack FDA approval.

The undeclared ingredients in these products may interact with nitrates found in some pre????ion drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these medical conditions. Because they may have been advised against taking ED drugs, they may seek out products like these because they are marketed as "all natural" or as not containing the active ingredients in approved, prescribed ED drugs. Additionally, because the manufacturing source of the active ingredients in these products is unknown, consumers should be aware that the safety, efficacy, and purity of these ingredients can not be validated.

"Products like these put consumers at considerable risk because they contain undeclared active ingredients in FDA approved drugs that require a pre????ion to obtain," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug ????uation and Research (CDER). "An unsuspecting consumer with underlying medical issues may buy and take these products without knowing that they can cause serious drug interactions."

FDA performed chemical testing of the products that revealed that Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, and Lady Shangai contain sildenafil, the active ingredient in Viagra, an FDA-approved drug for erectile dysfunction. Shangai Regular, also marketed as Shangai Chaojimengnan, contains an unapproved substance with a structure similar to sildenafil that may cause similar side effects and drug interactions. Neither sildenafil nor the analog of sildenafil is listed as an ingredient on the label of any of these products.

FDA advises consumers who have used any of these products to discontinue use and consult their health care providers if they have experienced any adverse events that they feel are related to the use of these products. Consumers and health care professionals can report adverse events to FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm. FDA recommends that consumers should talk to their health care provider about FDA-approved treatments for erectile dysfunction. FDA may take further regulatory actions to protect consumers from these illegal products.

The products are packaged and distributed by Shangai Distributor, Inc. of Coamo, Puerto Rico.