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 prescription 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 prescription 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 prescription 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 Evaluation 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.

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