FDA Warns Sex Products Contain Undeclared Drugs

WASHINGTONOnce again, FDA issued a warning about dangerous sexual performance products marketed as dietary supplements and originating from China that contain undeclared drug ingredients. The agency warned 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. The products are marketed for the treatment of erectile dysfunction (ED) and for sexual enhancement, but they contain undeclared active ingredients of FDA-approved prescription ED drugs and are, thus, illegal without FDA approval.

FDA testing revealed Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, and Lady Shangai contain sildenafil, the active ingredient in Viagra, while 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. The agency reported neither sildenafil nor the analog of sildenafil is listed as an ingredient on the label of any of these products.

FDA warned the undeclared ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. The agency noted consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates. It added ED is a common problem in men with these medical conditions, who may seek natural products because they have been advised against taking ED drugs. Additionally, FDA advised the safety, efficacy, and purity of these ingredients can not be validated because the manufacturing source of the active ingredients in these products is unknown.

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.

Consumers who have purchased or used any of these Shanghai products are urged to discontinue use and seek medical attention from their health care provider, if any adverse events occur. Consumers and health care professionals can report adverse events to FDA's MedWatch program at 800-FDA-1088 or online at FDA.gov/medwatch/report.htm.