Some Chinese products marketed as dietary supplements could reduce blood pressure to dangerous levels if used to treat erectile dysfunction,† the US Food and Drugs Administration (FDA)†says.
The products, produced in China, are marketed for the treatment of erectile dysfunction and for sexual enhancement. Although they're marketed as dietary supplements, they don't qualify as supplements because they contain "undeclared" active ingredients of FDA-approved prescription drugs for erectile dysfunction, like sildenafil, used in the making of the blockbuster drug Viagra.† That makes the products illegal because they lack FDA approval, the agency said in a statement released Friday evening.
The products are marketed as Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, Shangai Regular and Shangai Chaojimengnan products, the FDA said.
The agency said it performed chemical testing that showed 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 impotence. Shangai Regular, also marketed as Shangai Chaojimengnan, contains an unapproved substance with a chemical structure akin to sildenafil that may cause similar side effects and drug interactions.
These undeclared ingredients could interact with nitrates found in some prescription drugs -- such as nitroglycerin -- and can lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Erectile dysfunction is a common problem in men with these medical conditions.
"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 Dr. Janet Woodcock, the agency's deputy commissioner for scientific and medical programs, and acting director of the Center for Drug Evaluation and Research. "An unsuspecting consumer with underlying medical issues may buy and take these products without knowing that they can cause serious drug interactions."