WASHINGTON—FDA issued a warning for another set of sexual dysfunction products marketed as dietary supplements but found to contain undeclared compounds common to erectile dysfunction (ED) drugs. The agency advised the public not purchase or use Hero or Blue Steel brand products, which pose a danger to a person's blood pressure.
These products are sold online as “all-natural” dietary supplements; however, they contain undeclared and unapproved substances similar in chemical structure to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for ED. FDA clarified its chemical analysis revealed both Hero and Blue Steel contain substances that are similar in chemical structure to sildenafil; however, they are not components of an FDA approved drug. Additionally, the products’ labels do not list any of these substances, making them unapproved drugs.
"Because these products are labeled as ‘all natural dietary supplements,’ consumers may assume that they are harmless and pose no health risk,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research. “But an unsuspecting consumer with underlying medical issues may take these products without knowing that they can cause serious side effects and interact in dangerous ways with drugs that a consumer is already taking."
The warning is especially important to consumers with diabetes, high blood pressure, high cholesterol or heart disease, who often take nitrates and commonly suffer ED as a side effect of these medical conditions. The concern is the undeclared ingredients in Blue Steel and Hero may interact with nitrates found in some prescription drugs (such as nitroglycerin), and can lower blood pressure to dangerous levels.
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