The Food and Drug Administration issued a health advisory Thursday warning consumers not to purchase or use three “male enhancement” products being sold online that contain hidden drug ingredients that could be dangerous.
Although makers of the three products say they are herbal remedies, FDA investigators say laboratory analyses have found that contain sildenafil, the active ingredient in the FDA-approved prescription drug Viagra, and/or similar medications used to treat erectile dysfunction.
“This undeclared ingredient [sildenafil] may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels,” the FDA said, in a posting on the agency’s website. “Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.”
Regulators said the agency has identified “an emerging trend” of over-the-counter products, frequently represented as dietary supplements and sold online, that contain hidden active ingredients that could be harmful.
“Consumers may unknowingly take products laced with varying quantities of approved prescription drug ingredients, controlled substances, and untested and unstudied pharmaceutically active ingredients,” the FDA said. “These deceptive products can harm you! Hidden ingredients are increasingly becoming a problem in products promoted for sexual enhancement.”
The three products sited by the FDA in the new advisory are “Stiff Days,” sold online and in some retail stores; “Libido Sexual Enhancer,” which was found to contain sildenafil and three other undeclared similar ingredients; and “Rock-it Man,” which is made with a sildenafil-like drug.
“This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals,” the FDA said.
“These products are typically promoted for sexual enhancement, weight loss, and body building, and are often represented as being ‘all natural.’ FDA is unable to test and identify all products marketed as dietary supplements on the market that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.”
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