Pharmacies and other retailers are being urged to discontinue sales of several OTC preparations marketed as dietary supplements for sexual enhancement and treatments for erectile dysfunction (ED).
The supplements, sold nationwide under the names "True Man" and "Energy Max," contain analogs of sildenafil and/or vardenafil - key ingredients in legitimate sexual enhancement drugs such as sildenafil citrate (Viagra) and vardenafil HCl (Levitra). Significantly, the agency is taking action against the supplements, not because they are ineffective, but because they may work too well.
"These products threaten the health of the people using them because they contain undeclared chemicals that are similar to the active ingredients used in FDA-approved prescription drug products," said Steven Galson, MD, MPH, director of the FDA's Center for Drug Evaluation and Research. "The risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure."
According to the FDA, the undeclared ingredients in True Man and Energy Max may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. "Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates," said the FDA.
None of those warnings appeared on product labels or in ads for the supplements. Instead, the supplier made performance claims that go beyond those for Viagra and other ED products.