"This incident is an example of a growing trend of products marketed as dietary supplements or conventional foods with hidden drugs and chemicals," said Ilisa Bernstein, the agency’s deputy director of the Office of Compliance, Center for Drug Evaluation and Research.
"These types of products are typically promoted for sexual enhancement, weight loss, and body-building, and are often represented as being 'all natural.' Consumers should exercise caution before purchasing products promoted for these uses."
Bernstein’s comments came after the FDA warned consumers to distinguish between the legitimate ExtenZe and a counterfeit look-alike product.
FDA laboratory analysis confirmed the counterfeit contained undisclosed tadalafil, or a combination of tadalafil and sildenafil. Both are active ingredients in FDA-approved prescription drugs for erectile dysfunction.
But both could interact with other medicines, such as the nitrates found in some prescription medicines such like nitroglycerin, and may lower blood pressure to dangerous levels, warned the agency.
“Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates and would be especially susceptible to contraindication with tadalafil or sildenafil,” according to a FDA statement.
The counterfeit ExteZe is illegal and unsafe and consumers should avoid any product bearing this brand name and lot number 1110075 or F050899.
Consumers who have bought an ExtenZe product check for these lot numbers on the package. They should stop taking the supplements associated with these lot numbers and report any adverse health effects to their health care professional.
All natural herbs
ExtenZe’s promotional website claims that the supplement is a medically-formulated “mix of all natural herbs,” including herbal extracts rich in a chemical called tribistol, which promotes blood flow within the pelvic circulatory system.
Meanwhile, in March the FDA issued a statement warning consumers to “beware of fraudulent dietary supplements.”
The agency reported the identification of nearly 300 “fraudulent products” during its crackdown on illegal products.
The fraudulent products, usually targeted at the sexual enhancement, weight loss, bodybuilding sectors, contained FDA-approved drugs or their analogs or non-approved compounds such as synthetic steroids.