FDA Warns on Counterfeit Sex Supplement

WASHINGTONFDA warned consumers about a counterfeit product represented as the male sexual enhancement supplement ExtenZe, noting the counterfeit product looks similar to the actual product, but contains undisclosed drug ingredients that can cause serious harm to consumers.

FDA conducted a laboratory analysis on the counterfeit product and found it contains undisclosed tadalafil, or a combination of tadalafil and sildenafil, active ingredients in FDA-approved prescription drugs for erectile dysfunction.  The agency warned these ingredients may interact with other medicines such as the nitrates found in some prescription medicines such as nitroglycerin, and may lower blood pressure to dangerous levelsmen with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates and would be especially susceptible to contraindication with tadalafil or sildenafil.

FDA emphasized the counterfeit ExteZe is illegal and unsafe and advised consumers to avoid any product bearing this brand name and lot number 1110075 or F050899. The agency urged consumers who have an ExtenZe product to check for these lot numbers on the package and stop taking any product with either of these lot numbers, in addition to contacting their health care professional with any negative side effects.

"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, deputy director of the Office of Compliance in the FDA's 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."