FDA has warned consumers about counterfeit products respresented as ExtenZe, a dietary supplement for male sexual enhancement.

The counterfeit product looks similar to the actual product, but contains hidden ingredients that can cause serious harm to consumers. The counterfeit product has the following lot numbers on the packages:

• LOT 1110075
• LOT F050899

FDA laboratory analysis confirmed that the counterfeit product contains tadalafil, or a combination of tadalafil and sildenafil—active ingredients in FDA-approved prescription medicines for erectile dysfunction. These ingredients are not listed on the product label.

These ingredients may interact with other medicines, like the nitrates found in some prescription medicines 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.

The counterfeit product is illegal and unsafe. FDA is advising consumers not to purchase any products labeled as “ExtenZe” with lot numbers 1110075 and F050899. Consumers who have an ExtenZe product should check the lot numbers on the package to make sure they do not have a counterfeit product. Consumers who think they might have the counterfeit product should:

• stop taking the product; and
• contact their healthcare professional if they are experiencing 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.”

Healthcare professionals and consumers are encouraged to report any adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online: www.fda.gov/MedWatch/report.htm
• Download form or call 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 800-FDA-0178