Consumers Warned About ExtenZe Dietary Supplements

The Food and Drug Administration (FDA) has warned consumers to steer clear of a counterfeit version of the dietary supplement called ExtenZe, which is marketed for male sexual enhancement.

The agency says the knock-off pills contain the active ingredients in Viagra, though they aren't listed on the label. The FDA said the supplements can cause serious harm to some consumers.

"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."

If all this sounds vaguely familiar, it should. Biotab Nutraceuticals, Inc. (“Biotab”) recalled two lots of ExtenZe nutritional supplement tablets back in late February for the very same reason. The two lots that were recalled them contained the unlisted active ingredients in Viagra.

Both Health care professionals and consumers are being encouraged to remain aware of any adverse events or side effects related to the use of these products and report them to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/MedWatch/report.htm 

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, such as Viagra.

The danger is, 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.

Biotab, the marketer of ExtenZe, draws consumer complaints for its marketing practices as well.

“I ordered a seven day trial of the product Extenze for 97 cents and was immediately billed for $50.00 the same evening,” Wayne, of Kankakee, Ill., told ConsumerAffairs.com back in August.