FDA warns of fake dietary supplements

ExtenZeThe US Food and Drug Administration (FDA) is warning consumers about a counterfeit product sold as ExtenZe, a genuine dietary supplement for male sexual enhancement.

Some of the fake product has been laced with tadalafil, the active ingredient in Eli Lilly's prescription-only erectile dysfunction product Cialis. Others have been identified with a combination of tadalafil and sildenafil, the active ingredient in Pfizer's erectile dysfunction treatment Viagra.

"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," said the FDA in a statement.

Adding those ingredients is particularly hazardous because men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates, and are also a prime demographic for the use of this type of supplement product.

ExtenZe is a legally-marketed dietary supplement, based on herbal and nutritional ingredients, developed by Biotab Nutraceuticals. It is sold with implicit claims that it can improve sexual performance through "male enhancement."

"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."

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