The U.S. Food and Drug Administration (FDA) just issued a warning to consumers about a potentially dangerous bogus supplement misrepresented as “ExtenZe Maximum Strength,” a male sexual enhancement product.
The fake “ExtenZe Maximum Strength” looks similar to the authentic product. The fake bears lot number 0512058 and expiration date EXP. May 16, which are both stamped on the product’s outer carton and embossed on the blister card.
FDA laboratory analysis confirmed that the counterfeit ExtenZe product contains sildenafil, which is an active ingredient in FDA-approved prescription medicines for erectile dysfunction (ED). The undeclared sildenafil may interact with nitrates found in some prescription medications such as nitroglycerin. Sildenafil may also lower blood pressure to dangerous levels.
Men diagnosed with diabetes, high blood pressure, high cholesterol, or heart disease are often prescribed nitrates, the FDA noted.
The fake product was sold online and was also possibly available from other sources.
The FDA advises consumers in possession of an ExtenZe product to check the packaging on the lot number to confirm that they do not have the counterfeit product.
Consumers in possession of the bogus product should stop taking the fake supplement and contact their health care professional should they experience any negative side effects.
ExtenZe is manufactured by Biotab Nutraceuticals Inc. of Monrovia, California, according to Reuters. The actual ExtenZe does not contain sildenafil, which can only be taken with a prescription. The counterfeit product was sold without a prescription.
Biotab previously initiated a voluntary recall of two lots of ExtenZe products after the FDA advised the drug maker that those lots contained “undeclared drug ingredients” that could possibly be dangerous, according to Reuters.
The Canadian health regulator also issued a warning this June advising consumers against taking unauthorized and “dangerous” ExtenZe products, after counterfeit product was discovered at a retailer in Calgary. Consumers were advised that the fake product could pose serious health risks, Reuters wrote.
Biotab has previously explained that despite its efforts to stop counterfeit and adulterated product purporting to be authentic ExtenZe from entering the country, some pirate product does get through United States Customs. Biotab notes that the best way in which to ensure authentic Biotab is purchased is to only purchase the product from Biotab or its limited authorized distributors.