Posted on Nov 14, 2013

Counterfeit dietary supplements somehow make it into the market. Now the FDA has issued a warning stating that one particular male sexual enhancement dietary supplement is counterfeit.

NBC reports on the counterfeit supplement. “The Food and Drug Administration warned on Tuesday of a counterfeit dietary supplement for male sexual enhancement that could be particularly harmful to patients with diabetes, high blood pressure, high cholesterol and heart disease,” according to NBC.            

The FDA officially posted the warning on Tuesday. The warning states, “The fake product is represented as "ExtenZe Maximum Strength" and looks similar to the actual product, ExtenZe, which is made by Monrovia, Calif.-based Biotab Nutraceuticals.” NBC reports, “The FDA said its analysis showed that the counterfeit ExtenZe contains sildenafil, an active ingredient in various FDA-approved prescription medicines, including Pfizer's Viagra, for erectile dysfunction. (Biotab's ExtenZe does not contain sildenafil, which cannot be taken without a prescription. The counterfeit product is available online and elsewhere without a prescription.”

The FDA warns that, “Sildenafil may interact with nitrates — found in some prescription drugs and often taken by men with diabetes, high blood pressure, high cholesterol, or heart disease — and could lower blood pressure to dangerous levels.” Biotab has not issued a statement at this time. The company has had multiple problems such as last year when it had to issue a recall because the FDA found ‘undeclared drug ingredients’ in its products. And in Canada, “The Canadian health regulator warned in June against various unauthorized and "dangerous" ExtenZe products found at a retailer in Calgary that could pose serious health risks,” according to NBC.

The FDA is urging consumers to be careful and not take the supplement for now. NBC reports, “The FDA said the fake product can be identified by lot number 0512058 and the expiration date, "EXP. May 16," stamped on the outer carton and embossed on the blister card. Customers with such counterfeit ExtenZe should stop taking the supplement immediately and contact their healthcare professional, the agency advised on Tuesday.”

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Gerry Oginski
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