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FDA Warning: 'ExtenZe Maximum Strength' Is Counterfeit

Nov 13, 2013

Federal health officials are warning about the presence of a counterfeit male sexual enhancement supplement widely available to consumers.

This week, the U.S. Food and Drug Administration (FDA) warned that ExtenZe Maximum Strength is a counterfeit product that contains sildenafil. Sildenafil is the active ingredient used in prescription male sexual enhancement drugs like Viagra, which is used for erectile dysfunction. According to a Reuters report on the warning, the FDA says that ExtenZe Maximum Strength is not made by the same company that produces ExtenZe, a highly promoted supplement found in pharmacies and retail locations over-the-counter.

Regulators warn that ExtenZe Maximum Strength containing sildenafil could trigger a life-threatening drug interaction if it’s taken by men already prescribed and taking drugs containing nitrates. Nitrates are commonly found in prescription drugs men take for the treatment of diabetes and other common conditions, such as heart disease, Reuters adds.

The FDA notes that consumers will be able to differentiate the counterfeit ExtenZe product from the real one—manufactured by Biotab Neutraceuticals Inc.—by the lot code and expiration date printed on the packages of ExtenZe Maximum Strength. The counterfeit and dangerous product will be marked with the lot number 0512058, and the expiration date will be May 16, Reuters notes.

Officials warn consumers who may be taking the counterfeit version of ExtenZe to stop doing so immediately and to contact their physician to determine if they are at risk of any dangerous drug interactions.

Based on our previous reports, the FDA has been cracking down on the makers of bogus dietary supplements over the past few years and has already seized millions of products. Although the FDA generally does not have jurisdiction over dietary supplements and their manufacturers, recent changes in regulatory law have allowed the agency some reach over this market.

Counterfeit, and what the FDA considers dangerous, dietary supplements like ExtenZe Maximum Strength often contain undeclared active pharmaceutical ingredients. These products may interact with medications that a person may be taking. Since the presence of these ingredients in counterfeit products is typically not listed on product packaging, a consumer has no way of knowing if what they are taking presents any danger, according to our reports.

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