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FDA warns fake erectile dysfunction supplement may harm men

Teresa Tanoos's picture
FDA warns that fake male sexual enhancement product

The U.S. Food and Drug Administration (FDA) issued a warning today that a counterfeit dietary supplement for male sexual enhancement may be especially dangerous for men who have existing health conditions, including diabetes, heart disease, high blood pressure and high cholesterol.

The fake product is sold under the brand-name "ExtenZe Maximum Strength" and is similar looking to the actual product, ExtenZe. However, the FDA website reports that the counterfeit can be identified by lot number 0512058 and the expiration date of May 16, which is stamped on the outside of the package as EXP: May 16.

Analysis by the FDA discovered that the fake version of ExtenZe contains sildenafil, an ingredient found in FDA-approved erectile dysfunction drugs like Viagra, which cannot be obtained without a prescription.

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The actual ExtenZe product does not contain sildenafil, so it can be purchased without a prescription. But the counterfeit version, ExtenZe Maximum Strength, which does contain sildenafil, is also being sold without a prescription even though one is required by law.

This poses a risk to unsuspecting men who think they’re buying a safe male enhancement product when, in fact, it’s a counterfeit containing a prescription ingredient that may cause a dangerous drop in blood pressure because sildenafil can interact with nitrates, which are found in certain drugs commonly prescribed for men with diabetes, heart disease, high blood pressure and/or high cholesterol.

The FDA is recommending consumers who have purchased ExtenZe to look on the outside of the package for the lot number to make sure it’s not the counterfeit version. If the lot number is identified as 0512058 and has an expiration date of May 16, that indicates the product is a fake.

If you have the counterfeit product, the agency is advising that you stop taking the product. If you are having any negative side effects, the FDA recommends contacting your physician immediately.

SOURCE: U.S. Food and Drug Administration (FDA), "FDA warns about counterfeit ExtenZe dietary supplements", published Nov. 12, 2013.