[11-12-2013] The U.S. Food and Drug Administration is warning consumers about a potentially harmful counterfeit dietary supplement for male sexual enhancement, represented as “ExtenZe Maximum Strength.” The counterfeit product looks similar to the actual product, but 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.
FDA laboratory analysis confirmed that the counterfeit EntenZe product contains sildenafil, an active ingredient in FDA-approved prescription medicines for erectile dysfunction. This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
The counterfeit product was purchased online but may also be available from other sources. FDA is advising consumers who have an ExtenZe product to check the lot number on the package to make sure they do not have a counterfeit product. Consumers who think they might have the counterfeit product should:
- stop taking the product; and
- contact their health care professional if they are experiencing any negative side effects.
Health care professionals and consumers are encouraged to report any adverse events or side effects related to the use of these products to FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Consumers can report adverse events by completing and submitting the Consumer Reporting Form FDA by:
- fax the form to 1-800-332-0178; or
- mail the form FDA using the address listed on the form
Health care professionals can report adverse events through FDA’s MedWatch Adverse Event Reporting program by:
- completing and submitting the report online at www.fda.gov/medwatch/report.htm; or
- downloading and completing the form, then submit it via fax at 1-800-FDA-0178.