[Posted 09/24/2013]

AUDIENCE: Consumer, Health Professional

ISSUE: FDA is advising consumers not to purchase or use Xzen 1200, Xzen Gold or Xzen XPress products promoted and sold for sexual enhancement on various websites and in some retail stores. FDA laboratory analysis confirmed that Xzen 1200 contains tadalafil, the active ingredient in the FDA-approved prescription drug Cialis,and that Xzen Gold and Xzen XPress contain both sildenafil and tadalafil, the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, which are used to treat erectile dysfunction (ED). These undeclared ingredients 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.

BACKGROUND: Xzen 1200, Xzen Gold and Xzen XPress are sold on various websites and in some retail stores. These products are typically promoted for sexual enhancement, weight loss, and body building, and are often represented as being “all natural.”

RECOMMENDATION: Consumers should stop using this product immediately and throw it away.  Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[09/24/2013 - Xzen 1200 Public Notification - FDA] [09/24/2013 - Xzen Gold Public Notification - FDA] [09/24/2013 -Xzen XPress Public Notification - FDA] [09/24/2013 - Tainted Sexual Enhancement Products - FDA]

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