[Posted 09/24/2013]

AUDIENCE: Consumer

ISSUE: FDA is advising consumers not to purchase or use XZone Premium, a product promoted and sold for sexual enhancement. FDA laboratory analysis confirmed that XZone Premium contains sildenafil, tadalafil, and dapoxetine. Sildenafil and tadalafil are the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, 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. Dapoxetine is an active ingredient not approved by FDA, and therefore its safety and efficacy have not been established.

BACKGROUND: XZone Premium is sold on various websites and in some retail stores.

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.

[09/24/2013 - Public Notification - FDA] [09/24/2013 - Tainted Sexual Enhancement Products - FDA]  

-