The FDA is advising consumers not to purchase or use the following products that are promoted and sold on various websites and in some retail stores for sexual enhancement:
- Xzen XPress
- X-Zone Premium
FDA laboratory analysis confirmed that these products contained either one or more of the following active ingredients: sildenafil, tadalafil, and dapoxetine.
Sildenafil and tadalafil are the active ingredients in the FDA-approved erectile dysfunction drugs Viagra (Pfizer) and Cialis (Lilly), respectively. Dapoxetine is not FDA-approved, and so its safety and efficacy have not been established.
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.
Consumers are to stop using these product immediately and throw them away.
For more information call (800) 332-1088 or visit the FDA’s Tainted Sexual Enhancement Products page.