The 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.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm369724.htm
