As part of its initiative to alert its members to relevant safety alerts issued by the U.S. Food and Drug Administration (FDA), the American Urological Association announced several recent notices concerning undeclared ingredients in sexual enhancement supplements. XZen 1200, XZone Premium, XZen Gold, and XZen XPress contain sildenafil and tadalafil, the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction (ED). Wood-E contains sildenafil, the active ingredient in the FDA approved prescription drug Viagra. These undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
The AUA urges its members to alert patients about the harms of these and other supplements known to contain undeclared ingredients. Patients should be advised to discard unused supplements and to contact the FDA if they experience adverse events or side effects.
Over the last several months, the FDA has posted other alerts, which were reported in the Health Policy Brief. For more information on this or previous alerts, contact Quality@AUAnet.org.