FDA Announces Warnings against Certain Sexual Enhancement Supplements

FDA Announces Warnings against Certain Sexual Enhancement Supplements

December 29, 2015

The Food and Drug Administration (FDA) has released its latest batch of public notifications, warning consumers against the purchase and use of dangerous supplements promoted and sold for sexual enhancement. Released on December 28, 2015, each notification comes after FDA laboratory analysis confirmed the presence of dapoxetine, desmethyl carbodenafil, sildenafil, and/or tadalafil.

Sildenafil and tadalafil, the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, are used to treat erectile dysfunction (ED). These 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.

Desmethyl carbodenafil is structurally similar to sildenafil and may also react dangerously with nitrates.

Dapoxetine is an active ingredient not approved by FDA, and therefore its safety and efficacy have not been established.

The FDA is warning customers to avoid use of the following supplements:

  • Eros Power Zone 1900: dapoxetine, desmethyl carbodenafil
  • Triple MiracleZen Extreme: dapoxetine, sildenafil, tadalafil
  • Diamond 3500: sildenafil, tadalafil
  • Rhino Big Horn 3000: desmethyl carbodenafil, sildenafil
  • Rhino 7 Blue 9000: tadalafil
  • OrgaZen 3000: tadalafil
  • Triple MiracleZen Gold: dapoxetine, sildenafil, tadalafil
  • Triple Power Zen Plus 2000: sildenafil, tadalafil
  • Triple Power Zen Gold 2000: sildenafil, tadalafil
  • Xtra Zone 2200: sildenafil, tadalafil
  • Xtra Zone 2400: sildenafil, tadalafil
  • Xtra Zone 2600: sildenafil, tadalafil
  • OrgaZen 3500: tadalafil