Sexual Enhancement Supplement Contains Unapproved Medication, Says FDA

Sexual Enhancement Supplement Contains Unapproved Medication, Says FDA

April 23, 2015

A sexual enhancement supplement sold online and in some retail stores contains unapproved medications, says the Food and Drug Administration (FDA).

The FDA is advising consumers not to purchase or use Extreme Diamond 3000 after a laboratory analysis confirmed that the supplement is structurally similar to Viagra.

Extreme Diamond 3000 contains desmethyl carbodenafil and dapoxetine. Desmethyl carbodenafil is structurally similar to sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for erectile dysfunction (ED).

This undeclared ingredient 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.

Health care professionals and patients are encouraged to report adverse events or side effects
related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.