FDA issues warning over use of dietary supplements containing sildenafil

SILVER SPRING, Md. — The Food and Drug Administration on Friday reported that Vigor-25, a product inappropriately marketed as a natural dietary supplement to enhance male sexual performance, should not be purchased or used because it contains sildenafil, the active ingredient in the prescription drug Viagra.

“This product is dangerous to consumers because it claims to contain only natural ingredients when it actually contains a prescription drug ingredient,” stated Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Tainted products place consumers at risk of injury and death, especially those consumers with underlying health conditions.”

Vigor-25, distributed by Piston, is sold on Internet sites and possibly in some retail outlets, the FDA reported.

Sildenafil may interact with prescription drugs known as nitrates, including nitroglycerin, and can dangerously lower blood pressure. The FDA is investigating the reported death of a 26-year-old man, possibly associated with the use of Vigor-25.

The FDA has found many products marketed as dietary supplements for sexual enhancement during the past several years that can be harmful because they contain active ingredients in FDA-approved drugs or variations of these ingredients. Sexual-enhancement products promising rapid effects (e.g., claim to work in minutes to hours) or long-lasting effects (e.g., claim to last 24 to 72 hours) likely contain a contaminant, the FDA stated.