FDA warns of undeclared ingredient in Vigor-25

The FDA has notified consumers and healthcare professionals that Vigor-25 (from Piston Corp.), a product marketed as a natural dietary supplement to enhance male sexual performance, should not be purchased or used because it contains undeclared sildenafil, the active ingredient in the prescription drug Viagra (from Pfizer). Sildenafil may interact with prescription drugs known as nitrates (eg, 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 (eg, claim to work in minutes to hours) or long-lasting effects (eg, claim to last 24-72 hours) are likely to contain a contaminant. The FDA advises consumers who have experienced any negative side effects from sexual enhancement products to stop using such products and consult a healthcare professional and to safely discard the product.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm234460.htm.