FDA Issues Warning on Sex Product

SILVER SPRING, Md.FDA issued a consumer warning regarding Vigor-25, a product marketed as a dietary supplement for male sexual performance that in fact contains sildenafil, the active ingredient in the prescription drug Viagra. Sildenafil can interact with other prescription drugs causing dangerous side effects. The agency said it is investigating the reported death of a 26-year-old man, possibly associated with the use of Vigor-25, which is distributed by Piston Corp. and sold on Internet sites and in some retail outlets.

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

FDA advised consumers who have experienced any negative side effects from sexual enhancement products to stop using such products and consult a health care professional and to safely discard the product. Consumers and health care professionals can report adverse events from the use of Vigor-25 to the MedWatch Adverse Event Reporting program online.