FDA warns consumers not to use Vigor-25

Monday, 22 November 2010

The U.S. Food and Drug Administration says Vigor-25, a product 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.

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.

Vigor-25, distributed by Piston Corp., is sold on Internet sites and possibly 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 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."

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 24-72 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 health care professional and to safely discard the product. The FDA urges health care professionals and consumers to report adverse events or side effects from use of Vigor-25 to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax:

Complete and submit the report online: www.fda.gov/MedWatch/report.htm
Download form or call 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 800-FDA-0178

Consumers also are urged to report suspected criminal activity regarding sexual enhancement products, including Vigor-25, to the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by reporting it on the OCI website at www.fda.gov/OCI.