U.S. marshalls seize illegally marketed ED drug

7/25/2008

WASHINGTON U.S. Marshals recently seized nearly $74,000 worth of Xiadafil VIP tablets, at the request of the Food and Drug Administration. Although marketed as a dietary supplement to treat erectile dysfunction and for sexual enhancement, the lots represent an illegally marketed drug containing an undeclared ingredient.

On May 27, the FDA requested SEI Pharmaceuticals to recall the lots of Xiadafil VIP tablets. The company, however, refused to recall the products, making the seizure action necessary to prevent additional, illegal Xiadafil VIP products from entering the marketplace.

On April 22, the FDA initiated an inspection at SEI Pharmaceuticals following its analysis of the Xiadafil VIP tablets. The company was advised of the FDA’s findings and informed of the potential adverse health risks the product posed to unsuspecting consumers. The FDA also warned the company of possible legal actions, including seizure and/or injunction if corrective and preventive actions were not implemented. Although the company committed to halting distribution of the product and deactivated its Internet site, it refused to recall the product already in the market.

The FDA’s chemical analysis of Xiadafil VIP tablets found that the product contains hydroxyhomosildenafil, which is chemically similar to sildenafil. Sildenafil is the active ingredient in Viagra. The FDA has not approved Xiadafil VIP for ED or any other drug use, and the safety and effectiveness of this product is unknown. Although offered for sale as dietary supplements, the seized articles are new drugs that may not be introduced into interstate commerce without an approved new drug application filed with FDA.

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