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Xiadafil VIP Tablets Seized by FDA Legal Evaluation

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Xiadafil VIP Tablets Seized by FDA

July 2008

Xiadafil tablets illegally marketed The U.S. Food and Drug Administration (FDA) has ordered the seizure of certain lots of Xiadafil VIP tablets. The drugs are described as a dietary supplement for treating erectile dysfunction (ED) and sexual enhancement, but the FDA says that the seized tablets have been illegally marketed and contain a potentially harmful undeclared ingredient.

The FDA has found that the tablets contain an ingredient similar to sildenafil, which is the active ingredient in the FDA-approved ED drug Viagra. However, the FDA has not approved Xiadafil VIP for ED or any other use, and its safety and effectiveness are unknown. The drug was distributed at trade shows and sold in eight tablet bottles, lot 6K209, and two tablet blister cards, lot 6K209-SEI, with the expiration date Sept. 2009.

The FDA first ordered the recall of the Xiadafil VIP tablets in May 2008, but the drug’s distributer, SEI Pharmaceuticals, refused to recall the medication. Erectile dysfunction is common in men who suffer from diabetes, high blood pressure, high cholesterol, or heart disease. Because of these medical conditions, men may seek drugs like Xiadafil VIP that are marketed as "all natural" and free of the active ingredients of prescription drugs.

Source: "Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product." U.S. Food and Drug Administration. July 24, 2008.

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