FDA Warns Against Use of Xiadafil for Sexual Enhancement or Erectile Dysfunction

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FDA Warns Against Use of Xiadafil for Sexual Enhancement or Erectile Dysfunction

On May 27, the U.S. Food and Drug Administration (FDA) recently issued a warning against use of Xiadifil, which is sold as a dietary supplement for sexual enhancement or treatment of erectile dysfunction. The product contains an analog of sildenafil (Viagra) that can interact with other drugs to cause a dangerous decrease in blood pressure. The FDA has requested that the manufacturer recall the product.

Below is the text of the agency's recent MedWatch announcement:

Xiadafil VIP Tablets

FDA has alerted consumers and healthcare professionals not to buy or use Xiadafil VIP Tablets sold in bottles of 8 tablets (Lot #6K029) or blister cards of 2 tablets (Lot #6K029-SEI). The product is marketed as a dietary supplement and is promoted and sold over the Internet for sexual enhancement and to treat erectile dysfunction (ED).

The product contains a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. Xiadafil VIP Tablets contain hydroxyhomosildenafil, an analog of sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for ED.

The undeclared ingredient may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Consumers who have used the product should discontinue use immediately and consult their healthcare professional if they have experienced any adverse events that they believe may be related to the use of this product.

Read the May 27, 2008 MedWatch Safety Summary, including a link to an FDA news release regarding this issue.

5/30/08

Source
U.S. Food and Drug Administration. FDA MedWatch. May 27, 2008.