Product contains undeclared ingredient that puts consumer health at risk
The U.S. Food and Drug Administration today requested that SEI Pharmaceuticals, of Miami, Fla., recall all Xiadafil VIP Tabs sold in 8 tablet bottles (Lot # 6K029) or blister cards of 2 tablets (Lot # 6K029-SEI) because these products contain a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. These lots of Xiadafil VIP Tabs bear an expiration date of September 2009 (09/09). Xiadafil VIP Tabs are marketed as a dietary supplement for sexual enhancement and able to treat erectile dysfunction (ED).
Today's formal request follows an action by the state of Florida to prevent the further distribution of this product into consumer channels. FDA is advising consumers not to buy or use this product. The agency may take further regulatory action to protect consumers from this illegal product.
Although labeled as a dietary supplement and touted as "all-natural," Xiadafil VIP Tabs are an illegally marketed drug that contains a potentially harmful undeclared ingredient. FDA chemical analysis revealed that Xiadafil VIP Tabs contains hydroxyhomosildenafil, which is an analog of sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for ED.
This undeclared ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these medical conditions.
"Because these products are labeled as ‘all natural dietary supplements,' consumers may assume that they are harmless and pose no health risk," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "But an unsuspecting consumer with underlying medical issues may take these products without knowing that they can cause serious side effects and interact in dangerous ways with drugs that a consumer is already taking."
The FDA has not approved Xiadafil VIP Tabs for ED or any other drug use, and the safety and effectiveness of this product is unknown. The product is promoted and sold over the Internet, was given away as free samples at trade shows, and is sold in health food stores nationwide. The product may be packaged in bottles of eight tablets or blister cards of two tablets.
On May 13, 2008 Florida officials issued a "stop sale" action at SEI's distribution facility in Miami, Fla. This action required the firm to hold, intact, violative Xiadafil VIP Tabs found on-hand at the facility. The state of Florida's action to control the supply of the product, coupled with today's formal request by FDA to recall this product from the marketplace, will further reduce the likelihood that this potentially dangerous product is used by unsuspecting consumers.
Alternative products like Xiadafil VIP Tabs are often sought out because they are marketed as "all natural" or as not containing the active ingredients in approved, prescribed ED drugs. Because the manufacturing source of the active ingredients in many of these alternative products is unknown, consumers should also be aware that the safety, efficacy, and purity of these ingredients have not been verified by the FDA.
The FDA advises consumers who have used this product to discontinue use immediately and consult their health care professional if they have experienced any adverse events that they believe may be related to the use of this product.
Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 or online at www.fda.gov/medwatch/report.htm.
Additionally, the FDA recommends that consumers talk to their health care professional about FDA-approved treatments for ED.
For more information, visit: www.fda.gov/consumer/updates/erectiledysfunction010408.html.