Today, the U.S. Food and Drug Administration (FDA) requested that SEI Pharmaceuticals of Miami, Florida recall all Xiadafil VIP Tabs sold in eight tablet bottles (Lot # 6K029) or blister cards of two tablets (Lot # 6K029-SEI). Florida officials issued a “stop sale” action at SEI’s Miami distribution facility on May 13 that required SEI to hold—intact—violative Xiadafil VIP Tabs found on-hand at the facility.
The Xiadafil VIP Tabs contain a potentially harmful, undeclared ingredient found in the prescription drug Viagra that may dangerously affect a person’s blood pressure as well as cause other life-threatening side effects. The lots of Xiadafil VIP Tabs containing the potentially dangerous ingredient, bear an expiration date of September 2009 (09/09). Xiadafil VIP Tabs are marketed as a dietary supplement for sexual enhancement and claim to treat erectile dysfunction (ED).
According to the FDA, today’s formal request by the agency follows an action by the state of Florida to prevent the further distribution of the Xiadafil VIP Tabs into consumer channels. The FDA is advising consumers not to buy or use this product. The FDA said it might take further regulatory action to protect consumers from this illegal product.
Xiadafil VIP Tabs are labeled as a dietary supplement and hyped as “all-natural”; however, according to the FDA, Xiadafil VIP Tabs are, in fact, an illegally marketed drug that contains a potentially harmful undeclared ingredient. The FDA said its chemical analysis revealed that Xiadafil VIP Tabs contains hydroxyhomosildenafil, which is an analog of sildenafil, the active ingredient in Viagra. Viagra is an FDA-approved prescription drug for ED.
Hydroxyhomosildenafil may interact with nitrates found in some prescription drugs—such as nitroglycerin, for example—and can also lower blood pressure to life-threatening levels. People 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 said it has not approved Xiadafil VIP Tabs for any use and its safety and effectiveness is unknown. The product is promoted and sold over the Internet, was given away as free samples at trade shows, is sold in health food stores nationwide, and may be distributed in either bottles of eight tablets or blister cards of two tablets.
According to the FDA, alternative products such as 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 be aware that the FDA has not verified the safety, efficacy, and purity of such ingredients.
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