FDA calls for recall of supplement marketed for ED

ROCKVILLE, Md. The 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 and are marketed as a dietary supplement for sexual enhancement and able to treat erectile dysfunction.

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, the FDA stated. 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.

“Because these products are labeled as ‘all natural dietary supplements,’ consumers may assume that they are harmless and pose no health risk,” stated Janet Woodcock, 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.”

On May 13 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.