FDA Requests Sex Supplement Recall

WASHINGTON—FDA requested Miami-based SEI Pharmaceuticals recall all Xiadafil VIP Tabs because these products, marketed as a dietary supplement for sexual enhancement and able to treat erectile dysfunction (ED), contain a potentially harmful, undeclared ingredient that may dangerously affect blood pressure. The lots requested for recall—eight-tablet bottles (Lot # 6K029) and two-tablet blister cards (Lot # 6K029-SEI)—bear an expiration date of September 2009 (09/09). FDA is advising consumers not to buy or use this product, and the agency is considering further action.

FDA's request followed a similar action by Florida state officials, which issued a "stop sale" action at SEI's distribution facility in Miami on May 13, requiring the firm to hold intact any Xiadafil VIP Tabs found on-hand at the facility.

Xiadafil VIP Tabs are labeled as a dietary supplement and touted as all-natural, but FDA called the products illegally marketed drugs containing an undeclared pharmaceutical ingredient. FDA’s chemical analysis found Xiadafil VIP Tabs contain undeclared hydroxyhomosildenafil, an analog of sildenafil, the active ingredient in Viagra.

The agency warned the undeclared ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to life-threatening levels.

"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 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."

FDA advised 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 practitioners are encouraged to report any adverse events related to Xiadafil Tabs to the agency's MedWatch program.