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May29
Xiadafil Recalled By FDA

The U.S. Food and Drug Administration has issued an immediate recall of all Xiadafil VIP Tabs that were sold in 8 tablet bottles( Lot #6K029) or blister packs of two (Lot #6K029-SEI) due to the fact that they contain a potentially harmful, undeclared ingredient.

The undeclared ingredient "may dangerously affect a person's blood pressure and can cause other life-threatening side effects." While Xiadafil is labeled as a dietary supplement that is "all-natural" it is illegally marketed as a drug for the treatment of erectile dysfunction and for sexual enhancement.

Xiadafil.jpgFDA chemical analysis found that Xiadafil contains an analog of sildenafil, the active ingredient in Viagra that may interact with ingredients in other prescribed medications. It can also have a life-threatening effect by significantly lowering blood pressure.

"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."

[Source: U.S. Food and Drug Administration]

 


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« Promacta Fails to Control Bleeding According to FDA | Main | Wyeth Receieves Approvable Letter from FDA »

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