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SEI Pharmaceuticals facing FDA legal action

The US Food and Drug Administration has asked SEI Pharmaceuticals in California to recall all batches of its illegally marketed drug, Xiadafil VIP Tabs
The US Food and Drug Administration (FDA) has asked SEI Pharmaceuticals in California to recall all batches of its illegally marketed drug, Xiadafil VIP Tabs.

The FDA has revealed that Xiadafil VIP Tabs, marketed for the treatment of erectile dysfunction (ED), contain a potentially life-threatening undeclared ingredient. Consumers are being urged not to buy the drug, which has been labelled as a natural dietary supplement, leading people to believe that it is harmless.

The FDA said: "The agency may take further action to protect consumers from this illegal product."

Tests of the product conducted by the agency revealed that it contained chemicals usually found in Viagra, which is already authorised by the FDA. Xiadafil has not been approved for any drug uses, including the treatment of ED. It was distributed and sold over the internet, at health food stores across the US and given away as free samples at trade shows.

Dr Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said: "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, officials in Florida issued SEI with a 'stop sale' action at its facility in Miami, which forced it to hold back volatile batches of Xiadafil. This new request from the FDA signals a focused effort by US government officials to ensure the product does not fall into the hands of unsuspecting members of the public.

28th May 2008

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