July 26, 2008

FDA Seizes Drugs From Firm

By John Dorschner, The Miami Herald

Jul. 26--Federal agents have seized $74,000 worth of tablets from a Miami company that claimed it was making "an all-natural sexual stimulant" when in fact it was selling unapproved pills that contained a chemical similar to what's found in Viagra.

The Food and Drug Administration warned people it could be dangerous to take the tablets, which are sold under the brand name Xiadafil VIP, made by SEI Pharmaceuticals.

Not only is Xiadafil not tested and approved for use, the FDA said in a news release, but its chemical properties may be particularly dangerous for men with certain physical conditions who seek a natural solution for erectile dysfunction after being told by their doctors to avoid Viagra because of serious side effects.

A woman who answered the phone at SEI Pharmaceuticals on Friday said, "At the moment we have no comments." She refused to give her name.

Xiadafil was listed for sale Friday on several websites. FitFuel.com was offering eight tablets for $39.95. The product is intended for "24 hour maximum sexual enhancement," the website said. Listed ingredients included dogwood fruit, foxglove root, gingko biloba and Korean ginseng.

Not mentioned was hydroxyhomosildenafil, the ingredient the FDA says is in the tablets. It is similar to sildenafil, the active ingredient in Viagra.

The tablets fit a pattern of "natural" pills sold in Miami that secretly contain pharmaceutical drugs.

Three years ago, Brazilian diet pills were heavily used in South Florida. The pills, which were said by many to produce huge weight losses, claimed to be all-natural but in fact contained amphetamines and tranquilizers that are legal only through prescription.

Most of those pills were manufacturered in Brazil. In January 2006, three months after The Miami Herald reported problems with the pills, the FDA issued a public warning to consumers not to use the diet pills.

A Miami toxicologist, Terry Hall, who several years ago reported people were failing employment drug tests after taking Brazilian pills, said he had not seen any of the diet pills recently, although a few months ago he was asked by FDA investigators to provide information on the diet pills. Hall said he didn't know anything about Xiadafil.

FDA spokeswoman Rita Chappelle said the erectile-dysfunction pills weren't connected with the companies that made the Brazilian diet pills, but appear to be part of a trend of "undeclared drug ingredients in products positioned as dietary supplements."

Juan Carlos Paredes, a Miami Beach doctor, said tablets with hidden Viagra ingredients could be quite dangerous, even lethal, to persons taking nitrates for heart conditions. Those taking "party poppers" -- amyl nitrates -- may experience a sudden loss of consciousness if they add a Viagra-like tablet to the mix.

The FDA advised those experiencing adverse reactions from Xiadafil to consult a healthcare professional.

State records show SEI's president is Edward Miller. The firm is located at 3553 NW 50th St. Its answering machine states the company is a "manufacturer of the world's leading nutrition and pharmaceutical products."

Chappelle said SEI used a contract manufacturer somewhere in the United States to manufacture the tablets, using some ingredients imported from elsewhere.

The Xiadafil tablets were given away at places like the International Lingerie Show, or sold in bottles of eight tablets or blister cards of two tablets, the FDA said.

On April 22, the FDA inspected the SEI facility after testing Xiadafil and "warned the company of possible legal actions, including seizure and/or injunction if corrective actions were not implemented," according to the FDA.

SEI promised to halt distribution and it deactivated its website, but "it refused to recall the product already in the market."

On May 13, Florida issued a "stop sale" action for the product, requiring SEI to keep Xiadafil VIP tablets at its facility. On May 27, the FDA formally asked the company to recall the pills.

"The company . . . refused to recall these products," the FDA reported, "making the seizure action necessary to prevent additional, illegal Xiadafil VIP products from entering the marketplace."


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