LOS ANGELES — Many pills marketed as safe herbal alternatives to Viagra and other prescription sex medications pose a hidden danger: For men on common heart and blood-pressure drugs, popping one could lead to a stroke or death.
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Products with names like Stamina-RX and Vigor-25 promise an apothecary's delight of rare Asian ingredients, but many work because they contain unregulated versions of substances they are supposed to replace.
That dirty secret represents a special danger for the millions of men who take nitrates — drugs prescribed to lower blood pressure and regulate heart disease.
Risk of overdose
When mixed, nitrates and impotency pharmaceuticals can slow blood flow catastrophically, leading to a heart attack or stroke.
James Neal-Kababick, director of Oregon-based Flora Research Laboratories, said about 90 percent of the hundreds of samples he has analyzed contained forms of patented pharmaceuticals.
Mark B. Mycyk, a Chicago emergency room doctor who directs Northwestern University's clinical toxicology research program, said he is seeing increasing numbers of patients who unwittingly took prescription-strength doses of the alternatives, a trend he attributes to ease of purchase.
Background
•Since 2001, sales of supplements marketed as natural sexual enhancers have risen $100 million, to $398 million last year, including herbal mixtures, according to estimates by Nutrition Business Journal.
•Some legitimate herbal mixtures claim to work gradually over weeks; it's the herbals marketed for immediate trysts that often are the problem.
•Tight budgets, weak regulations and other priorities limit the FDA's ability to police the products, often promoted via blasts of e-mail spam and fly-by-night Web sites.
•In many cases, the ingredients used to alter herbal pills come from Asia, particularly China.
Different regulations
•Under U.S. law, because such pills are "dietary supplements,” they're far less regulated than pharmaceuticals and face few barriers to market. Viagra, by contrast, underwent years of testing before it became available.
•Federal officials have only recently stepped up investigations and prosecutions.
•In any case, the FDA's recall power is limited. Last week, in response to an increase in safety concerns about imported toothpaste, dog food and toys originating in China, President Bush recommended that the FDA be authorized to order mandatory recalls of products determined to be dangerous.
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FDA cracks down on ‘herbal' pills
During the past year, the FDA has orchestrated eight recalls of "herbal” pills that contained the ingredients found in Viagra, Cialis or Levitra, or their unregulated chemical cousins.
•One recall involved a pill called Liviro3. The distributor said he bought the brand name and several thousand pills in 2004 for $450,000. In January, FDA agents seized his stockpile after a lab found that Liviro3 contained tadalafil, the main ingredient in Cialis. The man told the AP he'd had no idea the pills were drug-laced.
•One prosecution involved V. Vigor Corp., the Long Island-based maker of Vigor-25. While the product was advertised as containing Asian ginseng, lycium fruit and Chinese yam rhizome, FDA testing indicated that the pills contained Viagra.
•Two other pills, Spontane-ES and Stamina-RX, were made by companies run by Jared Wheat, who's facing federal charges in Atlanta that he peddled knockoff pharmaceuticals cooked in a Central American lab.
The Associated Press
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