Herbal sex pill alternatives pose hidden dangers

LOS ANGELES -- Many of the 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 even death.

"All-natural" 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 the same pharmaceuticals they are supposed to replace.

That represents a special danger for the millions of men who take nitrates -- drugs prescribed to lower blood pressure and regulate heart disease. When mixed, nitrates and impotency pharmaceuticals can slow blood flow catastrophically, leading to a heart attack or stroke.

Problem not tracked

An Associated Press investigation shows that spiked herbal impotency pills are emerging as a major public health concern that officials haven't figured out how to track, much less tame.

Emergency rooms and poison control hot lines are starting to log more incidents of the long-ignored phenomenon. Sales of "natural sexual enhancers" are booming -- rising to nearly $400 million last year. And dangerous knockoffs abound.

At greatest risk are the estimated 5.5 million American men who take nitrates -- generally older and more likely to need help with erectile dysfunction.

The all-natural message can be appealing to such men, warned by their doctors and ubiquitous TV commercials not to take Viagra, Cialis or Levitra.

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 -- some with doses more than twice that of prescription erectile dysfunction medicine. Other testers report similar results, particularly among pills that promise immediate results.

While no deaths have been reported, the AP found records of emergency room visits attributed to all-natural sex pills in Georgia, Chicago, Philadelphia, San Diego and elsewhere.

An elderly man in a retirement community north of Los Angeles took an in-the-mail sample and landed in the hospital for four days. A Michigan man sued the maker of Spontane-ES, blaming it for the stroke he suffered 20 minutes after taking a free pill that was advertised as "extremely safe." Tim Fulmer, a lawyer representing Spontane-ES, said the pill did not contain any pharmaceutical and was not responsible for the stroke.

Numbers increasing

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 on the Internet and the desperation of vulnerable men. He said he wouldn't be surprised if there'd been undetected deaths from bad herbal pills.

Some herbal labels warn off users with heart or blood-pressure problems if they have taken their medicine within six hours; some doctors say 24 hours or more would be safer.

The AP often couldn't determine from records whether incidents reported to tracking systems of the federal Food and Drug Administration and state poison control centers involved mixing herbal alternatives with nitrates.

Some men in their 30s who went to emergency rooms after taking herbal sex pills were presumably otherwise healthy, but they showed the transitory side effects of the active ingredients in regulated impotency pharmaceuticals, such as difficulty seeing clearly or severe headaches, records show.

While public health officials don't know the extent of the problem, they agree that incidents are vastly underreported, with national tracking systems capturing perhaps as little as 1 percent of them. Victims may be embarrassed, and doctors rarely ask about supplements.

A growing industry

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.

"The Internet poses many enforcement challenges," said Dr. Linda Silvers, who leads an FDA team that targets fraudulent health products sold online. "A Web site can look sophisticated and legitimate, but actually be an illegal operation."

In many cases, the ingredients used to alter herbal pills come from Asia, particularly China, where the sexual enhancers are cooked up in labs at the beginning of a winding supply chain. The FDA has placed pills by two manufacturers in China and one from Malaysia on an import watch list.