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 very
pharmaceuticals 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. When mixed, nitrates and impotency
pharmaceuticals can slow blood flow catastrophically, leading to a
heart attack or stroke.
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 (¤274 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
The all-natural message can be appealing to such men, warned by
their doctors and ubiquitous TV commercials not to take Viagra, Cialis
90% contain pharmaceuticals
James Neal-Kababick, director of Oregon-based Flora Research
Laboratories, said about 90 percent of the hundreds of samples he has
analysed 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 freebie 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
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 centres 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.
Since 2001, sales of supplements marketed as natural sexual
enhancers have risen $100 million (¤68.6 million), to $398 million
(¤273 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.
Internet poses challenges
"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
Pills like Cialis, made by Eli Lilly Co. and ICOS Corp., generally
retail at pharmacies for between $13 (¤8.92) and $20 (¤13.72), while
herbals can cost less than $1 (¤.69), up to about $5 (¤3.43).
Spiked pills have turned up in Thailand, Taiwan, Canada, Australia,
New Zealand, Hong Kong, Malaysia, the United Kingdom and the United
States, according to testing done by Pfizer Inc., the New York-based
pharmaceutical giant that developed Viagra. The company said that 69
percent of 3 400 supplements it purchased in China contained sildenafil
citrate, the main ingredient in Viagra. Pfizer didn't check for the
patented ingredients of its rivals.
Under US law, because such pills are "dietary supplements," they
are far less regulated than pharmaceuticals and face few barriers to
market. Viagra, by contrast, underwent years of testing before it was
While herbal alternatives often contain exact copies of the patented
drugs, some makers tweak the molecules to keep the effect of the
original pharmaceutical while avoiding the scrutiny of the FDA and
outside testing labs.
Federal officials have only recently stepped up investigations and
prosecutions, and in any case, the FDA's recall power is limited. Last
week, in response to safety concerns about imported toothpaste, dog
food and toys, President George W. Bush recommended that the FDA be
authorised to order mandatory recalls of dangerous products.
Currently, recalls are voluntary, and even if the agency determines
that a product poses a "significant health risk," a firm may refuse to
cooperate. Plus, recalled products are widely offered on the Internet
and pills are hard to round up.
Before a product called Nasutra was recalled a year ago by its
manufacturer, the FDA had received a 30-year-old man's report of a
raging headache and an erection that wouldn't go down. Following the
recall, a 32-year-old man reported having spontaneous nose bleeds after
taking the pill, records show.
E-mails requesting comment from Nasutra LLC, the company that
voluntarily recalled the product in September 2006, were not returned.
The FDA says the firm is located in Los Angeles; there is no listed
phone number in the region.
8 recalls in last year
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. Many of the firms
were based around Los Angeles, their offices ranging from an unsigned
door in a grungy hall on the fringe of downtown to a gated complex near
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.
Company executive Michael Peng had agreed to stop selling Vigor-25
following an FDA agent's visit in late 2004, according to an arrest
warrant affidavit. But between then and his arrest in September, at
least 4.5 million pills were packaged for distribution, the affidavit
said. According to prosecutors, Peng thought he could evade tests
simply by switching from the sildenafil citrate he imported from China
to Levitra's active ingredient, vardenafil - a shipment of which US Customs intercepted from Thailand.
Levitra is marketed by Schering-Plough Corp. and GlaxoSmithKline
PLC. – (Sapa-AP)
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