Herbal Sex Pills Pose Hidden Dangers

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.

BY Mike Grippi

November 13 2007 1:00 AM ET

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 hotlines 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 -- who are generally older and more likely to need
help with erectile dysfunction.

The all-natural
message can be appealing to such men who have been 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% 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 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 the stroke.

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% 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, 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 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.

Pills like Cialis
generally retail at pharmacies for between $13 and $20,
while herbals can cost less than $1, up to about $5.

Many health
insurance plans provide limited coverage for prescription
sex pills, especially for those with health-related
difficulties. Few over-the-counter treatments are
covered, and herbals aren't likely to be among them,
in part because they're classified as foods, not
pharmaceuticals, said Mohit M. Ghose, spokesman for
America's Health Insurance Plans, which represents
major health insurers.

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,
the New York City–based pharmaceutical giant
that developed Viagra. The company said that 69% 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 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 was publicly available.

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 Bush recommended that the FDA be authorized 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.

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 Beverly Hills.

One recall
involved a pill called Liviro3.

The current owner
of the drug's marketing and distributing firm said that
after he tried the product, he quit his job at a car
dealership and bought the brand name and stock of
several thousand pills in 2004 for $450,000. In
January, he said, FDA agents seized his stockpile after an
agency 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.

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 U.S. Customs
intercepted from Thailand.

Peng, who said
through his attorney that he was ''unaware that there was
anything other than natural supplements'' in Vigor-25, faces
a charge of misbranding -- in this instance, claiming
that a pharmaceutical is a dietary supplement.

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. Prosecutors tried to keep Wheat
from posting bail by asserting that he contemplated
killing an FDA investigator and bribing a prosecutor.

Fulmer rejected
those assertions, which did not lead to charges, saying
Wheat is hardworking and nonviolent. Fulmer said Wheat's two
businesses are legitimate and continue to be
successful.

Wheat was granted
bond after pledging approximately $7.5 million in cash
and property; he's free under home confinement. (AP)

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