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 very anxiety cialis soft treatment viagra
s 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 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 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 Erectile dysfunction pill
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.

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.

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 tadalafil soft tab
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 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 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 dysfunction erectile male sexual 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.

___

Associated Press researcher Julie Reed in New York and Associated Press writer Andrew Bridges in Washington contributed to this report.

WASHINGTON - Viagra and other impotence drugs are about to bear new warnings that users may experience sudden hearing loss.

It’s not clear that the drugs truly trigger hearing loss, but the Food and Drug Administration decided Thursday to add a warning about the possible risk after counting 29 reports of the problem since 1996 among users of this family of medicines.

The impotence drugs Viagra, Cialis and Levitra will bear the warnings. So will Revatio, a drug for pulmonary tadalafil cialis from india, which contains the same ingredient as Viagra.

Viagra’s label already mentioned hearing loss as a possibility, because a few cases were reported during initial testing of that drug. But given that hearing loss is a risk of advancing age and certain buy discount cialis
, such as diabetes and heart disease, that can lead to impotence, it wasn’t clear if the link was real.

That still isn’t clear, said FDA ear nose and throat specialist Dr. Robert Boucher.

But in poring over FDA’s database of possible drug reactions, what struck him was these 29 reports said the hearing loss occurred without hours to two days of taking one of the drugs.

“We don’t know enough to say that it’s ironclad caused by the drugs, but we see enough to say we can’t ignore it either,” he said.

The reports involve hearing loss in one ear, which in a third of cases was generic cialis tadalafil price comparison
.

FDA urged patients who experience any hearing problems — loss or ringing in the ears — to promptly call their doctors and stop taking the impotence drugs.

Here are some of the latest health and medical news developments,
compiled by editors of HealthDay:

Impotence Drugs to Carry Hearing Loss
Warnings

New warnings about the potential risk of sudden hearing loss will be
added to the labels of Viagra and other drugs to treat erectile
dysfunction, the U.S. Food and Drug Tadalafil for sale
says.

While it's not clear whether the drugs actually do cause hearing loss,
the FDA said that since 1996 there have been 29 reports of hearing
problems among users of these kinds of drugs, the Associated Press
reported.

The new warnings will be carried by the impotence drugs Viagra, Cialis
and Levitra, as well as the pulmonary hypertension drug Revatio, which
contains the same ingredient as Viagra.

In the 29 reports noted by the FDA, hearing loss occurred within hours
to two days after patients took one of the drugs, said FDA ear-and-nose
specialist Dr. Robert Boucher.

“We don't know enough to say that it's ironclad caused by the drugs,
but we see enough to say we can't ignore it either,” he told the
AP.

People who take the drugs and experience hearing loss or ringing in the
ears should stop the medications and contact their doctor, the FDA
said.

—–

San Francisco May Consider Tadalafil cialis

Site

In what may turn out to be the first step toward opening a
safe-injection site, San Francisco officials co-sponsored a symposium
Thursday on a facility in Vancouver, British Columbia, the only such
program in North America, the Associated Press reported.

At the Vancouver site, about 700 intravenous drug users shoot up
heroin, cocaine and other narcotics under the supervision of nurses. San
Francisco health officials may consider a safe-injection site as a way to
reduce the city's high rate of fatal drug overdoses.

“Having the conversation today will help us figure out whether this is
a way to reduce the harms and improve the health of our community,” said
Grant Colfax, director of HIV prevention for the San Francisco Department
of Health, the AP reported.

However, a federal official said the city's consideration of a
safe-injection site was “terapia tadalafil
” and “poor public policy.”

“The underlying philosophy is, 'We accept drug addiction, we accept the
state of affairs as acceptable. This is a form of giving up,” Bertha
Madras, deputy director of demand reduction for the White House Office of
National Drug Control Policy, told the AP.

There are 65 safe-injection sites in 27 cities in eight countries. So
far, San Francisco is the only U.S. city to consider creating a legal
safe-injection site, said Hilary McQuie, Western director for the
nonprofit Harm Reduction Coalition, which promotes alternative drug
treatment methods.

—–

CDC Redesigns Spanish Web Site

The U.S. Centers for Disease Control and Prevention says it's
redesigned its Spanish Web site, CDC en Espanol, with a new look and features meant to
make it more usable and functional.

The redesigned site has a more useful and powerful search engine, quick
access to the 20 most-requested topics of information, a user-friendly A-Z
index, and other features that will make it easier for people to find the
health and science information they seek, the CDC said.

The site, which provides information in Spanish on health issues of
special interest to Hispanic communities, has more than six million
visitors a year and its weekly distribution list includes almost 6,000
members in more than 40 countries.

—–

Sunlight May Decrease Risk of Advanced Breast
Cancer

Exposure to sunlight — which boosts levels of vitamin D in the body –
may reduce the risk of advanced breast cancer, according to a U.S. study
published online this week in the American Journal of
Epidemiology.

The study of 1,788 breast cancer patients and 2,129 women who didn't
have the disease found that women with high sun exposure had half the risk
of developing advanced breast cancer than women with low sun exposure.
However, this effect was noted only in women with naturally light skin
color.

“We believe that sunlight helps to reduce women's risk of breast cancer
because the body manufactures the active form of vitamin D from exposure
to sunlight,” lead researcher Esther John, of the Northern California
Cancer Center, said in a statement. “It is possible that these effects
were observed only among light-skinned women because sun exposure produces
less vitamin D among women with naturally darker pigmentation.”

John and her colleagues emphasized that women should not sunbathe in an
attempt to reduce their breast cancer risk.

“If future studies continue to show reductions in breast cancer risk
associated with sun exposure, increasing vitamin D intake from diet and
supplements may be the safest solution to achieve adequate levels of
vitamin D,” co-researcher Gary Schwartz, of the Comprehensive Cancer
Center at Wake Forest University School of Medicine, said in a
statement.

—–

Bad Habits Increase Osteoporosis
Risk

Smoking, excess alcohol consumption, being underweight, lack of
exercise, and poor nutrition are factors that could increase the risk of
osteoporosis later in life, says an Sale tadalafil
Osteoporosis Foundation
(IOF) report released to mark World Osteoporosis Day on Oct. 20.

Osteoporosis risk factors fall into two main categories, modifiable and
fixed. People can't control fixed risk factors — such as age, gender, and
family history — but they can do things that may lessen their
effects.

Following a bone-healthy lifestyle — including eating a nutritious
diet, getting regular exercise, and avoiding smoking and excess alcohol
consumption — can help build strong bones and prevent fractures, the IOF
said.

By 2050, it's estimated that the incidence of hip fracture (a major
consequence of osteoporosis) will increase by 310 percent in men and 240
percent in women, according to IOF Chief Executive Officer Daniel
Navid.

Report author and IOF board member Professor Cyrus Cooper said if
“people recognize osteoporosis risk factors when they are young and take
appropriate action, it can have enormous positive impact on their bone
health in later years.”

—–

Millions of American Teens Smoke, Drink, Use
Drugs Each Day: Report

On an average day in 2006, 1.2 million American teens smoked
cigarettes, 631,000 drank, 586,000 used marijuana, almost 50,000 used
inhalants, 27,000 used hallucinogens, 13,000 used cocaine, and 3,800 used
heroin, according to a government report released Thursday.

It also found that on an average day, almost 8,000 adolescents ages 12
to 17 drank alcohol for the first time, about 4,300 used an illicit drug
for the first time, about 4,000 smoked cigarettes for the first time,
almost 3,600 used marijuana for the first time, and about 2,500 abused
pain reliever for the first time.

The report, by the U.S. Substance Abuse and Mental Health Services
Administration (SAMHSA), is based on national surveys conducted and
analyzed by the agency's Office of Applied Studies.

“While other studies have shown that significant progress has been made
in lowering the levels of substance abuse among young people in the last
few years, this report shows many young people are still engaging in risky
behavior,” SAMHSA Erectile dysfunction tabs
Terry Cline said in a prepared
statement.

“By breaking the data down and analyzing on a day-to-day basis, we gain
fresh perspective on how deeply substance abuse pervades the lives of many
young people and their families,” Cline said.