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Hot off the press:
Impotence Drug Makers Add Amnesia As Potential Side Effect
Fri Aug 22 15:48:50 2008
August 22, 2008: 02:47 PM EST
While a certain effect of erectile-dysfunction drugs may last more than four hours, the memories may not last so long.
U.S. drug regulators recently approved revisions to the prescribing labels for three anti-impotence drugs to reflect reports of sudden, temporary memory loss in users. The rare condition is called "transient global amnesia."
The Food and Drug Administration approved the label revisions earlier this month for Pfizer Inc.'s (PFE) Viagra and Eli Lilly & Co.'s (LLY) Cialis. In May, the FDA approved a similar label revision for Bayer AG's (BAYRY) Levitra, which is co-promoted in the U.S. by GlaxoSmithKline PLC (GSK) and Schering-Plough Corp. (SGP).
The drug makers say the number of cases has been limited, but they're adding transient global amnesia to the lists of post-marketing adverse reactions in the drugs' prescribing labels. Such label changes usually mean that multiple users have reported health problems after taking a drug, but the reports don't necessarily mean that the drug caused the problem.
Indeed, it's not clear whether the drugs are causing the memory loss, or if other factors are to blame. Transient global amnesia can occur in people who haven't taken ED drugs, and the underlying cause is unknown, according to the Mayo Clinic's Web site.
New York-based Pfizer said there's no evidence that Viagra causes the condition. Some doctors, however, have suggested there may be a link between the drugs and amnesia.
"We ... routinely conduct reviews of both clinical and post-marketing safety surveillance data," Pfizer spokeswoman Sally Beatty said in a written statement. "To date, the data do not suggest a causal relationship between the use of Viagra and transient global amnesia."
Lilly spokeswoman Keri McGrath said transient global amnesia was rare in Cialis users. She added that the Indianapolis company monitors safety data for Cialis and regularly provides adverse-event reports to regulatory bodies globally.
Rob Perry, spokesman for the U.K.'s GlaxoSmithKline, said no causal relationship had been established, and there were a "very limited" number of cases of amnesia in Levitra users.
Pfizer said increased age and sexual activity are risk factors for transient global amnesia. Commonly reported events that can trigger the condition also include sudden immersion in cold or hot water, strenuous physical activity, medical procedures such as endoscopy and acute emotional distress, according to the Mayo Clinic.
Transient global amnesia is temporary memory loss that can't be attributed to more common neurological conditions such as head injury or epilepsy. The memory loss episodes typically last about six hours. People who experience it lose their recall of events and can't remember where they are or how they got there, the Mayo Clinic said.
Christopher Saigal, assistant professor of urology at UCLA's medical school, said he's never had a patient report transient global amnesia "and I've had a ton of patients" on the ED drugs. He has been practicing since the 1990s.
Still, this isn't the first time ED drugs have been linked to amnesia. A 2005 article in the International Journal of Impotence Research described the case of a 46-year-old man who was brought to the emergency room because he had couldn't remember any events since waking up in the morning or the night before, including sexual intercourse after taking Cialis. His memory gradually improved and tests for cardiovascular and brain problems came back normal.
The German neurologists who wrote the 2005 article said there had been 35 reports of amnesia in Viagra users between 1998 and 2001. They suggested there may be a causal link between the drugs and transient global amnesia, though they couldn't rule out that other factors may have caused the condition.
Other health problems have previously been tied to ED drugs. Men taking nitrates for chest pain aren't supposed to take ED drugs because the combination can cause a sudden, unsafe drop in blood pressure. Also, some men taking ED drugs have reported a sudden decrease or loss of vision or hearing, though it's not known if these events are directly related to the drugs. And as any regular viewer of TV commercials can tell you, prolonged erections lasting more than four hours also have been reported, which requires immediate medical help to avoid long-term injury.........
-By Peter Loftus, Dow Jones Newswires; 215-656-8289; peter.loftus@dowjones.com
(Jared Favole and Dinah Wisenberg Brin contributed to this article.)
http://money.cnn.com/news/newsfeeds/articles/djf500/200808221447DOWJONESDJONLINE000692_FORTUNE5.htm
Herbal sex pills pose hidden dangers
Fri Aug 22 15:54:16 2008
Herbal Sex-boost Pills May Be Unsafe
LOS ANGELES (AP) -- 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 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 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.
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 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 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 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.
By JUSTIN PRITCHARD
Associated Press Writer
If Sex Drugs Fail, Men Still Have Plenty of Options
Fri Aug 22 15:54:48 2008
Insert BodyFor many men with erectile function problems, Viagra and similar pills are nothing short of wonder drugs. But the untold story of the sex drug business is that the treatments simply don't work for a large percentage of men.
How to help men who aren't helped by sex drugs is an area of growing concern in the medical community. Clearly the drugs Viagra, Cialis and Levitra -- a class of drugs called PDE-5 inhibitors -- have revolutionized the treatment of erectile dysfunction. But consider this: Fewer than 50% of the men who try them ever bother to get a refill.
Part of the problem is that while the drugs can be highly effective for some men, they don't work nearly as well in men with diabetes or severe cardiovascular disease, or those who have been treated for prostate cancer. Studies show that the pills don't work at all in about 30% of men who try them. Up to 20% of men stop using the pills because they can't tolerate side effects, which can include runny nose, headache and backache, depending on the brand of pill they use.
"When they work, they're great," says Drogo K. Montague, head of prosthetic surgery at the Cleveland Clinic's Urologic Institute. "But they don't always work. A lot of men don't know they have other options."
The First Step
Indeed, men have far more options than they think. The first step for a man who isn't helped by a sex drug is to go back and talk to his doctor. Sometimes the problem is that he isn't using it correctly, expecting it to work too soon or without sexual stimulation. Although Viagra, Levitra and Cialis are similar in the way they work in the body, they can have different effects in different men, so some patients benefit from switching brands.
"There's not one best drug for everybody," says Andrew McCullough, director of male sexual health and fertility at New York University School of Medicine. "But there is probably a better drug for each individual. You just have to find out what it is."
Men who aren't helped by oral treatments for erectile dysfunction need to be open to the alternatives. None of them are as easy as taking a pill, and the descriptions may make some men queasy. But men who use them say they aren't nearly as unpleasant as they sound, and the benefit -- consistently successful erections and a rejuvenated sex life -- makes them well worth the effort. Insurance coverage for the different erectile-dysfunction treatments varies, but if a man's policy covers the pills, it's likely to cover the other options as well.
Common Alternatives
One common treatment is called MUSE, which stands for medicated urethral suppository for erection. To use it, a man inserts a small applicator into his urethra (at the tip of the penis) releasing a small pellet that contains the drug alprostadil, which is similar to a naturally occurring chemical produced by the prostate. An erection develops in five to 10 minutes and generally lasts for 30 minutes to an hour. Some men get even better results when they take both an oral drug like Viagra at the same time they use the MUSE suppository. About one-third of men might experience a burning sensation from the drug, but the problem typically isn't bad enough to cause men to stop using it. The downside: Inserting the device requires basic hand-eye coordination, and men with poor vision or who are severely overweight often find it difficult to administer. MUSE costs about $25 a dose.
A more-effective option is to inject alprostadil or similar-acting drugs directly into the base of the penis. Although the thought of an injection makes many men squirm, the base of the penis is the least sensitive area, and men typically don't feel pain when they use this option. Penile injections are especially effective for men who have been treated for prostate cancer.
The downside is that many men tire of the injections; over time, as many as 80% stop using them. The injections can cost up to $25 a dose, depending on whether a branded drug or generic is used.
One surprising option is a vacuum constriction device. It uses a cylinder and pump device that causes the penis to engorge with blood, creating an erection. Studies show the pump is between 66% and 83% effective. Some men don't find it comfortable, and the device poses obvious limits to spontaneity. But for men who don't mind those limitations, the device has a high satisfaction rate, particularly among men in stable relationships. The vacuum device doesn't require a prescription and costs $150 to $450.
Surgical Help
For men who aren't helped by any of the less-invasive treatments, a penile implant might be an option. Implants can be semi-rigid rods or a saline-filled device that can be pumped up. The surgery has success rates of 85% to 90% and, unlike other treatments, is highly effective regardless of the underlying cause of erectile dysfunction. Like all surgery, the implant procedure carries a risk of infection or other complications. The cost of the device, surgery and hospitalization totals around $20,000.
Doctors say the biggest problem with pill alternatives is a general lack of awareness as well as a perception by some physicians that men won't accept treatments like injections or a pump.
"It's all in how it's presented," says Dr. McCullough. "My approach is not to say, 'You have an option of sticking a tube in your penis, or using a needle or vacuum device or implant.' My approach is to say, 'Today you're going to have your first erection in what may be months or years.' It's not about the process, it's about the end goal."
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