Archive for the ‘Anti-impotence drugs’ Category

Viagra’s 10th anniversary

Thursday, March 27th, 2008

Viagra pillsTen years ago this month the lives of millions of men and women were changed almost overnight by the advent of a little blue pill — the first oral treatment for impotence.

Viagra, developed by accident by scientists at Pfizer Laboratories, was first approved for use by the US Food and Drug Administration on March 27, 1998.

“Originally, we were testing sildenafil, the active drug in Viagra, as a cardiovascular drug and for its ability to lower blood pressure,” said Dr Brian Klee, senior medical director at Pfizer.

“But one thing that was found during those trials is that people didn’t want to give the medication back because of the side effect of having erections that were harder, firmer and lasted longer.”

Since Viagra went on the market it has been used by 35 million men around the globe, and it took impotence off the taboo list, making it infinitely easier to treat.

Urologists’ waiting rooms became busier as news got round that the condition, which was rechristened with a new, scientific name — erectile dysfunction, or ED — could be treated with a triangular blue pill.

Previous treatments had involved surgically inserting a prosthesis into the penis, injecting a substance into the male sex organ or using urethral suppositories.

“Viagra brought a lot more people into the office because of the ease of treatment,” Dr Irwin Shuman, a urologist of 40 years’ experience in Washington, told AFP.

“In the old days, when we didn’t have much in the way of treatment, we would do a lot more evaluation, looking for answers as to why somebody had the problem,” he said.

In one test, men would be observed while sleeping to see if erections occurred.

Men who failed to get the usual five to six erections per night were deemed to have a physical problem, and those who did get nocturnal erections were said to have a psychological problem and were sent to see a sex counsellor.

So Viagra helped move impotence out of the psychological realm and into the world of physical illnesses. “What we have come to understand in the past 10 years is that ED is a vascular disease,” said Klee.

“What happens is veins and arteries that deliver and remove blood from the penis are not working the way they should, and Viagra allows those vessels to dilate and increase blood flow to the penis,” he said.

Dr Abraham Morgentaler, director of Men’s Health Boston, and associate clinical professor of urology at Harvard Medical School, hailed Viagra as a “benefit to medicine.”

But, he added, the drug has not delighted all those who took it.

“There are two truths to Viagra: for those who refill (get a new prescription), it’s wonderful and they’re happy,” Morgentaler told AFP.

“But a lot of people look to Viagra for personal happiness, thinking a hard penis can resolve relationship issues,” and they end up disappointed, added the doctor and author of the book “The Viagra Myth.”

Some patients say taking Viagra “does not correspond to the way they want to have sex,” Morgentaler said.

Viagra works best on an empty stomach or after eating a low-fat meal, the medication’s official website says. It kicks in about 30 minutes after being taken, works for four hours, and only with sexual arousal, the website says.

But it’s not the answer for everyone. Morgentaler said he had a 78-year-old patient in his office who “didn’t like the idea of programming sex. Guys, and often women, too, don’t necessarily want to compromise the ideal of sex as something magical, spontaneous, romantic.”

Morgentaler also spoke of the darker side of Viagra, which has evolved since it and two other ED treatments became easily available over the Internet.

“It’s the use of Viagra by healthy young men who don’t need it,” he said.

“These young men take a pill whenever they go out … Maybe because they are inexperienced or shy and Viagra makes them more confident, or maybe because they have inflated ideas about what sex is supposed to be like from seeing Internet porn, which they also have easy access to, and they want to heighten their feelings of masculinity,” he said.

“I am concerned — not that these young men will get addicted physically, but that they will become psychologically dependent on Viagra,” said Morgentaler.

“Sex is an entree into a relationship, and most often what we want from a relationship is to be loved for what we are.

“But some of these young men feel they have to take a pill to be acceptable, and I fear they are potentially missing the opportunity to have true emotional connections with a partner, based on reality, not mythology.”

Viagra celebrates its 10th birthday

The potency enhancing drug Viagra has been on the market for 10 years. In 1998, pharmaceutical company Pfizer introduced the erection drug that was to change millions of lives at a stroke. A solution to erectile dysfunction had been found, and the taboo surrounding impotence was largely a thing of the past.

The little blue pill that enabled millions of couples to reawaken their sex lives was discovered by accident, says sexologist Vera Steenhart of the Dutch Sexology Association. Pfizer was actually looking for a drug for the heart problem angina pectoris. The pills didn’t appear to be benefiting the test subjects, but they refused to give them back. Ms Steenhart:

“The manufacturers found this strange. On further investigation, they found the drug gave the male patients an erection. They were extremely happy about it.”

Effect
The forerunner to Viagra was developed to make blood vessels relax. The test subjects were given the drug to improve blood circulation to the heart to reduce the chance of heart failure. Viagra has the same effect on the penis. When the man is sexually stimulated, the blood supply is improved and it becomes easier for him to maintain an erection.

It’s a myth that the pill can produce an unwanted erection. The user does actually have to be in the mood, so Viagra has little or no effect if he is unwilling to have sex or feels anxious about it. In that case it would be more appropriate for him to have a good talk with his partner or pay a visit to a psychologist or sexologist.

(more…)

Daily Cialis doses: How to take these sex pills

Wednesday, January 9th, 2008

Cialis pills onlineEli Lilly and Co on Tuesday said U.S. regulators approved once-daily use of two low-dose forms of its Cialis anti-impotence drug, offering greater convenience for men expecting frequent sexual activity.

The Indianapolis drugmaker said the once-daily formulations, in dosages of 2.5 milligrams and 5 milligrams, will allow men to attempt sexual activity any time between doses.

“In clinical trials, when taken without restrictions on the timing of sexual activity, Cialis for once daily use improved erectile function over the course of therapy,” Lilly said in a release.

The low-dose daily formulations, already approved in parts of Europe, “may be most appropriate for men with erectile dysfunction who anticipate more frequent sexual activity (e.g. twice weekly),” Lilly said.

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The company said the low-dose formulations provide “a new option for men who may be looking for a dosing option that can be taken without regard to timing of sexual activity.”

The treatment, which has global annual sales of $1.2 billion, has been available in the United States since 2003 in dosages of 5 milligrams, 10 milligrams and 20 milligrams, and taken as needed. Those dosages provide effectiveness for up to 36 hours.

Company spokeswoman Keri McGrath said no dosage forms of the medicine, including the newly approved lower ones, are appropriate for heart patients who take nitrates, including nitroglycerin.

Members of the class of drugs to which Cialis belongs — including Pfizer Inc’s rival Viagra and GlaxoSmithKline Plc’s Levitra — can dangerously lower blood pressure when used alongside nitrates.

The drugs, used by millions of men worldwide, also carry new warnings about potential risk of sudden hearing loss.

Shares of Lilly were up $1.05, or 1.9 percent, to $55.60 in morning trading on the New York Stock Exchange, in line with a 2 percent advance for the drug sector.

Cialis Information

Generic Name: tadalafil

Brand Names: Cialis

What is tadalafil?

Tadalafil relaxes muscles and increases blood flow to particular areas of the body.

Tadalafil is used to treat erectile dysfunction (impotence).

Tadalafil may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about tadalafil?
Do not take tadalafil if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket). Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite (”poppers”). Taking tadalafil with a nitrate medicine can cause a serious decrease in blood pressure, leading to fainting, stroke, or heart attack. During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of tadalafil Do not take tadalafil more than once a day. Allow 24 hours to pass between doses. Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

Tadalafil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking tadalafil, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old. It is not clear whether tadalafil is the actual cause of vision loss.
Stop using tadalafil and get emergency medical help if you have sudden vision loss.

How should I take tadalafil?

Take tadalafil exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor. Follow the directions on your prescription label.
Take this medication with a full glass of water.

Tadalafil can be taken with or without food.

Tadalafil is usually taken only when needed, just before sexual activity. The medication can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. Follow your doctor’s instructions.
Do not take tadalafil more than once a day. Allow 24 hours to pass between doses. Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis. Store this medication at room temperature away from moisture and heat.

Fake Viagra and Cialis anti-impotence drugs

Wednesday, January 9th, 2008

Fake viagra pillsFrench customs officials have intercepted a shipment of 224,000 fake Viagra and Cialis anti-impotence pills worth 2.4 million euros ($3.5 million), the Budget Ministry said on Monday.

The copies of the best-selling drugs were found on December 18 during a search at the French capital’s main air hub at Roissy, in a freight cargo on its way to Brazil from India.

“Branded Powergra and Erectalis, each box contained, in fact, four tablets in the characteristic shape and color of Viagra or Cialis pills,” Budget Minister Eric Werth’s office, which is also in charge of customs, said in a statement.

“The companies Pfizer and Eli Lilly, which respectively own the Viagra and Cialis brands, quickly confirmed the counterfeit nature of these products and the 224,000 pills were seized,” Werth’s office added.

Fake Viagra maker given 10-year prison term

A man has been given a 10-year prison sentence for producing millions of fake anti-impotence pills.

Viagra, the anti-impotence drug, is made by Pfizer. [file photo]

Wang Weiping was also fined 2 million yuan (US$250,000) in a first ruling on Monday at Shaoxing Intermediate People’s Court in East China’s Zhejiang Province.

The 34-year-old, a legal worker at Kangdeli Health Care Co Ltd in Xinchang County of the province, was arrested in November last year on suspicion of producing and selling counterfeit drugs.

A total of 381,000 fake Viagra pills and 1.4 million counterfeit Cialis tablets, worth a combined total of 241 million yuan (US$29 million) on the market, were also seized from workshops at Kangdeli Health Care, according to a release from the court.

Viagra is produced by the New York-based Pfizer Pharmaceuticals, while Cialis is manufactured by Indianapolis-based Lilly Icos LLC. Both are well-known drugs to treat impotence.

Some of the fake pills were found to contain medical starch, which does not have any curative effect and others had too much sildenafil, the main ingredient of Viagra, and is detrimental to health in large doses, said the release.

Workshops to make the fake drugs were also found in Guannan County of Jiangsu Province, Zhejiang’s neighbouring province.

All counterfeit pills, production machines and materials to make the fake drugs were confiscated.

Wang began making the fake pills in Shaoxing in April last year, and established another manufacturing base at Guannan in Jiangsu Province in June.

Local police and drug administration officials uncovered the case during a crackdown on the production of fake pills.

No counterfeit drugs have actually been found in the marketplace, said Zhang Guojing, director of the Shaoxing Food and Drug Administration.

Wang’s operation is the biggest, in terms of the financial worth of the pills, to have been uncovered in Zhejiang Province.

Erectile dysfunction drugs such as Viagra and Cialis were approved by the Ministry of Health and State Food and Drug Administration as prescription drugs in 1999.

In December last year, seven people in Zhengzhou in Central China’s Henan Province were accused of selling 9.7 million fake tablets of Viagra.

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Police bust online Viagra gang

The leader of a gang selling fake Viagra over the internet has been given a four and a half year jail sentence.

Ashish Halai, 33, ordered fake Viagra tablets from suppliers in China and Mexico for 25p each and sold them for as much as ?20 online to people in the US and Europe who were too embarrassed to go to their doctor.

Three other members of the gang were also found guilty and will be sentenced later.

The case came to light after an investigation by the Medicines and Healthcare products Regulatory Agency (MHRA), which estimated that the gang netted at least ?2m from the scam.

Mick Deats, head of enforcement at the MHRA, said: “The MHRA treats every report of a counterfeit medicine as a serious incident. This successful prosecution should serve as a clear signal to those contemplating the supply of counterfeit medicines.

“The public are strongly advised to avoid buying medicines online, where the risk of being provided with counterfeit medicines is greatly increased.”

Halai is a chemist who sold his practice in Bayswater, London but continued to use the name to sell herbal supplements.

The court heard that Halai began selling fake anti-impotence drugs in 2002 passing them off as Viagra and Cialis. He packaged the drugs so skilfully that experts said it would take a trained eye to spot the difference.

Police seized over ?1.5m worth of the fake drugs when they swooped on the gang. The drugs were imported using business courier services and were disguised as pet supplements.

Viagra, Levitra, Cialis linked to hearing loss

Tuesday, October 23rd, 2007

ViagraThe US Food and Drug Administration has decided to put more prominent warnings of potential hearing loss on impotence drugs Viagra, Cialis and Levitra.

An FDA statement said the goal was “to display more prominently the potential risk of sudden hearing loss, and to guide consumers on what to do if they experience sudden problems with their hearing.”

Revatio, used to treat pulmonary hypertension, also will get the same labelling changes, the FDA said.

The warnings followed what the administration called “a very small number” of patients reporting hearing loss and at times ringing in the ears and dizziness.

“Because some level of hearing loss is usually associated with the aging process, patients on these drugs may not think to talk to their doctor about it,” said Janet Woodcock, MD, FDA deputy commissioner for scientific and medical programs, chief medical officer, and acting director of its Center for Drug Evaluation and Research.

Anti-impotence drugs linked to hearing loss

The U.S. Food and Drug Administration has approved labelling changes for three kinds of erectile dysfunction drugs to display more prominently the potential risk of sudden hearing loss.

The FDA on Thursday asked manufacturers of Viagra, Cialis and Levitra to revise product labelling after a very small number of patients taking the drugs reported sudden hearing loss, sometimes accompanied by ringing in the ears and dizziness.

It’s not clear if the drugs actually trigger hearing loss, but the agency decided to act after counting 29 reports of hearing problems since 1996 among users.

Dr. Robert Boucher, an agency ear, nose and throat specialist, said in reviewing the reports he noticed that the hearing loss occurred within 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 involved hearing loss in one ear, which in a third of cases was temporary.

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

Because some level of hearing loss is usually associated with the aging process, patients taking these drugs (phosphodiesterase type 5 inhibitors) may not think to talk to their doctor about it, said Dr. Janet Woodcock, the FDA’s chief medical officer.

Herbals for erectile dysfunction - be warned!

Monday, October 15th, 2007

herbal-remediesResearchers have warned about “herbal remedies” for erectile dysfunction sold over-the-counter in Hong Kong after most of them were found to contain untested variants of well-known anti-impotence drugs.

These variants, or “analogues,” are copies of controlled drugs but they are slightly modified in their chemical structure to escape patent and other drug-related laws.

Cranked out illegally, these chemicals are not tested for their efficacy or safety and can have unpredictable, adverse effects. They are added undeclared into “health products,” which do not come under stringent tests in most countries.

Writing in the latest issue of the Hong Kong Medical Journal, the scientists said they studied 26 anti-impotence products sold in convenience stores and pharmacies.

Although their packaging declared that they contained only “herbal ingredients,” variants of sildenafil and vardenafil were found in 14 of them. Sildenafil was found in one product.

Sildenafil and vardenafil are generic names for their better known trade labels Viagra and Levitra, respectively, and they are prescribed drugs in Hong Kong.

“The positive rate of concealed drug analogues in male erectile dysfunction health products is alarmingly high. Such analogues are difficult to detect by ordinary laboratory methods and might be used in an attempt to evade regulatory inspection,” wrote the researchers at the Hospital Authority Toxicology Reference Laboratory in the journal’s October issue.

“Without going through the stringent drug testing process, the adverse effects of these chemicals remain largely unknown and unpredictable,” they warned, as they called for urgent and more effective surveillance and control.

“The medical profession and the public should be alerted to this under-recognized threat.”

This malpractice came to light when a previously healthy 28-year-old man got admitted to hospital for an unsteady gait and frequent falls — signs of ataxia.

Doctors then learnt that he had taken an anti-impotence “health product” for over a week before showing those symptoms.

Classified as phosphodiesterase-5 inhibitors, sildenafil and vardenafil are known to have side-effects like nausea, headache, facial flushing and visual disturbances. Serious cardiovascular effects have also been reported.

But ataxia has never been linked to this class of drugs.

“Unlike the parent pharmaceutical, no formal studies have been performed to assure the safety and efficacy of these analogues,” the researchers wrote.

“Evidently, the adverse effects of drug analogues are highly unpredictable and the consumption of such products is dangerous.”

Analogues have also been found in so called “natural” or “herbal” slimming products in Hong Kong and at least one woman has died of a cardiac arrest after consuming them.

What are herbal remedies in short:

Herbal medicine, sometimes referred to as Herbalism, Botanical medicine or Herbology, is the use of plants, in a wide variety of forms, for their therapeutic value. Herb plants produce and contain a variety of chemical compounds that act upon the body and are used to prevent or treat disease or promote health and well-being.

A brief history of herbal medicine.

Humans, and even Neanderthals, have used plants to treat their ailments for at least tens of thousands of years; most likely even longer than that.

The first written accounts of the use of herbs originate in China, although all other civilisations from the ancient world were using plants as natural remedies for their ailments. Western herbal medicine dates back to ancient Greece and its famous doctors like Hippocrates and Galen.

The 15th to 17th centuries were the most popular time for herbalism in Europe. Herbal remedies are still relatively popular today, mainly due to the fact that they are regarded as harmless because they are natural.

The theory of how they work.

As herbal treatments have been around for so long, and in so many cultures, there are numerous ways that they are believed to work. Many explanations lie in the mystical thinking of ancient cultures. Some believe that the appearance of the plant gives an indication of what it can be used to treat; this physical resemblance between the plant and the body part to be cured is known as the “‘Doctrine of Signatures”; a heart shaped plant would be used to treat heart problems, for example.

From the middle ages on, many practitioners have tried to classify herbal remedies by observation of their effects. This is closer to the modern scientific approach of gathering evidence.

Eastern herbal medicine still adheres to the mystical approach in its theories whilst western herbalists tend to use herbs for the ingredients they contain; mixing and matching them in the way that conventional medicine does with modern drugs.

The three main branches of herbal medicine are:
The Western herbal tradition based on Greek, Roman and medieval sources;
The Ayurvedic tradition of India;
Chinese herbal medicine.

Remedies are produced by either taking the whole plant, or just the part of the plant required, and often mixing it with other plants. They are usually boiled in water or alcohol, and made into: herbal teas; herbal decoctions; herbal syrup; herbal tincture; infused oils; salves & ointment/creams.

Scientific evidence and herbal medicine

There is a lot of mysticism behind it. The approach involves: “balancing” the body’s vital energy; the belief that it can treat anything; it is holistic, which is the reason given why no two practitioners will prescribe the same treatment for exactly the same condition in the same person; and they insist that it is natural and therefore safe.

There is no doubt that herbs contain chemical compounds, often many thousands, many of which have a physiological effect on the body. In fact up to 25% of modern medicines are based on plant origins: Aspirin; Quinine; and Digitalis, for example, are well known.

A substance that has a physiological effect on the body is by definition: a drug. Therefore those herbal remedies that have an effect, do so because of the drugs that they contain; and drugs can be beneficial or harmful. Although some very useful drugs are obtained from plant sources, it should be noted that some of the most deadly poisons are also obtained from plants: the alkaloid poisons for example.

There is some scientific evidence to support some herbal remedies. The evidence is not strongly in favour of the remedies that do show up positive results, although it does show up the need for more quality research.