Tag Archives: viagra

New drug approved for erectile dysfunction

Posted on April 30, 2012 by | 1 Comment

 

FDA NEWS RELEASE

For Immediate Release: April 27, 2012
Media Inquiries: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves Stendra for erectile dysfunction

The U.S. Food and Drug Administration today approved Stendra (avanafil), a new drug to treat erectile dysfunction.

Erectile dysfunction is when a man has trouble getting or keeping an erection. An estimated 30 million men in the United States are affected by erectile dysfunction.

Stendra is a pill that patients take on an as-needed basis 30 minutes before sexual activity. Doctors should prescribe the lowest dose of Stendra that provides benefit.

“This approval expands the available treatment options to men experiencing erectile dysfunction, and enables patients, in consultation with their doctor, to choose the most appropriate treatment for their needs,” said Victoria Kusiak, M.D., deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research.

Stendra belongs to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors, which are used to help increase blood flow to the penis. As with other PDE5 inhibitors, Stendra should not be used by men who also take nitrates, commonly used to treat chest pain (angina), because the combination can cause a sudden drop in blood pressure.

PDE5 inhibitors may rarely cause color vision changes. In rare instances, men taking PDE5 inhibitors have reported a sudden loss of vision in one or both eyes. Sudden loss or decrease in hearing has also been reported in patients taking PDE5 inhibitors. Patients who experience a sudden loss of vision or hearing should stop taking PDE5 inhibitors, including Stendra, and call a doctor right away.

The most common side effects reported in greater than 2 percent of patients in the clinical studies of Stendra include headache, redness of the face and other areas (flushing), nasal congestion, common cold-like symptoms (nasopharyngitis), and back pain. In rare cases, patients taking Stendra and other PDE5 inhibitors may get an erection lasting four hours or longer that will not go away (priapism). If this happens, patients should seek immediate medical care.

Stendra’s safety and efficacy were established in three double-blind, placebo-controlled clinical studies. A total of 1,267 patients were randomly assigned to take Stendra for up to 12 weeks at doses of 50 milligrams (mg), 100 mg or 200 mg, or a placebo as needed about 30 minutes before sexual activity.

At the start of the studies and every four weeks thereafter, patients completed questionnaires to evaluate erectile function, vaginal penetration and successful intercourse. Results showed patients taking Stendra experienced statistically significant improvement in all three endpoints for all three doses of Stendra studied.

To further evaluate Stendra’s safety, a subset of patients from two of the studies were enrolled in another trial to receive up to an additional 40 weeks of treatment. Patients were initially given Stendra at the 100 mg dose, but could have their dose increased to 200 mg or decreased to 50 mg based on their individual response to treatment. Results showed that the side effects commonly reported in patients using Stendra did not worsen over time.

Stendra is marketed by Mountain View, Calif.-based VIVUS Inc.

For more information:

FDA Approved Drugs: Questions and Answers

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

#

Read our Blog: FDA Voice
Visit the FDA on Facebookdisclaimer icon, Flickrdisclaimer icon, YouTubedisclaimer icon and Twitterdisclaimer icon
RSS Feed for FDA News Releases
-

→ 1 Comment

Posted in Drugs

Tagged , ,

Scientists: Watermelon yields Viagra-like effects

Posted on July 2, 2008 by | Leave a comment

By BETSY BLANEY, Associated Press Writer

A slice of cool, fresh watermelon is a juicy way to top off a Fourth of July cookout and one that researchers say has effects similar to Viagra — but don’t necessarily expect it to keep the fireworks all night long.

Watermelons contain an ingredient called citrulline that can trigger production of a compound that helps relax the body’s blood vessels, similar to what happens when a man takes Viagra, said scientists in Texas, one of the nation’s top producers of the seedless variety.

Found in the flesh and rind of watermelons, citrulline reacts with the body’s enzymes when consumed in large quantities and is changed into arginine, an amino acid that benefits the heart and the circulatory and immune systems.

“Arginine boosts nitric oxide, which relaxes blood vessels, the same basic effect that Viagra has, to treat erectile dysfunction and maybe even prevent it,” said Bhimu Patil, a researcher and director of Texas A&M’s Fruit and Vegetable Improvement Center. “Watermelon may not be as organ-specific as Viagra, but it’s a great way to relax blood vessels without any drug side effects.”

Todd Wehner, who studies watermelon breeding at North Carolina State University, said anyone taking Viagra shouldn’t expect the same result from watermelon.

“It sounds like it would be an effect that would be interesting but not a substitute for any medical treatment,” Wehner said.

The nitric oxide can also help with angina, high blood pressure and other cardiovascular problems, according to the study, which was paid for by the U.S. Department of Agriculture.

More citrulline — about 60 percent — is found in watermelon rind than in the flesh, Patil said, but that can vary. But scientists may be able to find ways to boost the concentrations in the flesh, he said.

Citrulline is found in all colors of watermelon and is highest in the yellow-fleshed types, said Penelope Perkins-Veazie, a USDA researcher in Lane, Okla.

She said Patil’s research is valid, but with a caveat: One would need to eat about six cups of watermelon to get enough citrulline to boost the body’s arginine level.

“The problem you have when you eat a lot of watermelon is you tend to run to the bathroom more,” Perkins-Veazie said.

Watermelon is a diuretic and was a homeopathic treatment for kidney patients before dialysis became widespread.

Another issue is the amount of sugar that much watermelon would spill into the bloodstream — a jolt that could cause cramping, Perkins-Veazie said.

Patil said he would like to do future studies on how to reduce the sugar content in watermelon.

The relationship between citrulline and arginine might also prove helpful to those who are obese or suffer from type-2 diabetes. The beneficial effects — among them the ability to relax blood vessels, much like Viagra does — are beginning to be revealed in research.

Citrulline is present in other curcubits, like cucumbers and cantaloupe, at very low levels, and in the milk protein casein. The highest concentrations of citrulline are found in walnut seedlings, Perkins-Veazie said.

“But they’re bitter and most people don’t want to eat them,” she said.

→ Leave a comment

Posted in Alternative, Diet and Nutrition, Drugs, Health & Fitness, Medicine, Society, Survival, Wellness

Tagged , , , , , , ,

Erectile dysfunction predicts heart problems: study

Posted on May 31, 2008 by | 7 Comments

Erectile dysfunction predicts heart problems: study

By Amy Norton

Problems with maintaining an erection may foretell heart trouble ahead for men with type 2 diabetes, two new studies show.

A number of past studies have found a connection between erectile dysfunction (ED) and heart disease. But the new findings, published in the Journal of the American College of Cardiology, confirm that ED often precedes and predicts heart trouble.

This, say researchers, suggests that men with ED should be especially vigilant about controlling heart disease risk factors.

In one study, Italian researchers found that among 291 men with type 2 diabetes, those who also had ED had twice the risk of suffering a heart attack, stroke or other cardiovascular complication over the next four years.

At the start of the study, all of the men had had evidence of “silent” heart disease — meaning they had plaque buildup in their arteries on imaging tests, but no heart disease symptoms, such as chest pain. Having ED seemed to pinpoint those men who were at particular risk of a complication.

There was some good news as well, however: Taking cholesterol-lowering statins appeared to reduce the risks associated with ED, according to the researchers, led by Dr. Carmine Gazzaruso of the Clinical Institute “Beato Matteo” in Vigevano, Italy.

In the second study, Hong Kong researchers found that among diabetic men with no indications of heart disease at the outset, those with ED were 58 percent more likely to die of heart disease, or have a heart attack or other non-fatal cardiac “event.”

“Erectile dysfunction is an important warning sign of future adverse heart events or even death,” study chief Dr. Peter Chun-Yip Tong, of the Chinese University of Hong Kong, told Reuters Health.

The main reason, he explained, is that ED is an early manifestation of the blood vessel damage caused by diabetes and other risk factors for heart disease, such as high blood pressure.

Tong recommended that all men with diabetes tell their doctor if they begin to have problems getting or maintaining an erection. They can then have a comprehensive assessment of their cardiovascular risk factors — such as measurements of their blood pressure, cholesterol, waist size and kidney function — and work on getting those under control.

Indeed, the Italian study suggests that diabetic men with ED can cut some of their heart risks by using a statin. Gazzaruso’s team found that among patients with ED, those who were on a statin had a one-third lower chance of suffering a heart attack or other complication during the study.

There was also evidence that men taking a class of ED drugs called PDE-5 inhibitors, which includes Viagra, had lower heart risks. According to the researchers, this may reflect the fact that the drugs improve the function of the inner lining of artery walls.

The bottom line, according to Tong, is that men with diabetes and ED should have all of their modifiable heart risk factors “identified early and treated aggressively.”

SOURCE: Journal of the American College of Cardiology, May 27, 2008.

→ 7 Comments

Posted in Drugs, Environment, Medicine, Society, Survival, Wellness

Tagged , , , , , , , , , , ,

Will a Cialis pill a day keep the Viagra away?

Posted on January 15, 2008 by | Leave a comment

I don’t even know what to say about this one!  One of the main side effects of Cialis, Viagra and Levitra are headaches.  For once- it will be the husband who complains of a headache. Viagra became a household name once it became clear that men with erectile dysfunction could benefit from it.  As a matter of fact,  former Presdiential candidate Bob Dole even did a commercial about it. Within years, competitor Cialis and Levitra became popular alternatives.

——-

NEW YORK (Reuters) – Eli 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.

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.

(Reporting by Ransdell Pierson, editing by Gerald E. McCormick)

→ Leave a comment

Posted in Drugs, Health & Fitness, Medicine

Tagged , , , , , , , ,

A pack per day of cigarettes = impotence in men

Posted on January 8, 2008 by | 1 Comment

Since diabetes, heart attacks and strokes don’t encourage men to quit smoking, maybe this will.  A new study  shows that men who smoke up to 1 pack per day have a 39% increased risk of impotence.  The number of cigarettes smoked per day is directly related to risk of impotence. The reason is simple. We all know that cigarettes increase clogged arteries.   However when people think of this, they generally think of only their heart.  The truth is any  organ that gets blood (all organs) is at risk for decreased blood flow.  The male penis is no exception and erectile  dysfunction is the result.   Consider Chanitx to help you quit smoking, studies have shown excellent results. If you still have trouble with ED, talk to your doctor about Viagra, Levitra or Cialis.

——

By Serena Gordon
HealthDay Reporter

SUNDAY, Dec. 30 (HealthDay News) — If heart disease, stroke and certain cancers haven’t been reason enough for men to quit smoking, consider this: The habit also increases the risk of erectile dysfunction.

In fact, emerging research shows that men with a pack-a-day habit are almost 40 percent more likely to struggle with erectile dysfunction than men who don’t smoke.

“Smoking delivers nicotine and other vasoconstrictors that close down the blood vessels” of the penis, explained Dr. Jack Mydlo, chairman of urology at Temple University School of Medicine and Hospital in Philadelphia.

Erectile dysfunction — also called “ED” or impotence — is the inability to achieve or sustain an erection on repeated occasions. It’s estimated that about two of every 100 American men have erectile dysfunction serious enough to warrant a doctor’s visit, according to the U.S. National Institute of Diabetes and Digestive and Kidney Disorders. As men age, the risk of erectile dysfunction increases.

A recent study of more than 8,000 Australian men between the ages of 16 and 59 found that those who smoked less than a pack a day had a 24 percent increased risk of erectile problems. And, as the number of cigarettes smoked went up, so, too, did the chances of erectile dysfunction. Those men who averaged more than 20 cigarettes a day increased their risk of erectile dysfunction by 39 percent, reported the study, published in the journal Tobacco Control.

Another study, this one published in the American Journal of Epidemiology, found that male smokers in their 40s were more likely to experience erectile difficulties than older nonsmoking males. The risk of erectile dysfunction was nearly doubled for smoking men in their 40s compared to nonsmokers in their 50s.

“Smoking, because it causes blood vessel constriction, is a very big cause of erectile dysfunction,” said Dr. Larry Lipshultz, chief of male reproductive medicine at Baylor College of Medicine in Houston.

Smoking isn’t the only cause of impotence problems — other lifestyle habits can have a big impact on men’s sexual health. Obesity, heavy alcohol consumption and recreational drug use can all cause erectile dysfunction. And a sedentary lifestyle can also contribute to erectile problems, Lipshultz added.

Other causes include diabetes; heart disease; cancer surgery of the prostate, bladder, colon or rectum; high blood pressure medications or antidepressants; a spinal injury; and a hormone imbalance, usually low testosterone, Lipshultz explained.

All of these conditions or lifestyle factors contribute to erectile difficulties in three major ways: By reducing blood flow, causing nerve damage, or changing the hormonal environment.

While there are medications that can help treat erectile dysfunction, both Mydlo and Lipshultz advocated a healthy lifestyle for maintaining good sexual health.

“Take better care of yourself. Make sure you’re not obese, eat well, exercise, and if you have diabetes or hypertension, make sure they’re well-controlled,” advised Lipshultz, who added that by addressing lifestyle factors, you may not need medication to treat erectile dysfunction.

Mydlo echoed that advice, adding, “Stop smoking, drink in moderation, lose weight, and maintain good blood pressure.”

Mydlo added one more word of caution: “Don’t use ED medications — Viagra, Cialis — if you don’t need them. Erections that last longer than four hours — priapism — can cause permanent scar tissue and permanent impotence. It’s not a good idea to use these drugs casually.”

More information

To learn more about erectile dysfunction and how to prevent it, visit the National Institute of Diabetes and Digestive and Kidney Diseases.

→ 1 Comment

Posted in Diseases, Drugs, Health & Fitness, Medicine

Tagged , , , , ,