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FDA Medwatch Alert: Virility Max: Recall - Undeclared Drug Ingredient

Posted 14 Nov 2011 by Drugs.com

ISSUE: FDA lab analysis for Lot 10090571 found Virility Max to contain sulfoaildenafil, an analog of sildenafil. Sildenafil is an active ingredient of an FDA approved drug for erectile dysfunction (ED), making Virility Max an unapproved drug. The active drug ingredient is not listed on the product label. The undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing. BACKGROUND: Virility Max is marketed for sexual enhancement. It is distributed in 10 count, white plastic bottles to retail customers in the South Florida area. RECOMMENDATION: Consumers who have this product in their possession should stop use ... Read more

Related support groups: Erectile Dysfunction

FDA OKs Impotence Drug Cialis to Treat Enlarged Prostate

Posted 7 Oct 2011 by Drugs.com

THURSDAY, Oct. 6 – The U.S. Food and Drug Administration announced late Thursday that it had approved using the erectile dysfunction drug Cialis as a treatment for enlarged prostate. According to the U.S. National Institutes of Health, enlarged prostate – clinically known as benign prostatic hyperplasia (BPH) – is a "common part of aging" for men. In fact, the NIH estimates that "more than half of men in their 60s, and as many as 90 percent in their 70s and 80s, have some symptoms of BPH." The condition often leads to urinary incontinence and can raise the odds for urinary tract infections and even kidney damage. "BPH can have a big impact on a patient's quality of life," Scott Monroe, director of the division of reproductive and urologic products in the FDA's Center for Drug Evaluation and Research, said in an agency news release. "A large number of older men have symptoms of BPH. ... Read more

Related support groups: Erectile Dysfunction, Cialis, Flomax, Benign Prostatic Hyperplasia (BPH), Avodart, Urinary Incontinence, Cardura, Rapaflo, Jalyn, Hytrin, Proscar, Uroxatral

New Test Predicts Risk for Impotence After Prostate Cancer Therapy

Posted 20 Sep 2011 by Drugs.com

TUESDAY, Sept. 20 – Researchers say they've developed a method that reasonably predicts which men undergoing prostate cancer treatment will suffer from impotence as a result. The strategy could someday be one more ingredient in the decision-making process for men faced with the choice of whether to undergo certain prostate cancer therapies or simply "wait and see" if the tumor becomes aggressive. "With cancer in general the most important goal is to prolong life and ensure survival," explained study senior author Dr. Martin G. Sanda, director of the prostate center at Beth Israel Deaconess Medical Center in Boston, as well as an associate professor of urology at Harvard Medical School. "But with early-stage prostate cancer most men do survive." The question then shifts, he said, to doing a better job predicting the kind of side effects each individual is likely to suffer from treatment ... Read more

Related support groups: Erectile Dysfunction, Prostate Cancer

Erectile Dysfunction May Be Linked With Cardiovascular Trouble

Posted 14 Sep 2011 by Drugs.com

WEDNESDAY, Sept. 14 – Men who suffer from erectile dysfunction are at increased risk for cardiovascular disease, stroke and death, Chinese researchers suggest. Although it is well accepted that cardiovascular disease is a risk factor for erectile dysfunction, it has not been clear whether erectile dysfunction is an independent risk factor for cardiovascular disease, the researchers noted. "Erectile dysfunction significantly increased the risk of cardiovascular disease, and the increase was probably independent of conventional risk factors," said lead researcher Dr. Li-Qiang Qin, from the department of nutrition and food hygiene in the School of Public Health at Soochow University in Suzhou. As such, "erectile dysfunction may not only contribute to cardiovascular risk prediction, but also serve as a potential target for cardiovascular disease prevention," Qin said. The report was ... Read more

Related support groups: Heart Disease, Erectile Dysfunction, Ischemic Stroke, Prevention of Cardiovascular Disease

Protecting Heart May Improve Erectile Dysfunction

Posted 13 Sep 2011 by Drugs.com

TUESDAY, Sept. 13 – The lifestyle changes and medications used to reduce risk factors for heart disease may also improve sexual function in men with erectile dysfunction, according to a new study. Researchers from the Mayo Clinic in Rochester, Minn., analyzed six previous studies from four countries involving 740 men to determine how lifestyle changes and drugs used to treat risk factors for heart disease affected the severity of their erectile dysfunction (ED). Each study reviewed reported improvements in men's erectile dysfunction as a result of lifestyle changes and better blood lipid levels. Heart disease and ED share certain controllable risk factors, such as high blood pressure, smoking, obesity and lack of physical activity, the researchers explained. Moreover, erectile dysfunction appears to be an indicator of heart disease, the researchers said. "Men with ED provide an ... Read more

Related support groups: Erectile Dysfunction, Prevention of Cardiovascular Disease

An Older Man's Sex Life May Suffer When She's Close to His Friends

Posted 9 Aug 2011 by Drugs.com

TUESDAY, Aug. 9 – When an older man's wife or girlfriend has a stronger bond with his friends than he does, his performance in the bedroom tends to suffer, a new study shows. In fact, the researchers found that men who find themselves in this situation "are more likely to have trouble getting or maintaining an erection and are also more likely to experience difficulty achieving orgasm during sex," compared to couples where there's a clearer line between his friends and hers, wrote study authors Benjamin Cornwell, a professor of sociology at Cornell University, and Edward Laumann, a professor of sociology at the University of Chicago. In the study, published online Aug. 8 in the American Journal of Sociology, the researchers analyzed a national survey of more than 3,000 people ranging in age from 57 to 85. They believe that when a female partner comes between a middle-aged or older man ... Read more

Related support groups: Erectile Dysfunction

Impotence Linked to Restless Legs Syndrome

Posted 15 Jun 2011 by Drugs.com

WEDNESDAY, June 15 – Men who struggle with restless legs syndrome face a higher risk of impotence, a new study suggests. The study, by researchers from Harvard University, builds on earlier research by the scientists that found that impotence, or erectile dysfunction, was more common among older men with restless legs syndrome – and the more frequent the symptoms of the sleep disorder the higher the risk of impotence. For the new study, the researchers started with more than 11,000 men, with an average age of 64 at the start of the trial in 2002, who did not suffer from impotence, diabetes or arthritis. The trial, called the Health Professionals Follow-up Study, began with the men answering a standardized set of health-related questions. Men were considered to have restless legs syndrome (RLS) if they met four RLS diagnostic criteria recommended by the International RLS Study Group ... Read more

Related support groups: Restless Legs Syndrome, Erectile Dysfunction

FDA Medwatch Alert: Via Xtreme Ultimate Sexual Enhancer Dietary Supplement For Men: Recall - Undeclared Drug Ingredient

Posted 7 Jun 2011 by Drugs.com

ISSUE: FDA lab analyses found Via Xtreme Ultimate Sexual Enhancer Dietary Supplement for Men to contain sulfoaildenafil methanesulfonate, sulfosildenafil and dimethylsildenafil analogs of sildenafil. The active drug ingredients are not listed on the product label. Silenafil is an active ingredient of an FDA approved drug for erectile dysfunction (ED), making Via Xtreme an unapproved drug.  BACKGROUND: The undeclared drug ingredients may pose a threat to the consumer because the interaction of the analogue with some prescription drugs (such as nitroglycerin) may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take other prescription drugs. Erectile Dysfunction is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance. RECOMMENDATION: ... Read more

Related support groups: Erectile Dysfunction

FDA Medwatch Alert: ExtenZe Tablets: Recall

Posted 16 May 2011 by Drugs.com

[UPDATED 05/16/2011] Additional counterfeit product lots recalled: LOT 1110075, F050899.   [Posted 02/23/2011] ISSUE: FDA notified Biotab Nutraceuticals, Inc. that two lots of counterfeit product purporting to be ExtenZe contain undeclared drug ingredients. Specifically, lot 0709241 contains tadalafil and sildenafil, and lot 0509075 contains tadalafil and sibutramine. Tadalafil and sildenafil are drugs used to treat erectile dysfunction (ED). These drugs may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek Extenze to enhance sexual performance. Sibutramine is a controlled substance that was withdrawn from the market in October 2010 ... Read more

Related support groups: Erectile Dysfunction

FDA Medwatch Alert: Regenerect: Recall - Undeclared Drug Ingredient

Posted 3 May 2011 by Drugs.com

ISSUE: FDA lab analysis confirmed the presence of Sulfoaildenafil, an analogue of the active ingredient of an FDA-approved drug used to treat erectile dysfunction (ED), making Regenerect an unapproved drug. The product poses a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and they may seek products to enhance sexual performance. BACKGROUND: Ethos Environmental, Inc. distributed Regenerect via sales made over the internet to consumers in the United States of America and Puerto Rico. See the Press Release for specific lot numbers affected by this recall. RECOMMENDATION: Customers in possession of the Regenerect ... Read more

Related support groups: Erectile Dysfunction

FDA Medwatch Alert: X-Hero and Male Enhancer: Recall - Undeclared Drug Ingredient

Posted 16 Apr 2011 by Drugs.com

ISSUE: FDA lab analysis of X-Hero found the product contains sulfosildenafil, the analogue of the active ingredient of an FDA-approved drug used to treat erectile dysfunction (ED), making X-Hero an unapproved drug. In addition, FDA analysis of Male Enhancer sample found the product contains tadalafil, the active ingredient of an FDA-approved drug used to treat erectile dysfunction (ED), making Male Enhancer an unapproved drug. The products pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and they may seek products to enhance sexual performance. BACKGROUND: These two products have been distributed nationwide via ... Read more

Related support groups: Erectile Dysfunction

FDA Medwatch Alert: Best Enhancer: Recall - Undeclared Drug Ingredient

Posted 7 Apr 2011 by Drugs.com

ISSUE: FDA lab analyses found that the products to contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used in the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs. The active drug ingredient is not listed on the product label. BACKGROUND: The undeclared ingredient may pose a threat to the consumer because the interaction of the analogue with some prescription drugs (such as nitroglycerin) may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take other prescription drugs. Erectile Dysfunction is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance. RECOMMENDATION: Consumers who have purchased these products should discontinue their use and return the products to their place of ... Read more

Related support groups: Erectile Dysfunction

Spider Venom -- The Next Way to Treat Impotence?

Posted 16 Jul 2010 by Drugs.com

FRIDAY, Sept. 25 – Scientists may have discovered a novel way to treat erectile dysfunction - using the venom of a deadly spider. The bite from the Brazilian wandering spider (Phoneutria nigriventer) causes a painful erection that can last for many hours and later lead to impotence, researchers from the United States and Brazil noted. After isolating the toxin, the researchers radioactively labeled and injected a purified form of the toxin, Tx2-6, into rats that suffered from high blood pressure and severe erectile dysfunction. The investigators then measured the presence of the toxin in the animals' penises and used the toxin to contract and relax strips of penile tissue. Results showed improved levels of nitric oxide, which led to penile relaxation and erections. The researchers were scheduled to present their work Sept. 24 at the American Heart Association's conference on high blood ... Read more

Related support groups: Erectile Dysfunction

Drugs Like Viagra Linked to Higher Rates of STDs

Posted 6 Jul 2010 by Drugs.com

MONDAY, July 5 – Middle-aged and older men who take erectile dysfunction drugs such as Viagra are more likely to have sexually transmitted diseases, a new study of more than 1.4 million men finds. Researchers at Massachusetts General Hospital and the University of Southern California say the fault lies not with the drugs but rather the high risk behaviors of the men who request them. And doctors should counsel these patients about safe sex practices, they said. Small studies of men who have sex with men have associated the use of ED drugs with higher risk behaviors and increased rates of STDs, but this report, published in the July 6 issue of the Annals of Internal Medicine, is said to be the first to examine the relationship between ED drugs and STD risk in a large, representative sample of privately insured older men. The researchers had no way of knowing how many of the men were ... Read more

Related support groups: Viagra, Erectile Dysfunction, Cialis, Levitra, Sexually Transmitted Diseases

FDA approves Staxyn (vardenafil HCl) orally disintegrating tablets for erectile dysfunction (ED)

Posted 21 Jun 2010 by Drugs.com

Philadelphia, PA & Whitehouse Station, NJ June 18, 2010 – GlaxoSmithKline and Merck & Co., Inc. announced today the U.S. Food and Drug Administration (FDA) has approved Staxyn (vardenafil HCl), an orally disintegrating tablet indicated for the treatment of erectile dysfunction (ED). Staxyn disintegrates on the tongue without liquid. Via a licensing arrangement with Bayer Healthcare Pharmaceuticals, Staxyn will be exclusively marketed in the U.S. by GSK and Merck. GSK and Merck expect to make the medicine available by prescription later this year. Selected Safety Information for Staxyn Contraindications Administration of Staxyn with nitrates and nitric oxide donors is contraindicated. Cardiovascular Effects Treatment for ED, including Staxyn, should not be used in men for whom sexual activity is not recommended because of their underlying cardiovascular status. There are no controlled c ... Read more

Related support groups: Erectile Dysfunction, Vardenafil

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