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More Specialists Question Safety of Testosterone Therapy for Older Men

Posted 17 Feb 2014 by Drugs.com

MONDAY, Feb. 17, 2014 – Following the recent announcement from the U.S. Food and Drug Administration about the potential hazards of using testosterone supplements in older men, another group of experts is raising concerns about the popular treatments. In a statement, specialists in hormonal therapy at the Endocrine Society said the risks and benefits of testosterone supplements for older men with age-related declines in testosterone levels must be investigated more carefully. Older men considering such regimens should be warned about the possible risks, particularly heart-related events such as heart attack and stroke, the group said. The Endocrine Society issued the warning after three recent studies revealed testosterone may not be safe for older men with a history of heart disease. The studies found these men had more heart-related events than men not on testosterone therapy. For ... Read more

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FDA Medwatch Alert: Testosterone Products: Drug Safety Communication - FDA Investigating Risk of Cardiovascular Events

Posted 4 Feb 2014 by Drugs.com

[Posted 01/31/2014] ISSUE: FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. FDA is providing this alert while it continues to evaluate the information from these studies and other available data. FDA will communicate final conclusions and recommendations when the evaluation is complete. BACKGROUND: Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. RECOMMENDATION: At this time, ... Read more

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FDA Will Review Safety of Testosterone Therapy

Posted 3 Feb 2014 by Drugs.com

SUNDAY, Feb. 2, 2014 – Spurred by a recent report that popular testosterone treatments might raise men's heart risk, the U.S. Food and Drug Administration says it now plans a review of the therapies' safety. "FDA is investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products," the agency said in a statement released late Friday. "We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy," the agency added. Testosterone therapy has been widely advertised as a way to help aging men improve low sex drive and reclaim diminished energy. However, in a study published Wednesday in the journal PLoS One, an increased risk of heart attack was found in men younger ... Read more

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Testosterone Therapy Might Increase Heart Attack Risk: Study

Posted 29 Jan 2014 by Drugs.com

WEDNESDAY, Jan. 29, 2014 – Testosterone therapy – widely advertised as a way to help men improve a low sex drive and reclaim diminished energy – might raise the risk of heart attack, according to new research. The increased risk was found in men younger than 65 with a history of heart disease, and in older men even if they didn't have a history of the disease. In both groups, heart attack risk doubled in the 90 days after the men began testosterone therapy, said researcher William Finkle, CEO of Consolidated Research, in Los Angeles. "It was more or less the same increase in risk," Finkle said. Testosterone therapy typically is given in gel, patch or injection form, and is widely promoted in television advertisements about "low T." Although the treatment risk to men over 65 has been documented in previous research, Finkle said, the new study is believed to be the first to look at men ... Read more

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Testosterone Not the Whole Story in 'Male Menopause'

Posted 12 Sep 2013 by Drugs.com

WEDNESDAY, Sept. 11 – Symptoms of so-called "andropause" – the male equivalent of menopause – may be triggered not only by declines in testosterone, but in the "female" hormone estrogen as well, a new study suggests. Experts said the study, published in the Sept. 12 issue of the New England Journal of Medicine, deepens researchers' understanding of the hormonal shifts that occur as men age. And it's more complicated than those ads about "low T" and testosterone supplements might lead men to believe. Instead, researchers found, there is no black-and-white cutoff for "low" or "suboptimal" testosterone. Different symptoms crop up at different testosterone thresholds: Muscle mass and strength do not decline until testosterone drops quite low, whereas libido may dampen with relatively small dips in the hormone. "The question that patients always have is, 'What's a normal testosterone ... Read more

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FDA Medwatch Alert: University Compounding Pharmacy Injection Products: Recall - Lack of Sterility Assurance

Posted 8 Sep 2013 by Drugs.com

ISSUE:  University Compounding Pharmacy is voluntarily recalling products, including Testosterone Cypionate (Sesame Oil), Testosterone Cypionate/Testosterone Proprionate, and PGE-1 NS, for injection, to the consumer level (refer to Recall Notice for a detailed product list with affected lot numbers and expiry dates).  In a recent inspection, FDA investigators observed that methods used by the Independent Third Party laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from the laboratory are not reliable. If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. BACKGROUND: The prescription preparations were distributed nationwide from May 9th, 2013 to September 7th, 2013.The preparations would have been s ... Read more

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Sex Change Hormonal Therapy Deemed Safe

Posted 20 Jun 2013 by Drugs.com

THURSDAY, June 20 – For transsexual people who seek hormonal therapy, a new study offers some welcome news: short-term use of the treatment is safe and effective. Surgery and hormone therapy are options for transsexual (also called transgender) people who want to change their external appearance in order to match what they feel is their true gender. Hormone therapy involves taking large doses of male or female sex hormones, which has led to concerns about possible health risks. The study assessed the effects of short-term hormone therapy among 45 transsexual men and 42 transsexual women at four European centers that specialize in such treatment. The female-to-male transsexuals received a form of the male sex hormone testosterone, and the male-to-female transsexuals received treatment to lower their male hormone levels along with a form of the female sex hormone estrogen. Treatment ... Read more

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FDA Medwatch Alert: Olympia Pharmacy Sterile Compounded Products: Recall - Concerns About Sterility Assurance

Posted 5 Jun 2013 by Drugs.com

  [Posted 05/30/2013] ISSUE: Lowlite Investments d/b/a Olympia Pharmacy ("Lowlite") notified the public of a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The recall is being initiated due to concerns associated with prior quality control procedures that impacted sterility assurance. In the event a sterile product is compromised patients are at risk for serious and possible life threatening infections. The recall includes all sterile products that Olympia Pharmacy supplied to patients and offices of licensed medical professionals with a use by date of 09/25/2013 or earlier. Olympia Pharmacy will be notifying customers by phone, fax, or mail to return the products to the pharmacy. BACKGROUND: To date, Lowlite has received no reports of injury or illness associated with the use of the a ... Read more

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More Men Taking Testosterone, But Risks Unclear

Posted 4 Jun 2013 by Drugs.com

MONDAY, June 3 – Those late-night ads telling aging men that "low T" may be the reason they've lost the spring in their step appear to be reaching their audience. Use of testosterone therapy has increased dramatically over the past decade, according to a new study. But experts worry that too many men may be taking the supplements without understanding the potential risks. Researchers at the University of Texas Medical Branch at Galveston pointed out that the development of new drugs, particularly topical gels, also likely played a role in this trend. The study, published in the current issue of JAMA Internal Medicine, involved more than 10 million men aged 40 years and older. The researchers found use of testosterone therapy was three times higher in 2011 than it was in 2001. Over the course of the decade, testosterone therapy increased from 0.81 percent to 2.91 percent. The ... Read more

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Testosterone Supplements May Hurt Male Fertility, Study Finds

Posted 10 May 2013 by Drugs.com

FRIDAY, May 10 – Testosterone supplements are touted as a cure for low libido, but men who take them may reduce their odds of fathering a child, new research suggests. Many men who sought infertility treatment at two U.S. clinics reported taking prescription testosterone supplements, according to a new study. And in most cases their sperm counts skyrocketed after they stopped taking the male hormone. The study, limited to a pair of clinics in Alabama and Kansas, looked at the years 2005 to 2011. The researchers don't know if testosterone supplements, which continue to gain popularity, are contributing to even more cases of infertility now. Nor is it clear whether the hormone is harming fertility across the nation. Still, the research suggests that testosterone spells trouble for many American men who want to have children, said study co-author Dr. Peter Kolettis, a professor of urology ... Read more

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Buying Testosterone Supplements Online Can Be Risky

Posted 7 May 2013 by Drugs.com

TUESDAY, May 7 – If you're a man suffering from low energy or libido, the drug industry is eager to help. So-called "Low T" – low testosterone – has become a common catch phrase in TV commercials, and sales of testosterone supplements are on the rise in the United States. But a new study suggests that many clinics aren't disclosing the risks of testosterone treatment on their websites. Researchers found that fewer than a third of 70 clinic websites mentioned the side effects of testosterone, although almost all touted potential benefits of treatment like improved sex drive and greater energy. Twenty-one percent, meanwhile, incorrectly denied that hormone treatment is linked to significant side effects. Study co-author Dr. Kevin McVary, chairman of urology at Southern Illinois University School of Medicine, criticized the clinics that failed to be open about the risks of testosterone ... Read more

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Armstrong Confession Validates His Use of Performance-Enhancing Drugs

Posted 18 Jan 2013 by Drugs.com

THURSDAY, Jan. 17 – For over a decade, world-renowned cyclist Lance Armstrong has strongly denied use of performance-enhancing techniques to improve his athletic performance. Armstrong has now admitted in an interview with Oprah Winfrey that he used performance-enhancing drugs while conquering a record seven Tour de France championships. He said it was “not possible” to win without doping. Armstrong admitted to getting lost in the momentum of a perfect life – beating cancer, having a wonderful family and winning the Tours. He said would do anything at all costs to win. And then, Armstrong apologized. The confession, in a “no conditions” interview conducted by Winfrey appears to be the first step in Armstrong’s hope to lessen his lifetime ban, regain his ability to compete, and soften the blows of a damaged reputation. Prior to taping the episode on Monday, Armstrong also made an emo ... Read more

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Testosterone Gel Fails to Boost Viagra's Effects

Posted 20 Nov 2012 by Drugs.com

MONDAY, Nov. 19 – Men who have erectile dysfunction and low testosterone may get no extra benefit from adding the hormone to their Viagra prescription, a new study suggests. The first-choice treatments for erectile dysfunction are drugs called PDE5 inhibitors, which include sildenafil (Viagra), vardenafil (Levitra) and tadalafil (Cialis). They work by helping the smooth muscles of the penis to relax, which increases blood flow. When men with erectile dysfunction also have low testosterone levels, doctors often prescribe testosterone gel along with a PDE5 inhibitor. But now a new clinical trial of 140 men with erectile dysfunction and low levels of testosterone puts that treatment combination into question. "We had expected to see some added benefit from testosterone," said lead researcher Dr. Matthew Spitzer, an endocrinology fellow at Boston University School of Medicine. "But that's ... Read more

Related support groups: Viagra, Erectile Dysfunction, Testosterone, AndroGel, Hypogonadism - Male, Testim, Axiron, Sildenafil, Androderm, Fortesta, Revatio, Testosterone Enanthate, Depo-Testosterone, Delatestryl, Testopel, Testopel Pellets, AndroGel 1.25 g/actuation, Striant, Depotest, Testro

More Testosterone, Less Deceit?

Posted 16 Oct 2012 by Drugs.com

TUESDAY, Oct. 16 – Testosterone, commonly thought of as the male sex hormone, seems to promote honesty, a new study suggests. Testosterone also is naturally found in women but at lower levels than in men, and is typically associated with macho attributes such as aggression and risky behavior. However, recent research indicates that the hormone also encourages social behavior. In the new study, German researchers led by Dr. Matthias Wibral of the University of Bonn department of economics applied a testosterone gel to the skin of 46 men to boost their levels of the hormone and an inactive placebo gel to the skin of 45 other men. Neither the men, nor the researchers, knew which gel was applied to which study participants. All of the men then played games of dice where they could win money. The higher their scores, the more money they received. The researchers structured the games so that ... Read more

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As Armstrong Case Unfolds, Experts Describe Doping's Harms

Posted 11 Oct 2012 by Drugs.com

THURSDAY, Oct. 11 – In the wake of new allegations around Lance Armstrong's involvement in blood doping, experts are reminding the public of the devastating impact these substances can have on an athlete's health. The recent report by the United States Anti-Doping Agency accusing seven-time Tour de France winner Armstrong (he was recently stripped of those titles) of doping participation shows how deeply the practice is ingrained in cycling, but it's a big problem in others sports as well. So-called performance-enhancing drugs – such as erythropoietin, anabolic steroids and human growth hormone – may affect almost every system in the body, and have been linked to severe medical and psychiatric side effects. Add in diuretics to mask all the drugs, and athletes who use performance-enhancing drugs are risking their long-term health, experts say. One of the most common drugs is ... Read more

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