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'Low T' Therapy Has Yet to Be Proven: FDA

Posted 15 days ago by Drugs.com

WEDNESDAY, Aug. 19, 2015 – Testosterone supplements have long been marketed to aging men as a fountain of youth and virility, but there is still no proof they are safe or effective, according to the U.S. Food and Drug Administration. Writing in the Aug. 20 edition of the New England Journal of Medicine, FDA officials said that only controlled clinical trials can show whether men benefit from treatment to reverse age-related dips in testosterone. The agency is now requiring product manufacturers to conduct those trials. As it stands, testosterone supplements are approved only for men with certain medical conditions that cause abnormally low levels of the hormone – such as damage to brain areas that control testosterone production. But once the FDA approves a drug, doctors are free to prescribe it as they see fit. And most American men on testosterone therapy have no clear medical ... Read more

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Mixed Results on Value of Testosterone Supplements for Men's Health

Posted 11 Aug 2015 by Drugs.com

TUESDAY, Aug. 11, 2015 – Testosterone therapy may not be as bad for men's heart health as previously thought, but it doesn't seem to turn back time on their sex lives either, a new trial shows. "That was the surprising thing," said senior study author Dr. Shalender Bhasin, director of the Boston Claude D. Pepper Older Americans Independence Center at Brigham and Women's Hospital in Boston. "Many middle-aged and older men take testosterone because they feel it will improve their sex life, but the study showed that men who had low-normal or slightly low levels did not show any improvement." Testosterone therapy has become big business in the United States, as baby boomers seek ways to counter the effects of aging, Bhasin said. Sales of testosterone amounted to around $20 million a year in the early 1990s, but by 2012 it had grown into a $2 billion industry, he said. However, recent ... Read more

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Study Sees No Link Between Testosterone Therapy and Blood Clots

Posted 20 Jul 2015 by Drugs.com

MONDAY, July 20, 2015 – Testosterone therapy doesn't appear to increase the risk of blood clots in veins, a new study contends. The most common forms of this problem – called venous thromboembolism (VTE) – are deep vein thrombosis (a clot in the leg) and pulmonary embolism (a clot in the lungs). VTE is the third most common type of cardiovascular problem, after heart attack and stroke, the researchers said. There is conflicting information about the link between testosterone therapy and the risk of VTE. As a result, many men with low testosterone and their doctors are reluctant to start testosterone therapy, the study investigators said. "In 2014, the [U.S.] Federal Drug Administration required manufacturers to add a warning about potential risks of VTE to the label of all approved testosterone products," study author Jacques Baillargeon, a professor of epidemiology at the University ... Read more

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Testosterone Treatments Won't Help Men With Ejaculatory Issues

Posted 9 Jul 2015 by Drugs.com

THURSDAY, July 9, 2015 – Testosterone supplements won't help men with low testosterone ease any problems they have with ejaculatory function, a new study suggests. According to researchers led by Dr. Darius Paduch of NewYork-Presbyterian Hospital/Weill Cornell Medical Center in New York City, issues with ejaculation affect anywhere from 10 percent to 18 percent of men. These conditions include an inability to ejaculate, low ejaculation volumes and force, and delayed time to ejaculation, the researchers said. They added that there is currently no U.S. Food and Drug Administration-approved treatment for ejaculatory dysfunction. Could testosterone replacement therapy help men who face these problems, and who also have low levels of testosterone? "This is the first clinical trial examining the treatment of a very common but poorly understood condition that affects men's physical health as ... Read more

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Hormones May Spur Rash Choices on Stock Exchange

Posted 6 Jul 2015 by Drugs.com

MONDAY, July 6, 2015 – High levels of the hormone testosterone and the fight-or-flight stress hormone cortisol may prompt financial traders to make risky investment choices, researchers say. The finding stems from a pair of simulations conducted in a laboratory setting. "The results suggest that cortisol and testosterone promote risky investment behavior in the short run," study author Dr. Ed Roberts, from the department of medicine at Imperial College London, said in a university news release. "We only looked at the acute effects of the hormones in the lab," he added. "It would be interesting to measure traders' hormone levels in the real world, and also to see what the longer-term effects might be." In the first lab experiment, researchers measured levels of both hormones in more than 140 men and women before asking them to engage in an asset-trading game. In that case, having higher ... Read more

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More Sex, Better Testosterone Levels?

Posted 13 Mar 2015 by Drugs.com

FRIDAY, March 13, 2015 – Experts have long assumed that as a man's testosterone level declines, so does his sex life. But a new study suggests the reverse may be true. "Most people in or out of medicine assume that a lowered serum testosterone may cause reduced sexual activity. But our study questions, if not fully refutes, that assumption and suggests it is the other way around," said Dr. David Handelsman, a researcher at the University of Sydney, in New South Wales, Australia. And skyrocketing sales of testosterone supplements are being fueled by that popular assumption, even though it might not be correct, Handelsman added. But one doctor not involved with the study questioned the finding, noting that other lifestyle factors might be affecting testosterone levels as men age. And the study wasn't designed to take those factors into account. In the study, the researchers evaluated ... Read more

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Early Studies See No Heart Risk From Testosterone Therapy

Posted 4 Mar 2015 by Drugs.com

WEDNESDAY, March 4, 2015 – Testosterone therapy doesn't seem to increase a man's risk of heart attack or stroke, a pair of new studies suggests. "Testosterone therapy in any form – gel, pills or injections – does not appear to cause adverse cardiovascular effects," said Dr. Pawan Patel, lead author of one of the studies and an academic physician at Regions Hospital in St. Paul, Minn. The studies are to be presented next week at the American College of Cardiology (ACC) annual meeting, in San Diego. Research presented at medical meetings is typically viewed as preliminary until published in a peer-reviewed journal. The two studies were released a day after the U.S. Food and Drug Administration issued a warning about the overuse of testosterone-boosting drugs by aging baby boomers trying to use hormone therapy to turn back the clock. The FDA will require all prescription testosterone ... Read more

Related support groups: Ischemic Stroke, Testosterone, Heart Attack, AndroGel, Testim, Axiron, Myocardial Infarction, Androderm, Fortesta, Ischemic Stroke - Prophylaxis, Depo-Testosterone, Testopel, Cardiovascular Risk Reduction, Delatestryl, Testopel Pellets, Striant, AndroGel 1.25 g/actuation, Everone, Testim 5 g/packet, Testosterone Topical

Testosterone May Not Deliver Victory for Athletes, Study Found

Posted 1 Dec 2014 by Drugs.com

MONDAY, Dec. 1, 2014 – Higher levels of testosterone during competition do not improve athletes' chances of victory, a new study finds. "Many people in the scientific literature and in popular culture link testosterone increases to winning," Kathleen Casto, a graduate student in psychology at Emory University in Atlanta, said in a university news release. "In this study, however, we found an increase in testosterone during a race regardless of the athletes' finish time. In fact, one of the runners with the highest increases in testosterone finished with one of the slowest times," she said. Casto and colleagues measured testosterone levels in the saliva of varsity men and women cross-country runners before a race, after they warmed up and at the end of the race. They also checked levels of cortisol, a hormone related to stress. Testosterone levels increased during warm-up, but cortisol ... Read more

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Testosterone Plays Minor Role in Older Women's Sex Lives, Study Finds

Posted 21 Nov 2014 by Drugs.com

THURSDAY, Nov. 20, 2014 – While levels of testosterone and other reproductive hormones have some effect on menopausal women's sex lives, their emotional health and quality of their relationships have a stronger influence, according to a new study. Testosterone is the main sex hormone in men. But, women's ovaries also naturally produce small amounts of the hormone, the researchers noted. The researchers analyzed data from more than 3,300 American women taking part in a long-term study of women's health. They found that women with higher levels of testosterone and another reproductive hormone called dehydroepiandrosterone sulfate (DHEAS) felt sexual desire and masturbated more often than those with low levels of the hormones. However, the links between hormone levels and sexual function were subtle, according to Dr. John Randolph Jr., of the University of Michigan Medical School. ... Read more

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No Testosterone Therapy for Healthy Women, New Guidelines State

Posted 3 Oct 2014 by Drugs.com

FRIDAY, Oct. 3, 2014 – Healthy women should not be diagnosed with testosterone deficiency and should not be prescribed testosterone therapy, a new guideline from the Endocrine Society states. "Although limited research suggests testosterone therapy in menopausal women may be linked to improved sexual function, there are too many unanswered questions to justify prescribing testosterone therapy to otherwise healthy women," guideline task force chair Dr. Margaret Wierman, of the University of Colorado, said in a society news release. "When we reviewed past studies, we found many women who had low testosterone levels measured by older or new techniques did not exhibit any signs or symptoms of concern. As a result, physicians cannot make a diagnosis of androgen deficiency in women," said Wierman, who is vice president of clinical science at the endocrine society. The only time a woman might ... Read more

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FDA Panel: Limit Testosterone Drug Use

Posted 18 Sep 2014 by Drugs.com

THURSDAY, Sept. 18, 2014 – There is little evidence that testosterone replacement therapy effectively treats normally sagging levels of the hormone in aging American males, a U.S. Food and Drug Administration advisory panel said Wednesday. The panel, from two key FDA committees, overwhelmingly voted, 20-1, to tighten use of the popular drugs and require drug makers to conduct tests assessing the drugs' risk of heart attack and stroke, according to Bloomberg News. "The whole idea is to try to rein in the inappropriate advertising and use of these drugs," Dr. Michael Domanski, a panel member who is director of heart failure research at Mount Sinai School of Medicine in New York City, told The New York Times. The FDA is not required to follow the recommendations of its expert panels, but usually does. Along with sharply curtailing how many men might be prescribed testosterone supplements, ... Read more

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FDA to Probe Testosterone Therapy Claims, Safety

Posted 16 Sep 2014 by Drugs.com

TUESDAY, Sept. 16, 2014 – The U.S. Food and Drug Administration is focusing on the "Low T" fad, questioning whether the boom in testosterone replacement therapy is helping or harming the health of aging American males. At a joint meeting scheduled for Sept. 17-18, two key FDA committees will discuss whether doctors are prescribing testosterone therapy for too many men, and if misuse of the male hormone increases the risk of stroke and heart attack. The Baby Boom generation has turned to testosterone replacement therapy in response to the sagging muscles, lower energy levels and sexual problems that can accompany natural aging, the FDA noted in a review provided to committee members in advance of the meeting. "There's a large group of men out there who are getting older, and they are looking for ways to evade the consequences of aging," said Dr. Bradley Anawalt, an endocrinologist from ... Read more

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Latest Study Finds No Link Between Testosterone Supplements, Heart Attack

Posted 2 Jul 2014 by Drugs.com

WEDNESDAY, July 2, 2014 – Although recent research has linked testosterone therapy with a higher risk for heart attack and stroke, a new study involving more than 25,000 older men suggests otherwise. The study, funded by the U.S. National Institutes of Health, may help ease some fears about testosterone therapy for patients and their families, the study authors said. "Our investigation was motivated by a growing concern, in the U.S. and internationally, that testosterone therapy increases men's risk for cardiovascular disease, specifically heart attack and stroke," lead researcher Jacques Baillargeon, an associate professor of epidemiology at the University of Texas Medical Branch at Galveston, said in a university news release. "This concern has increased in the last few years based on the results of a clinical trial and two observational studies," he said. "It is important to note, ... Read more

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FDA Medwatch Alert: Testosterone Products: FDA/CDER Statement - Risk of Venous Blood Clots

Posted 24 Jun 2014 by Drugs.com

[Posted 06/20/2014] ISSUE:  FDA notified health professionals and their medical care organizations that it is requiring the manufacturers of all approved testosterone products to include a warning in the drug labeling about the risk of blood clots in the veins, also known as venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). BACKGROUND: The risk of venous blood clots as a possible consequence of polycythemia is already included in the labeling of testosterone products. Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots, to ensure this risk is described consistently in the labeling of all approved testosterone products. RECOMMENDATION: Note - This new warning, a class l ... Read more

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Testosterone Products Must Warn About Risk of Venous Clots: FDA

Posted 22 Jun 2014 by Drugs.com

FRIDAY, June 20, 2014 – The growing unease around the safety of testosterone supplements was highlighted Friday with a U.S. Food and Drug Administration announcement that the products must now carry a warning label on the general risk of blood clots in the veins. Testosterone therapy has been widely advertised as a way to help aging men with so-called "low T" improve their sex drive and reclaim diminished energy. The products already carry a warning about the risk of blood clots in the veins due to polycythemia, an abnormal rise in the number of red blood cells that sometimes occurs with testosterone treatment. In its statement Friday, the FDA said that after receiving reports of blood clots in the veins unrelated to polycythemia in patients taking testosterone products, it has now decided to require a more general warning on venous blood clots on the labelling. Blood clots in the ... Read more

Related support groups: Testosterone, AndroGel, Testim, Axiron, Androderm, Fortesta, Depo-Testosterone, Testopel, Delatestryl, Testopel Pellets, Striant, AndroGel 1.25 g/actuation, Testim 5 g/packet, Everone, Aveed, Depotest, Testro, Testro AQ, Durathate 200, Virilon IM

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