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Hypogonadism - Male News

Related terms: Low Testosterone, Low T, Hypogonadotropic Hypogonadism - Male, Primary Hypogonadism - Male

FDA Medwatch Alert: Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement - Risks Associated With Abuse and Dependence

Posted 25 Oct 2016 by Drugs.com

ISSUE: FDA approved class-wide labeling changes for all prescription testosterone products, adding a new Warning and updating the Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of testosterone and other AAS.  The Anabolic Steroids Control Act of 1990 placed AAS, including testosterone, in Schedule III of the Controlled Substances Act. Testosterone and other AAS are abused by adults and adolescents, including athletes and body builders. Abuse of testosterone, usually at doses higher than those typically prescribed and usually in conjunction with other AAS, is associated with serious safety risks affecting the heart, brain, liver, mental health, and endocrine system. Reported serious adverse outcomes include heart attack, heart failure, stroke, depression, hostility, ... Read more

Related support groups: Testosterone, AndroGel, Testim, Axiron, Androderm, Hypogonadism - Male, Depo-Testosterone, Testopel, Fortesta, Testopel Pellets, Testim 5 g/packet, Delatestryl, AndroGel 1.25 g/actuation, Striant, Depandro 100, Meditest, Depotest, Testro, Vogelxo, Testamone-100

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

Related support groups: Testosterone, AndroGel, Testim, Axiron, Androderm, Hypogonadism - Male, Depo-Testosterone, Testopel, Fortesta, Testopel Pellets, Delatestryl, Testim 5 g/packet, Striant, AndroGel 1.25 g/actuation, Depandro 100, Bio-T-Gel, Depotest, Testro AQ, Vogelxo, Virilon IM

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

Related support groups: Testosterone, AndroGel, Testim, Axiron, Androderm, Hypogonadism - Male, Depo-Testosterone, Testopel, Fortesta, Testopel Pellets, Delatestryl, Testim 5 g/packet, Striant, AndroGel 1.25 g/actuation, Depandro 100, Bio-T-Gel, Depotest, Testro AQ, Vogelxo, Virilon IM

Common Chemicals May Lower Testosterone Levels, Study Finds

Posted 14 Aug 2014 by Drugs.com

THURSDAY, Aug. 14, 2014 – Exposure to certain chemicals commonly found in plastics and other products is associated with lower levels of testosterone in men, women and children, a new study says. Testosterone is the main sex hormone in men, but it is also involved in a variety of functions in both men and women, including brain function, bone density, physical growth, strength and heart health. The University of Michigan researchers studied exposure to chemicals called phthalates and testosterone levels in more than 2,200 people who took part in the 2011-12 U.S. National Health and Nutrition Examination Survey. Phthalates are found in flexible PVC plastics and many personal care products, according to the study published online Aug. 14 in the Journal of Clinical Endocrinology & Metabolism. "We found evidence of reduced levels of circulating testosterone were associated with increased ... 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

Related support groups: Testosterone, AndroGel, Testim, Axiron, Androderm, Hypogonadism - Male, Depo-Testosterone, Testopel, Fortesta, Testopel Pellets, Delatestryl, Testim 5 g/packet, Striant, AndroGel 1.25 g/actuation, Depandro 100, Bio-T-Gel, Depotest, Testro AQ, Virilon IM, Durathate 200

Upsher-Smith Receives Final NDA Approval For Vogelxo (testosterone) Gel

Posted 9 Jun 2014 by Drugs.com

Maple Grove, MN – June 4, 2014 – Upsher-Smith Laboratories, Inc., today announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Vogelxo™ (testosterone) gel for topical use CIII. The company is preparing to launch Vogelxo™ in the near future. About Upsher-Smith Upsher-Smith Laboratories, Inc., founded in 1919, is a growing pharmaceutical company dedicated to its mission of Advancing Pharmacotherapy. Improving Life™. With capabilities ranging from early-stage research to delivering on-market products, Upsher-Smith is committed to offering quality products that enable people to live life to its greatest potential. Upsher-Smith's approach to product development and partnering has resulted in a broad range of both branded and generic therapeutic solutions to address patients’ needs. The Company has a particular focu ... Read more

Related support groups: Testosterone, Hypogonadism - Male

FDA Approves Natesto (testosterone) Nasal Gel to Treat Men with Low Testosterone

Posted 6 Jun 2014 by Drugs.com

TORONTO (May 28, 2014) – Trimel Pharmaceuticals Corporation (TSX: TRL) announced today that the United States Food and Drug Administration (FDA) has approved Natesto (testosterone), formerly CompleoTRT™, the first and only testosterone nasal gel for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Natesto is self-administered via a nasal applicator thereby minimizing the risk of secondary exposure to testosterone of women or children. “In my practice I regularly encounter men demonstrating symptoms of hypogonadism and physicians will increasingly see this as the North American population ages,” said Dr. Jeffrey Rosen, the medical director and founder of Clinical Research of South Florida (CRSA). “For these patients seeking to restore their testosterone levels, Natesto™ will offer an alternative delivery system that is ... Read more

Related support groups: Testosterone, Hypogonadism - Male

'Low T' Diagnosis Needs More Than a Blood Test, Experts Say

Posted 10 Mar 2014 by Drugs.com

MONDAY, March 10, 2014 – A blood test alone is not enough to diagnose low testosterone levels in men, and it should be used in tandem with a physical exam, a panel of experts says. The number of men in the United States diagnosed with low testosterone has increased significantly over the last decade, they noted. However, inconsistent laboratory practices and other problems result in unreliable blood test results for the condition. Testosterone is the major male sex hormone. The lack of consistency in laboratory practices occurs in areas such as blood-sample collection and storage and the methods used to analyze blood samples. The panel of doctors from six major U.S. institutions analyzed data from more than 10,000 patients. Their findings were published online March 6 ahead of print in the May issue of the journal Urology. "In some cases, testosterone levels, tested on the same day ... Read more

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FDA Approves Aveed (testosterone undecanoate) Injectable Testosterone Replacement Therapy

Posted 6 Mar 2014 by Drugs.com

DUBLIN, March 6, 2014 /PRNewswire/ – Endo International plc announced today that its operating company Endo Pharmaceuticals Inc. received U.S. Food and Drug Administration (FDA) approval of Aveed (testosterone undecanoate) injection for the treatment of adult men with hypogonadism (commonly known as Low-T) that is associated with a deficiency or absence of the male hormone testosterone. Aveed is a new prescription medicine indicated to produce serum testosterone levels in the normal range by administration of a single 3-mL (750 mg) intramuscular injection given once at initiation of therapy, at 4 weeks, and then every 10 weeks thereafter. It is expected to be available in early March. "Today's FDA approval of Aveed is a significant milestone for Endo. Aveed expands our branded portfolio of men's health products and highlights our passion and commitment to providing high quality ... Read more

Related support groups: Testosterone, Hypogonadism - Male, Hypogonadism, Low T

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

Related support groups: Testosterone, AndroGel, Testim, Axiron, Androderm, Hypogonadism - Male, Depo-Testosterone, Testopel, Fortesta, Testopel Pellets, Delatestryl, Testim 5 g/packet, Striant, AndroGel 1.25 g/actuation, Depandro 100, Bio-T-Gel, Depotest, Testro AQ, Virilon IM, Durathate 200

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

Related support groups: Testosterone, AndroGel, Testim, Axiron, Androderm, Hypogonadism - Male, Depo-Testosterone, Testopel, Fortesta, Testopel Pellets, Delatestryl, Testim 5 g/packet, Striant, AndroGel 1.25 g/actuation, Depandro 100, Bio-T-Gel, Depotest, Testro AQ, Virilon IM, Durathate 200

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

Related support groups: Testosterone, AndroGel, Testim, Axiron, Androderm, Hypogonadism - Male, Depo-Testosterone, Testopel, Fortesta, Testopel Pellets, Delatestryl, Testim 5 g/packet, Striant, AndroGel 1.25 g/actuation, Depandro 100, Bio-T-Gel, Depotest, Testro AQ, Virilon IM, Durathate 200

'Low T' Therapy: Is It for Me?

Posted 2 Jan 2014 by Drugs.com

WEDNESDAY, Jan. 1, 2014 – When men are young, testosterone tends to get a bad rap, often blamed for aggressive and overly competitive behavior. But as men get older, the bad rap continues, though for a different reason. In older men, it's low testosterone that has captured attention. Testosterone, the male hormone, plays a vital role in many body functions, and low testosterone levels can leave men tired, uninterested in sex, infertile and with thinning bones, according to the U.S. National Library of Medicine. It's also a fairly common problem in older men. As many as four in 10 men older than 45 have lower than normal levels of testosterone, according to the American Urological Association. But, replacing lost testosterone isn't a panacea, despite what you might have seen on TV. "There's been a lot of advertising, and every guy that comes in now asks about testosterone," said Dr. ... Read more

Related support groups: Hypogonadism - Male

Too Much Testosterone May Be Unhealthy for Older Men

Posted 21 Nov 2013 by Drugs.com

WEDNESDAY, Nov. 20, 2013 – Older men with higher or lower testosterone levels are more likely to die early than those with mid-range levels of the male sex hormone, a new study suggests. It was already known that low testosterone levels were associated with health problems, but this study suggests that high levels of the hormone are also a problem. Researchers measured the testosterone levels of nearly 3,700 Australian men, aged 70 to 89, between 2001 and 2004. They then checked to see how many were still alive in December 2010. Those with the lowest testosterone levels had the highest death rate, followed by those with the highest levels. Men with mid-range levels of testosterone had the highest survival rate, according to the study, which was published recently in the Journal of Clinical Endocrinology & Metabolism. "When the body metabolizes testosterone, it produces ... Read more

Related support groups: Hypogonadism - Male

Low Testosterone Linked to Possible Heart Problems in Men

Posted 24 Sep 2013 by Drugs.com

TUESDAY, Sept. 24 – Men with low testosterone may have a slightly increased risk of developing or dying from heart disease, according to a new review. Researchers analyzed studies that looked at testosterone levels and cardiovascular disease and were published between 1970 and 2013. Testosterone is a male sex hormone involved in sex drive, sperm production and bone health. Over time, low testosterone may contribute to an increase in body fat and a loss of muscle bulk and body hair. The review, which will be published in the Journal of Clinical Endocrinology & Metabolism, showed increasing evidence suggesting a connection between low testosterone levels and heart disease. The review, however, did not establish a cause-and-effect relationship between low testosterone in men and heart disease risk. Among other findings were the following: Treatment with testosterone-replacement therapy ... Read more

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