Join the 'Testopel' group to help and get support from people like you.

Testopel Blog

FDA Panel: Limit Testosterone Drug Use

Posted 12 days ago 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, Hypogonadism - Male, Testim, Axiron, Androderm, Fortesta, Depo-Testosterone, Testopel, Delatestryl, Testopel Pellets, Everone, Striant, AndroGel 1.25 g/actuation, Testro, Testim 5 g/packet, Depotest, Andro-Cyp 200, Meditest, Testamone-100

FDA to Probe Testosterone Therapy Claims, Safety

Posted 14 days ago 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, Hypogonadism - Male, Testim, Axiron, Androderm, Fortesta, Depo-Testosterone, Testopel, Delatestryl, Testopel Pellets, Everone, Striant, AndroGel 1.25 g/actuation, Testro, Testim 5 g/packet, Depotest, Andro-Cyp 200, Meditest, Testamone-100

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

Related support groups: Testosterone, Heart Attack, AndroGel, Testim, Axiron, Myocardial Infarction, Androderm, Fortesta, Depo-Testosterone, Testopel, Delatestryl, Testopel Pellets, Everone, Striant, AndroGel 1.25 g/actuation, Testro, Testim 5 g/packet, Depotest, Andro-Cyp 200, Meditest

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, Hypogonadism - Male, Testim, Axiron, Androderm, Fortesta, Depo-Testosterone, Testopel, Delatestryl, Testopel Pellets, Everone, Striant, AndroGel 1.25 g/actuation, Testro, Testim 5 g/packet, Depotest, Andro-Cyp 200, Meditest, Testamone-100

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, Everone, Striant, AndroGel 1.25 g/actuation, Testro, Testim 5 g/packet, Depotest, Andro-Cyp 200, Meditest, Bio-T-Gel, Testamone-100

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, Hypogonadism - Male, Testim, Axiron, Androderm, Fortesta, Depo-Testosterone, Testopel, Delatestryl, Testopel Pellets, Everone, Striant, AndroGel 1.25 g/actuation, Testro, Testim 5 g/packet, Depotest, Andro-Cyp 200, Meditest, Testamone-100

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, Hypogonadism - Male, Testim, Axiron, Androderm, Fortesta, Depo-Testosterone, Testopel, Delatestryl, Testopel Pellets, Everone, Striant, AndroGel 1.25 g/actuation, Testro, Testim 5 g/packet, Depotest, Andro-Cyp 200, Meditest, Testamone-100

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, Hypogonadism - Male, Testim, Axiron, Androderm, Fortesta, Depo-Testosterone, Testopel, Delatestryl, Testopel Pellets, Everone, Striant, AndroGel 1.25 g/actuation, Testro, Testim 5 g/packet, Depotest, Andro-Cyp 200, Meditest, Testamone-100

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

Related support groups: Testosterone, AndroGel, Testim, Axiron, Androderm, Fortesta, Depo-Testosterone, Testopel, Delatestryl, Testopel Pellets, Everone, Striant, AndroGel 1.25 g/actuation, Testro, Testim 5 g/packet, Depotest, Andro-Cyp 200, Meditest, Bio-T-Gel, Testamone-100

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

Related support groups: Testosterone, AndroGel, Testim, Axiron, Androderm, Fortesta, Depo-Testosterone, Testopel, Delatestryl, Testopel Pellets, Everone, Striant, AndroGel 1.25 g/actuation, Testro, Testim 5 g/packet, Depotest, Andro-Cyp 200, Meditest, Bio-T-Gel, Testamone-100

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

Related support groups: Testosterone, AndroGel, Hypogonadism - Male, Testim, Axiron, Androderm, Fortesta, Depo-Testosterone, Testopel, Delatestryl, Testopel Pellets, Everone, Striant, AndroGel 1.25 g/actuation, Testro, Testim 5 g/packet, Depotest, Andro-Cyp 200, Meditest, Testamone-100

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

Related support groups: Testosterone, Estradiol, AndroGel, Estrace, Testim, Axiron, Vivelle, Climara, Vivelle-Dot, Androderm, Estradiol Patch, Fortesta, Evamist, Minivelle, Depo-Testosterone, Estraderm, Femring, Testopel, Delatestryl, Divigel

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

Related support groups: Provera, Subutex, Depo-Provera, Testosterone, Meloxicam, Estradiol, Butrans, AndroGel, Mobic, Methylprednisolone, Medroxyprogesterone, Estrace, Buprenorphine, Medrol, Testim, Axiron, Reglan, Vivelle, Climara, Atropine

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

Related support groups: Testosterone, AndroGel, Testim, Axiron, Androderm, Fortesta, Depo-Testosterone, Testopel, Delatestryl, Testopel Pellets, Everone, Striant, AndroGel 1.25 g/actuation, Testro, Testim 5 g/packet, Depotest, Andro-Cyp 200, Meditest, Bio-T-Gel, Testamone-100

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

Related support groups: Testosterone, AndroGel, Hypogonadism - Male, Testim, Axiron, Androderm, Fortesta, Depo-Testosterone, Testopel, Delatestryl, Oligospermia, Testopel Pellets, Everone, Striant, AndroGel 1.25 g/actuation, Testro, Testim 5 g/packet, Depotest, Andro-Cyp 200, Meditest

Page 1 2 Next

Ask a Question

Further Information

Related Condition Support Groups

Hypogonadism - Male, Delayed Puberty - Male, Breast Cancer - Palliative, Postpartum Breast Pain

Testopel Patient Information at Drugs.com