An FDA advisory panel has voted 20–1 to restrict the use of testosterone replacement therapies to serious medical conditions that cause testosterone deficiency, such as hypogonadism due to genetic disorders or chemotherapy. The panel noted that there is no clear evidence that these therapies are effective for treating age–related low testosterone, known as low T.
Between 2009 and 2013, the use of these products increased by 65%, primarily driven by higher usage in patients with low levels of the hormone caused by aging. One panel member noted that the FDA’s goal is to “rein in the inappropriate advertising and use of these drugs.” The advisory panel also recommended that pharmaceutical companies be required to conduct additional studies to assess the cardiovascular risk of these products for heart attack and stroke.
Taken from U.S. Pharmacist
Vitality and strength, two valuable attributes for many men. But how many males are putting their health on the line with testosterone replacement therapy? An FDA Panel recently voted to address its use. I'm Miranda Savioli with your latest health news.
An FDA committee recently voted 20 to 1 to tighten use of TRT. The panel reviewed a previous study that suggested men on TRT had a 30 percent increased risk of heart problems; they also requested further research into the link. The panel recommended the FDA labels TRT more strictly- for men with medically low testosterone only, such as testicular cancer patients. The FDA could also stop manufactures from advertising the medication for age-related testosterone loss.
Always discuss potential side effects with your doctor before taking a new medication.
Taken from DailyRX.
Treatment for opioid addiction tampers with the testosterone levels of male but not female opioid users, McMaster University research has shown. In a paper published by the journal Scientific Reports, the researchers say addiction treatment may need to change to address the side–effect. The study found men using methadone, which is used for opioid addiction treatment, have significantly suppressed testosterone levels of about a quarter of the testosterone of men not using opioids. In women using methadone for addiction treatment, testosterone levels were not significantly impacted, even considering the menstrual cycle.
Low testosterone in men has been associated with poor quality of life as well as erectile dysfunction, fatigue and mood disturbances. "We expect that treating testosterone deficiency will improve outcomes of methadone treatment for patients, including treatment response and retention," said Dr. Zena Samaan, principal investigator of the study. "Doctors should also ensure the patients are being prescribed the lowest dose of opioids including methadone for effective treatment to minimize testosterone suppression."
Taken from McMaster University Faculty of Health Sciences News
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). 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.
This new warning, a class labeling change, is not related to an ongoing FDA evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products. FDA is currently evaluating the potential risk of these cardiovascular events, which are related to blood clots in the arteries and are described in a January 31, 2014 MedWatch Safety Alert.
Taken from FDA
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