Testosterone Drugs May Be Overused, FDA Warns

WASHINGTON (AP) — The Food and Drug Administration is warning doctors against over-prescribing testosterone-boosting drugs for men, saying the popular treatments have not been established as safe or effective for common age-related issues like low libido and fatigue. The agency says drugmakers must clearly state in their labeling and promotions that the drugs, currently taken by millions of U.S. men, are only approved to treat low testosterone levels caused by disease or injury, not normal aging. Additionally, the FDA cautioned that the drugs may increase the risk of heart attack, stroke and other cardiovascular problems. Drugmakers must add information about that potential risk to their prescribing labels and conduct a long-term study to further examine the issue, the FDA said. Health officials in Canada issued a similar warning about testosterone risks last July. The FDA action follows years of industry marketing for new gels, patches and injections that promise relief from low testosterone or "Low-T." Promotions from AbbVie, Eli Lilly &Co. and others link the condition to a variety of common ailments in aging men, including sexual problems and low mood. "There's been a very successful advertising campaign to make men feel that whatever their problem is, the answer is to buy more testosterone," said Dr. Sidney Wolfe of Public Citizen. The consumer advocacy group petitioned the FDA last February to add a boxed warning — the most seriou...
Source: Science - The Huffington Post - Category: Science Source Type: news

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(Elsevier) Aging men with low testosterone levels who take testosterone replacement therapy (TRT) are at a slightly greater risk of experiencing an ischemic stroke, transient ischemic attack (TIA), or myocardial infarction, especially during the first two years of use, reports a study appearing in The American Journal of Medicine, published by Elsevier. The findings confirm concerns voiced by many health agencies about the potential risks associated with the treatment.
Source: EurekAlert! - Medicine and Health - Category: International Medicine & Public Health Source Type: news
We assessed the risk of ischemic stroke, transient ischemic attack, and myocardial infarction associated with testosterone replacement therapy (TRT) among aging men with low testosterone levels.
Source: The American Journal of Medicine - Category: General Medicine Authors: Tags: Clinical Research Study Source Type: research
AbstractBackgroundThe risk of adverse cardiovascular events and mortality associated with testosterone replacement therapy is controversial. The purpose of this report was to evaluate the effect of testosterone replacement therapy (TRT) in men with secondary hypogonadism on the risk of myocardial infarction (MI), stroke (CVA) or all-cause mortality.MethodsA retrospective cohort study was conducted using the Cleveland Clinic ’s electronic health record. Men ≥40 years of age, with at least two testosterone levels
Source: Basic and Clinical Andrology - Category: Urology & Nephrology Source Type: research
Publication date: 2014Source: Yearbook of Urology, Volume 2014Author(s): A.W. Shindel
Source: Yearbook of Urology - Category: Urology & Nephrology Source Type: research
Conclusions: We recommend making a diagnosis of hypogonadism only in men with symptoms and signs consistent with testosterone (T) deficiency and unequivocally and consistently low serum T concentrations. We recommend measuring fasting morning total T concentrations using an accurate and reliable assay as the initial diagnostic test. We recommend confirming the diagnosis by repeating the measurement of morning fasting total T concentrations. In men whose total T is near the lower limit of normal or who have a condition that alters sex hormone-binding globulin, we recommend obtaining a free T concentration using either equil...
Source: Clinical Genitourinary Cancer - Category: Cancer & Oncology Authors: Tags: J Clin Endocrinol Metab Source Type: research
[03-03-2015] The U.S. Food and Drug Administration (FDA) cautions that prescription testosterone products are approved only for men who have low testosterone levels caused by certain medical conditions.
Source: FDA Center for Drug Evaluation and Research - What's New - Category: Drugs & Pharmacology Source Type: news
In July 2017, a Chicago jury found AbbVie Inc. guilty of fraudulently misrepresenting the risks of its testosterone replacement drug AndroGel. The federal jury ordered the company to pay $150 million in punitive damages. Allegations The verdict comes in a case where Jesse Mitchell blamed the drug for a heart attack he had in 2012 after four years of taking AndroGel. Mitchell, who used AndroGel from 2008 to 2012, alleged that AbbVie knew or should have known the drug could cause cardiovascular disease, strokes and other serious injuries, but failed to adequately warn consumers and doctors. He was 49 at the time of his hea...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs
Testosterone replacement therapy may lower the risk for myocardial infarction, stroke and all-cause mortality in men with secondary hypogonadism, according to research presented at the Annual Scientific and Clinical Congress.Healio
Source: Society for Endocrinology - Category: Endocrinology Source Type: news
Test your medicine knowledge with the MKSAP challenge, in partnership with the American College of Physicians. A 52-year-old man is evaluated for the sudden onset of erectile dysfunction that has persisted for 6 months. He reports having erections that are inadequate for vaginal penetration. He feels guilty about not being able to satisfy his wife’s requests for sexual intercourse, although he still has sexual desires. He has been sleeping poorly and feeling fatigued throughout the day. He reports no snoring or daytime somnolence, and his review of systems is otherwise negative. His wife does not repor...
Source: Kevin, M.D. - Medical Weblog - Category: Journals (General) Authors: Tags: Conditions Primary care Source Type: blogs
AbstractIn the last decade, testosterone replacement therapy (TRT) has been increasingly prescribed to treat a controversial condition known as ‘late-onset hypogonadism (LOH)’. This syndrome is diagnosed in men who, for no discernible reason other than older age, obesity or ill health have serum testosterone concentrations below the normal range for healthy young men and report one or more of the following symptoms: muscle weakness or wasting, mood, behaviour and cognition-related symptoms and sexual function or libido impairment. However, recent evidence has demonstrated that testosterone drugs do not substant...
Source: Human Reproduction - Category: Reproduction Medicine Source Type: research
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