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Low T 116 articles

Judge rules expert witness report is admissable in testosterone replacement therapy MDL

Studies cited in a doctor’s report involving alleged cardiovascular events in men who underwent testosterone replacement therapy are fair game and are admissible in court, said an Illinois federal judge overseeing a multidistrict litigation (MDL) involving testosterone gel AndroGel maker AbbVie Inc. The drug company had asked U.S. District Judge Michael Kennelly to trim Dr. B. Bud Gerstman’s report to the agreed-upon scientific articles pertaining to testosterone treatments and heart health. Gerstman, a professor at San Jose State University, wrote the original report for the plaintiffs’ steering committee in October followed by a rebuttal report that included more information. Judge ... Read More

Antares seeks FDA approval of testosterone shot amid growing litigation involving testosterone side effects

The first trials among thousands accusing drug companies of covering up cardiovascular risks with testosterone therapies begin in 2017, but that isn’t keeping Big Pharma from launching new testosterone products into the market. Antares Pharma Inc., announced it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for QuickShot Testosterone (QST), a drug-device combination product for the delivery of testosterone enanthate using a subcutaneous auto injector. Dozens of testosterone replacement treatments flood the market in various versions including topical gels, creams, nasal sprays, injections and tablets. Antares’ QuickShot auto injector offers a less painful alternative ... Read More

First testosterone side effects trials involve heart attacks, strokes, blood clots

Of the eight cases scheduled to be tried as bellwethers in a multidistrict litigation (MDL) in the Northern District of Illinois involving hundreds of lawsuits alleging cardiovascular risks with testosterone replacement treatments, the first four involve plaintiff claims of heart attack or strokes, and the final four are cases in which plaintiffs allege venous thromboembolism, or blood clots. Plaintiffs include Jeffrey Konrad, Jessee Mitchell, Edward Cribbs, Cecile Frost, Arthur Myers, Froylan Garcia, Robert Nolte and Robert Rowley. While numerous testosterone treatment manufacturers are named in the multidistrict litigation – such as Auxilium Pharmaceuticals Inc., Eli Lilly & Co., and Endo Pharmaceuticals ... Read More

Canadian health officials offer new guidelines for diagnosing, treating Low T

Canadian health officials have issued new guidelines designed to help doctors and patients with the diagnosis and treatment of low testosterone, and to curb over-prescribing in particular to men whose testosterone levels were never checked for low levels of the hormone. The guidelines, published in the Canadian Medical Association Journal, were created by a task force a year after Health Canada warned that testosterone replacement therapy may lead to “serious and possible life-threatening health and blood vessel problems such as heart attack, stroke,” blood clots and irregular heart rhythm. Health Canada has also warned that research suggests that men with ... Read More

FDA warns of abuse risk and heart, mental health side effects with testosterone replacement therapy

The labels on all prescription testosterone replacement therapies have been changed to include a new Warning related to heart and mental health, and to update the Abuse and Dependence section to include new safety information from published literature and case reports regarding risks associated with abuse of and dependence on testosterone and other androgenic steroids (AAS), the Food and Drug Administration (FDA) announced in a drug safety communication. The Anabolic Steroids Control Act of 1990 placed AAS, including testosterone, in Schedule II of the Controlled Substances Act. Testosterone and other AAS are abused by adults and adolescents, including athletes and ... Read More

Study: Testosterone does not improve sexual function

Testosterone replacement therapy may look like the fountain of youth, but a new analysis has found the hormone supplements don’t provide any real benefits as far as improving cardiovascular health, sexual function and cognitive abilities. What testosterone treatments do provide are a laundry list of potential health issues that render the treatments a risky gamble for men. The analysis, published in the journal PLOS One, involved a review of 226 clinical trials conducted between 1950 and 2016 in which testosterone treatments were compared to a placebo for cardiovascular health, sexual function, physical function, mood or cognitive function. “Testosterone has been ... Read More

Judge refuses to toss personal injury lawsuits waged against AndroGel maker Besins

Besins Healthcare sells enough of its testosterone replacement therapy in the United States that lawsuits alleging cardiovascular injuries with testosterone treatments will not be tossed out of a multidistrict litigation (MDL), an Illinois federal judge ruled. The lawsuits claim that Besins and other manufacturers of testosterone treatments invented a disease – Low T – and used fraudulent and aggressive marketing campaigns to lure men into asking their doctors for the treatment off-label despite knowing that use of the products put them at risk for heart attacks, strokes and life threatening blood clot conditions. Besins manufacturers the top selling testosterone treatment AndroGel in ... Read More

Testosterone therapy boosts sex drive but also adverse cardiac events in older men

Older men who use testosterone treatments such as AndroGel, Axiron and Testim to treat low testosterone and low libido are more likely to show renewed interest in sex and to have sex more often than similar men not using the testosterone gels, a new study shows. However, they are also at risk for suffering a cardiovascular event while using the drugs, according to previous studies. Testosterone replacement therapy is intended for men with hypogonadism, a condition in which the body does not produce enough testosterone due to disease or injury. It is not intended for naturally occurring age-related hypogonadism. Despite this, manufacturers of testosterone treatments ... Read More

Direct-to-consumer drug advertising tempts consumers, boosts sales

The U.S. and New Zealand are the only countries in the world that allow pharmaceutical companies to market their drugs directly to consumers. And drug companies have taken full advantage of this opportunity by hammering consumers with drug advertising showing the benefits of testosterone replacement therapy and other treatments. The commercials must reveal related side effects, but with such entertaining graphics, do consumers really pay attention or even care when the explained benefits are so tempting? Testosterone manufacturers have gone so far as to coin the phrase “Low T” – a made up ailment meaning “low testosterone,” with symptoms that include low ... Read More

Testosterone replacement is intriguing but carries serious risks

It is difficult not to be lured by advertisements for testosterone replacement therapies, promising increased sex drive, more muscle mass, and increased energy levels by curing so-called “Low T.” It is even more tempting when reputable sources, like the Mayo Clinic, publish an intriguing review promoting the hormone. But public, beware. Studies have shown that testosterone treatments may not do much to boost libido and may increase the risk of cardiovascular events like heart attacks and strokes But what about that Mayo Clinic article? Consider the source. The review was authored by doctors who worked for the testosterone replacement industry, ... Read More