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Low T 91 articles

Testosterone replacement therapy makers can’t dodge trials


U.S. District Judge Matthew Kennelly dissed almost all the arguments AbbVie and Abbott Laboratories made for a summary judgment before the first of seven bellwether trials involving cardiovascular risks with the testosterone replacement treatment AndroGel begins, Law360 reported. The drug companies face more than 7,000 lawsuits in a sprawling multidistrict litigation (MDL) involving several different manufacturers of testosterone replacement therapies. As the maker of the top selling AndroGel, AbbVie will sit in the hot seat for all seven of the selected bellwethers. The first trial is set to begin in June. Plaintiffs suing AbbVie and other testosterone treatment manufacturers allege ... Read More

direct-to-consumer advertising likely increases testosterone treatment sales

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The U.S. and New Zealand are the only countries in the world that allow drug companies to advertise directly to consumers. A new study published in the Journal of the American Medical Association (JAMA) shows just how powerful that opportunity is for Big Pharma. Direct-to-consumer advertising in the U.S. increased substantially from 2009 to 2013. The study focused on the marketing of testosterone replacement therapies, the biggest selling product being AndroGel manufactured by AbbVie. Testosterone therapy is intended for men with hypogonadism, a condition in which the body does not produce enough of the male hormone due to defect or ... Read More

Dangerous blood clots more likely during first six months of testosterone treatment

Low T

Men using testosterone replacement therapy have a 63 percent increased risk of developing life threatening blood clots during the first six months of treatment, but this testosterone side effect may have run under the radar in previous studies due to methodological issues, according to a study published in the British Medical Journal. Blood clots that start in the vein are called venous thromboembolism (VTE). The two types of VTE include deep vein thrombosis (DVT), a clot in the deep vein, usually the leg but can be in the arm or other veins; and pulmonary embolism (PE), when a DVT clot ... Read More

Study: Testosterone treatment has no effect on memory, mental function in older men

Low T

Testosterone replacement therapy is approved for the treatment of hypogonadism, a condition in which men do not produce enough of the male hormone due to disease, injury or defect. But manufacturers of testosterone treatments have heavily promoted the product to treat symptoms of so-called “Low T,” such as low libido, memory loss, weight gain, muscle loss and mood swings. The marketing strategy worked surprisingly well, resulting in skyrocketing sales of testosterone replacement therapies that eventually raised concerns that the drugs were being prescribed to men who actually didn’t need it, such as older men who naturally see a dip in ... Read More

Study: Testosterone replacement therapy ups blood clot risk as much as 63 percent

Low T

Men who use testosterone replacement therapy have a 63 percent increased risk of developing a life-threatening blood clot in a vein, and the risk peaks rapidly during the first six months of use, according to a study led by Dr. Carlos Martinez of the Institute for Epidemiology, Statistics and Informatics in Frankfurt, Germany. Blood clots in the veins, a condition known as venous thromboembolism (VTE), is serious. The clot can travel to the heart and cause a heart attack, to the brain and cause stroke, or to the lungs, a condition known as pulmonary embolism. All of these blood clot-related problems ... Read More

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

Low T

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

Low T

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

Low T

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

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

Low T

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