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testosterone side effects 53 articles

Georgia man sues testosterone treatment makers alleging serious injuries

A Georgia man has joined a lawsuit against several manufacturers of testosterone replacement therapies alleging the hormone treatment caused him to suffer numerous injuries including deep vein thrombosis. He claims the drug companies aggressively marketed the drugs to consumers but failed to warn of dangerous testosterone side effects. Johnny Hall’s lawsuit names Endo Pharmaceuticals Inc., Auxillium Pharmaceuticals Inc, GlaxoSmithKline LLC, Eli Lily and Company, Lilly USA LLC, Acrux Commerical Pty Ltd., and Acrux DDS Pty Ltd. He filed the suit in the U.S. District Court for the Northern District of Illinois. According to his complaint, Hall developed deep vein thrombosis ... Read More

Aggressive ad campaigns led to dramatic increases in testosterone use

Aggressive marketing campaigns waged by makers of testosterone replacement therapies promising men stronger libidos, increased muscle mass, and weight loss resulted in dramatic increases in the number of men taking the hormonal supplements, according to a new study published in the Journal of the American Medical Association. The study, conducted by researchers with the University of North Carolina, Chapel Hill, analyzed data on the initiation of testosterone treatment and use based on commercial insurance claims with ratings in 75 television markets from 2009 to 2013. The study area included more than 17 million commercially insured men. Researchers found that more ... Read More

Testosterone replacement therapy increases plaque buildup in arteries of older men

A group of older men treated with AbbVie’s AndroGel testosterone replacement therapy for a year had a 20 percent greater buildup of non-calcified plaque in their arteries than men who received a placebo gel, according to a study published in the Journal of the American Medical Association. The men – 138 in total – had a mean age of 71 as well as having cardiovascular risk factors. Half had severe atherosclerosis, a buildup of fats, cholesterol, and other substances in and on the artery walls, which can cause blockages that can lead to conditions such as coronary artery disease, chronic ... Read More

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

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

AndroGel makers try to shake testosterone side effects lawsuits

AbbVie Inc., and Abbott Laboratories are trying to wiggle their way out of a massive multidistrict litigation (MDL) over side effects allegedly caused by testosterone replacement therapies by arguing to an Illinois federal judge that plaintiffs have not shown that use of testosterone supplements increases the risk of heart attacks or strokes. Days earlier, the drug companies filed a separate summary judgment arguing that plaintiffs’ claims that they marketed testosterone treatments for unapproved uses was incorrect because Food and Drug Administration (FDA) officials had OK’d their marketing materials. The motions for summary judgment were filed just months before the companies ... Read More

AbbVie fights sharing physician notes with lawyers suing over testosterone replacement therapy side effects

Drug maker AbbVie Inc., embroiled in lawsuits alleging its testosterone replacement therapy AndroGel caused heart attacks, strokes and blood clots, told an Illinois federal judge that allowing plaintiffs access to documents belonging to a doctor employed by the company was beyond what was proper in the multidistrict litigation (MDL). The plaintiffs steering committee (PSC) asked U.S. District Judge Matthew Kennelly to compel AbbVie to produce the documents of Dr. Adrian Dobbs, an endocrinologist and professor at The Johns Hopkins University School of Medicine, who plaintiffs consider a “key opinion leader” with the drug company because she was paid to persuade ... Read More

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

Top FDA Safety Alerts for 2016

The Food and Drug Administration (FDA) issued Safety Alerts for 60 drugs or therapeutic biological products during 2016. Here are some of the most notable safety issues: April 5 – Type 2 diabetes medications containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease, the FDA warned. Brand-name drugs listed in this warning include Onglyza, Kombiglyze XR, Nesnia, Kazano, and Oseni. May 3 – A number of cases of compulsive or uncontrollable urges to gamble, binge eat, shop and have sex were reported with the antipsychotic drug aripiprazole resulting ... 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