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In 2015, the FDA issued a safety announcement to men using testosterone products. The agency noted these products are linked to increased risk of heart attack, stroke and cardiac death, and required manufacturers of popular products like AndroGenl, Axiron, and Testim to update labels.
This federal action was in response to several studies linking T-Therapy to heart risks. One study found men using T-Therapy were 30% more likely to have a heart attack, stroke, or die after three years of use.
Testosterone replacement therapy is marketed to aging men experiencing a natural decline in testosterone. The dangerous drug attorneys at Pintas & Mullins Law Firm are currently investigating cases of stroke, heart attack, and other cardiac events in patients who were prescribed a T-Therapy gel, patch or shots.
Have you been harmed by a testosterone therapy drug? Our free case reviews are available to anyone injured by prescription drugs nationwide. Our firm partners with other top law firms across the nation in order to bring you the best representation possible—at the price of just one firm.
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Testosterone Therapy “Benefits”
Testosterone naturally declines in men as they age, causing symptoms like decreased sex drive, low energy, bone density, muscle strength, and changes in fat distribution. Although this is a normal process that every man experiences, Big Pharma saw it as an opportunity to prey on men’s vulnerabilities and invented a condition called “low T.”
T-Therapy drugs – the supposed antidote to low T – claim to renew energy levels, boost libido, and improve muscle mass, among other miraculous cures. To date, there has been no definitive evidence that boosting testosterone levels in older men is substantially beneficial or even safe. Studies have shown that T-Therapy may have some minor sexual benefits, but do not improve other measures of health. In fact, they are linked to heart attack, stimulating prostate cancer growth, blood clots, and worsened sleep apnea.
T-Therapy products are actually only approved to treat hypogonadism, which is an endocrine disorder that causes severe testosterone deficiency. The number of men who actually have diagnosed hypogonadism is quite low, so Big Pharma had to come up with a plan to make these products are profitable as possible.
Ultimately, Big Pharma chose to promote these products excessively, growing the T-Therapy market to $2 billion in 2012. Aging men is, after all, an enormous and never-ending market. Little do these men know T-Therapy is only approved – meaning only proven to be safe and effective – to treat a specific, uncommon endocrine disorder.
For a free legal consultation with a Testosterone Therapy Lawyer serving nationwide, call (800) 316-2828
All Studies Point to Heightened Risk
Two studies cited by the FDA tested the risk of sudden heart attack in males using T-Therapy. The larger study tracked 55,000 men’s health for three months after using T-therapy. Researchers found that the risk of suffering a heart attack more than doubled among men 65 and older after starting T-Therapy.
Researchers additionally found that men younger than 65 with clear indications of heart disease also showed a two- to three-fold increased risk of heart attack shortly after starting T-Therapy.
The smaller trial (about 200 patients) tested only older men with both low mobility and low testosterone levels. There were significantly more dangerous side effects in the group taking T-Therapy compared to a placebo, namely cardiac, skin, tissue, and respiratory disorders. The smaller trial stopped due to the increase in cardiac events in those taking T-Therapy.
Another study, in 2014, looked at nearly 9,000 men with low testosterone, 1,200 of which started T-Therapy. The men who took T-Therapy were 6% more likely to suffer a heart attack, stroke, or cardiac death.
Find all three studies here:
- PLOS ONE Research Article
- New England Journal of Medicine: Testosterone in Older Men with Mobility Limitations (TOM) Trial
- JAMA: Association of Testosterone Therapy with Mortality, Myocardial Infarction, and Stroke in men with Low Testosterone Levels
Testosterone Therapy Lawyer Near Me (800) 316-2828
Marketing Conquers Science
No one exactly knows where the term “low T” came from, but it is not a medically recognized condition, nor is there any agreement on what it means. In reality, Big Pharma purposefully advertised low T as a general condition – so general that it seems to affect nearly all men – to take advantage of a loophole in drug advertising laws.
The FDA tightly regulates drug advertising to make sure companies aren’t marketing their drugs off-label. The agency does not regulate “disease-awareness” campaigns, however, which simply bring attention to conditions (even made-up ones) without naming specific brands.
Big Pharma jumped on this opportunity, “raising awareness” for low T as a general condition affecting millions of men, convincing them that they were gaining fat, losing muscle, and had fewer erections because of low T. They promoted low T screening quizzes directly to men, encouraging them to ask their doctor for testosterone tests. They infiltrated TV, magazines, the Internet, and everywhere in between.
It was a brilliant marketing plan, and it paid off. In 2013, Medical Marketing & Media magazine named two AbbVie executives the “all-star large pharma marketing team of the year” for their low T awareness campaigns to promote AndroGel.
The most common forms of T-Therapy in the United States include:
- Topical Patches & Gels: Androderm, Androgel, Testim, and Testoderm
- Injections: Delatestryl and Depo-Testosterone
Far too many men are taking these drugs, needlessly exposing themselves to serious health risks and death. Physician and academic groups loudly criticize T-Therapy marketing ploys, claiming they harm public health by exaggerating T-Therapy’s effectiveness, downplaying risks, and posing low T as an important health problem, which it is not.
The Endocrine Society recommends against testosterone screening for the general population because levels fluctuate so wildly depending on the time of day, sleep quality, eating habits, and stress levels. Serious testosterone deficiency is an important problem. Natural decline in testosterone with age is not.
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The drug injury attorneys at Pintas & Mullins Law Firm are currently investigating cases of heart attack, stroke, and cardiac death in patients taking T-Therapy medications. Testosterone therapy lawsuits are consolidated in the Northern District of Illinois (MDL 2545).
If you or someone you love was prescribed a testosterone therapy and was hospitalized from complications, contact our dangerous drug lawyers immediately. We can answer any questions you may have about the therapy and your legal options, completely free of charge.
Call (800) 316-2828 anytime, 24 / 7 for a free case review. We handle testosterone therapy cases across the nation.
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