Robinson Calcagnie, Inc. Investigating Testosterone Therapy Injury Claims, Including Heart Attack and Stroke
Testosterone Therapy: A Billion Dollar Industry
In the last five years, the number of testosterone therapy prescriptions has more than doubled from 208 million in 2008 to 432 million in 2013. Almost 4 percent of men in the U.S. over the age of 60 are currently taking prescription testosterone, which generated over $2 billion in sales last year. Much of this demand is fueled by aggressive direct-to-consumer advertising on TV, radio and magazines, which link low testosterone levels, or “Low-T,” to symptoms such as weight gain, and reduced energy and libido.
Unfortunately, a number of recent studies suggest that testosterone therapy, especially in older men or men with pre-existing heart disease, may significantly increase the risk of heart attack, stroke, and other cardiovascular-related events. Experts warn that many men whose problems are not caused by low testosterone are needlessly putting themselves at risk.
Studies Suggest Testosterone Drugs May Increase the Risk of Heart Attack, Stroke, and other Cardiovascular Problems.
A January 2014 study published in the journal PLOS One, which looked at over 55,000 testosterone therapy patients, found that testosterone therapy more than doubled the risk of a non-fatal heart attack in men 65 years or older and more than tripled the risk in men 75 years or older. The study also found that testosterone therapy nearly tripled the risk of a heart attack in men under the age of 65 who had a prior history of heart disease. This large study, which was conducted by researchers at the University of California, Los Angeles, the National Institutes of Health and Consolidated Research, adds to a growing body of scientific literature linking testosterone therapy to cardiovascular disease.
An earlier study published in November 2013 edition of the Journal of the American Medical Association (JAMA) found that testosterone therapy raised the risk of death, heart attack and stroke by almost 30 percent in a group of veterans with a history of heart disease.
Additionally, an April 2013 article published in BMC Medicine reviewed a total of 27 clinical trials involving testosterone therapy and concluded that testosterone therapy increased the overall risk of cardiovascular-related events. The authors also disturbingly found that the risk of cardiovascular-related events was even greater in those clinical trials which were not funded by drug manufacturers.
A randomized clinical trial published in the New England Journal of Medicine in July 2010 also raised concerns about testosterone therapy given to older men. The trial was stopped early because a large number of patients on testosterone therapy experienced cardiovascular-related events. The study found that 23 of the 106 patients who took testosterone gel had cardiovascular-related events compared to only 5 of the 103 patients who received the placebo.
In response to the published PLOS One and JAMA articles, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication on January 31, 2014, announcing that it was “investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products.” The FDA also noted that “testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition.”
What Is Testosterone Therapy?
Testosterone is a steroid sex hormone responsible for maintaining muscle mass, red blood cells, bone growth, sexual function, and other physiological developments. It is natural for testosterone levels to decrease with age, and while testosterone treatments are recommended by doctors to treat hypogonadism – a disease that causes abnormally low testosterone levels – it is generally agreed that it is not often something that requires medical treatment. According to the FDA, treatments are only recommended “for use in men who either no longer produce the male sex hormone testosterone or produce it in very low amounts.”
Brand-name prescription testosterone therapies include: AndroGel, AndroDerm, Axiron, Testim and Fortesta. Testosterone treatments come in a variety of forms including gels, trans-dermal patches, injections, implants and pills.
Aggressive “Low-T” Advertising
According to FiercePharma.com, drug manufacturers spent $3.47 billion in 2012 on advertising directed at consumers. The maker of AndroGel alone spent $80 million in advertising. Much of this direct-to-consumer advertising consists of television, radio, magazine and newspaper ads that target older men and focus on reduced energy and sex drive. Such commercials encourage men to talk to their doctors about “low testosterone” or “Low T.” Judging by the dramatic increase in prescriptions, these marketing efforts have been extremely effective in convincing men over 40 that they need testosterone therapy.
An article in the New York Times observed that testosterone therapies, which were once a niche treatment for men suffering from hormonal deficiencies, are increasingly being sold as “lifestyle products” to boost naturally dropping testosterone levels. According to the article, many physicians feel that “Low T” is mostly an invented condition driven by pharmaceutical marketing.
As stated by the FDA, testosterone therapies are indicated for hypogonadism, which results in very little or no male sex hormone production. They are not indicated or approved to treat “low testosterone,” lack of energy, reduced libido, or any other conditions. Yet, as a January 2014, a USA Today article citing a study published in JAMA Internal Medicine, pointed out that only about half of men taking testosterone therapy had been diagnosed with hypogonadism, and 25 percent hadn’t even had their testosterone levels tested. The remaining patients had been diagnosed with other problems such as fatigue or sexual dysfunction.
Experts have expressed concerns that drug manufacturers are overselling testosterone to men who don’t need it and thereby putting them at unnecessary risk of cardiovascular disease or other serious side effects. According to Dr. Steven Nissen, the chair of cardiovascular medicine at the Cleveland Clinic, prescribing testosterone therapy to thousands of men who may not really need it is a “gigantic experiment.”
Helping Those Injured by Testosterone Therapy
The product liability lawyers at Robinson Calcagnie, Inc. are currently investigating claims on behalf of testosterone therapy users who have suffered serious health problems, including:
- heart attack
- coronary heart disease, requiring stent or bypass surgery
- pulmonary embolism (PE)
- deep vein thrombosis (DVT)
Our firm has established a reputation throughout the country as one of the nation’s leading personal injury and product liability law firms. Our attorneys have represented thousands of clients in cases involving dangerous or defective drugs, and have obtained dozens of multi-million dollar settlements, verdicts and judgments.
If you or someone you know has taken testosterone and suffered a heart attack, stroke, pulmonary embolism, deep vein thrombosis, death or other side effect, please don’t hesitate to call our Robinson Calcagnie, Inc. attorneys at (888) 701-1288 or fill out an online form for a free case evaluation.